Thermal Environments of Arctic Soil Organisms during Winter

first_imgThis paper compares winter soil temperatures at five high arctic sites (Ny Alesund, West Spitsbergen) and one subarctic site (Slattatjakka, Abisko) during 1992/93 and 1993/94. At the high arctic sites snow cover afforded slight insulation where minimum air temperatures were as low as -32 degrees C (March 1993). However, snow did not accumulate significantly until late winter, by which time the ground had cooled to approximately -20 degrees C. The polar night aided soil cooling by minimizing solar heat gain. Soil temperatures at 3 cm depth during the autumn freeze were initially higher than surface temperatures, but once frozen, the zone inhabited by soil microarthropods (approximately 10 cm depth) remained isothermal and closely tracked air temperature. By contrast, throughout the spring thaw, the soil at 3 cm depth was cooler than the surface. Hence, snow cover reduced absolute minimum temperatures in late winter but prolonged the effective winter period. Hence soil organisms may be inactive for up to 79% (289 d) of the year, owing to the extended period that the ground is frozen. The incidence of daily ground freeze/thaw events was reduced at high arctic sites compared with a subarctic location. Similarly, there were differences in temperature means and minima at the adjacent high arctic sites dependent on location and topography; for example, on opposite coasts of the Broggerhaloya, West Spitsbergen the minimum temperatures in 1993/94 were -15.7 degrees C (Stuphallet) and -8.2 degrees C (Kjaerstranda). Terrestrial microarthropods inhabiting sites with late snow accumulation and cold air temperatures experience extreme low soil temperatures and hence require effective cold-hardiness strategies.last_img read more

UVU Baseball Hosts New Mexico State Thursday

first_img Brad James Written by Junior right-handed pitcher Jesse Schmit is the Wolverines’ leading pitcher in wins, at 2-5 and fellow junior right-handed hurler Paxton Schultz leads Utah Valley with 57 strikeouts. Tags: Alexander Marco/Brock Whittlesey/Chance Hroch/Jesse Schmit/Joey Ortiz/New Mexico State/Nick Gonzales/Paxton Schultz/Ryan Eastburn/Sacramento State/Texas-Rio Grande Valley/UVU Baseball The Wolverines are currently on a 3-game losing streak while the Aggies are currently tied for first place in the WAC with Texas-Rio Grande Valley and Sacramento State. Junior right-handed pitcher Chance Hroch is 7-0 on the season with a 2.90 ERA for New Mexico State) and senior right-handed pitcher Brock Whittlesey ( a team-best 49 strikeouts). Utah Valley is led by senior outfielder Ryan Eastburn (a .351 batting average) and junior outfielder Alexander Marco (6 home runs, 28 RBI). The Aggies lead the Wolverines 11-9 in the all-time series. April 18, 2019 /Sports News – Local UVU Baseball Hosts New Mexico State Thursday The Aggies are led by sophomore infielder/outfielder Nick Gonzales (a .454 batting average, 12 home runs, 58 RBI) and junior infielder Joey Ortiz (a Division I-leading 63 RBI, 7 home runs, a .438 batting average). FacebookTwitterLinkedInEmailOREM, Utah-Thursday through Saturday, Utah Valley baseball (8-28, 5-7 in WAC play) hosts New Mexico State (26-9, 9-3 in WAC play) for a three-game series at UCCU Ballpark.last_img read more

Bertram Notches Another WEF 6 Win in $137,000 Grand Prix

first_img Email* We’ll send you our regular newsletter and include you in our monthly giveaways. PLUS, you’ll receive our exclusive Rider Fitness digital edition with 15 exercises for more effective riding. Opening the final day of week six at the 2021 Winter Equestrian Festival (WEF), it was Bertram Allen (IRL) and Castlefield Vegas, owned by Martin Egan, taking the top spot in the 137,000 IDA Development Grand Prix CSI3* held on the grass Derby Field at Equestrian Village, on Sunday, February 21.WEF 7 brings CSI5* competition, along with a concurrent CSI2*, back to the International Arena at PBIEC on February 24-28 sponsored by Lugano Diamonds with weekly highlights including: the $37,000 Douglas Elliman Real Estate 1.45m CSI5* on Wednesday, Thursday’s $73,000 Adequan® WEF Challenge Cup Round 7, the $37,000 Bainbridge Companies 1.45m Classic CSI5* and $37,000 Griffis Residential 1.45m Qualifier CSI2* on Friday, the $401,000 Lugano Diamonds Grand Prix CSI5* as part of “Saturday Night Lights,” and the $73,000 CaptiveOne Advisors 1.50m Classic CSI5* and $50,000 Griffis Residential Grand Prix CSI2* on Sunday.Hunters will be featured on the grass Derby Field at Equestrian Village on Friday, February 26, in the $10,000 USHJA National Hunter Derby, with the professional section presented by Restylane and a junior/amateur section. Spectators can watch feature classes live and on demand for free using the livestream.In the first round of Sunday’s grand prix, the final line on course featured a triple combination [vertical, oxer, vertical] followed by five strides down to the IDA Developments oxer, the final jump on course. This combination of jumps proved to be one of the most difficult sections of the track designed by Catsy Cruz (MEX). A starting field of 45 combinations challenged the course, with 18 qualifying to return for the jump-off.Fresh off their victory in the Adequan® WEF Challenge Cup on Friday, Allen and the 11-year-old Irish Sport Horse gelding by Cassino x Lux Z did it again, putting forth a blistering double-clear effort to stop the clock in 37.10 seconds.“I knew I just had to give it everything I had,” said the 26-year-old rider. “I didn’t watch Nayel’s round, but I was talking to a few people and they said it was very fast and my guy is naturally fast, so my plan was to just be as fast as I could be without doing anything crazy. It all came up great. Friday was the biggest class he’s [Castlefield Vegas] jumped so far, and he won that, so I was delighted. Today I was interested to see how he would go along with that. He jumped great, and I had a good feeling.”Less than three-tenths of a second off the leader, Egypt’s Nayel Nassar rode Igor Van De Wittemoere owned by Evergate Stables, LLC, to a second-place finish. Nassar and the 13-year-old gelding by Cooper VD Heffinck x Orlando 96, also posted a double-clear round in 37.39 seconds. The pair has been together for about a year now so their success on Sunday comes as a very exciting step in the right direction.“It has been a bit of a process trying to get him going the way I would like him to,” said the 30-year-old rider. “He has a ton of energy and so much blood, and sometimes he tends to rush the jumps a bit. We’ve been messing around with bridles and doing a lot of flatwork just to try to get him to switch a few gears, and I was so pleased with him today. He jumped the first round spectacularly and came back to jump the jump-off even better. I thought we had it won, but this guy [Bertram] is pretty darn fast. We are so happy with the result and just very pleased with how he’s coming along.”Rounding out the top three it was Paul O’Shea (IRL) and Skara Glen’s Chancelloress, owned by Skara Glen Stables, leaving all the jumps in their cups in a time of 38.35 seconds. O’Shea and the 12-year-old Dutch Warmblood mare by Chacco Blue x Balou du Rouet had a successful week overall, after also finishing third in Friday’s qualifier. Top Canadian in the class was Jacqueline Steffens riding Freaky Liefhebber, who placed 7th.“I thought it was a great course,” said O’Shea, who is ranked 40th in the world. “I was very happy with my mare. She was good the other day too, so I think we went as quick as we could. I’m very happy with her, and at least another Irishman won! Bertram’s horse is co-owned by a very good friend of mine, so it’s great to see them going so well.”Allen, who sits 46th in the world rankings, echoed the praise of other international competitors of the quality of the turf, after racking up three wins to date with Castlefield Vegas on the grass Derby Field during the 2021 WEF.“Everyone is delighted to be able to jump on the grass,” he said with a smile. “There is so much space and everyone loves jumping out here, so it’s nice.”Final Results: $137,000 IDA Development Grand Prix CSI3*1. CASTLEFIELD VEGAS: 2010 ISH gelding by Cassino x Lux ZBERTRAM ALLEN (IRL), Martin Egan: 0/0/37.102. IGOR VAN DE WITTEMOERE: 2008 Belgian Warmblood gelding by Cooper VD Heffinck x Orlando 96NAYEL NASSAR (EGY), Evergate Stables, LLC: 0/0/37.393. SKARA GLEN’S CHANCELLORESS: 2009 KWPN mare by Chacco Blue x Balou du RouetPAUL O’SHEA (IRL), Skara Glen Stables: 0/0/38.354. LEGACY: 2010 Zangersheide mare by Chippendale Z x Bon AmiDANIEL COYLE (IRL), Ariel Grange: 0/0/38.455. URHELIA LUTTERBACH: 2008 Selle Français mare by Helios De La Cour Ii x EmilionDARRAGH KENNY (IRL), Kerry McCahill: 0/0/38.706. CHIC HIN D HYRENCOURT: 2008 SBS gelding by Taran de la Pomme x ElanvilleBEEZIE MADDEN (USA), Abigail Wexner: 0/0/40.337. FREAKY LIEFHEBBER: 2010 Dutch Warmblood by Darco x Litho xJACQUELINE STEFFENS (CAN) Jacqueline Steffens: 0/0/40.728. QU ALFONS SANTO ANTONIO: 2007 ESH gelding by Aromats x False PassYURI MANSUR (BRA), Yuri Mansur: 0/0/41.519. SKYHORSE: 2007 Belgian Warmblood gelding by Calvaro x Quidam de RevelLILLIE KEENAN (USA), Chansonette Farm LLC: 0/0/42.7010. H5 JUST THE MUSIC: 2009 BWP gelding by Tornedo FCS x Quidam de RevelCARLOS HANK GUERREIRO (MEX), H5 Stables: 0/0/43.06 More from News:MARS Bromont CCI Announces Requirements For US-Based RidersThe first set of requirements to allow American athletes and support teams to enter Canada for the June 2-6 competition have been released.Canadian Eventer Jessica Phoenix Reaches the 100 CCI4*-S MarkPhoenix achieved the milestone while riding Pavarotti at the inaugural 2021 CCI4*-S at the Land Rover Kentucky Three-Day Event.Tribunal Satisfied That Kocher Made Prolonged Use of Electric SpursAs well as horse abuse, the US rider is found to have brought the sport into disrepute and committed criminal acts under Swiss law.Washington International Horse Show Returns to TryonTIEC will again provide the venue for the WIHS Oct. 26-31 with a full schedule of hunter, jumper and equitation classes. Subscribe to the Horse Sport newsletter and get an exclusive bonus digital edition!center_img Horse Sport Enews SIGN UP Tags: WEF, show jumping, Winter Equestrian Festival, Castlefield Vegas, Bertram Allen (IRL), IDA Development Grand Prix CSI3*, last_img read more

Lady Sponsor Elected for RFA Tidespring

first_imgBack to overview,Home naval-today Lady Sponsor Elected for RFA Tidespring Lady Sponsor Elected for RFA Tidespring View post tag: Naval Authorities View post tag: Elected View post tag: europe View post tag: Navy Lady Boyce, the wife of former First Sea Lord and Chief of Defence Staff Admiral of the Fleet the Lord Boyce, has accepted the invitation to be the tanker’s sponsor – acting as “the embodiment of her spirit, forging a close relations with both the vessel and her crew” following every milestone in the ship’s life.center_img September 3, 2014 View post tag: RFA Tidespring View post tag: News by topic View post tag: Lady Sponsor Lady Boyce is due to see her ship for the first time in the autumn of 2015 when the formal naming ceremony will take place at the DSME yard in Okpo-dong near the south-eastern tip of South Korea.Construction of Tidespring began on June 24 with the head of the Royal Fleet Auxiliary, Commodore Rob Dorey, performing the honours by getting steel cutting under way.The tanker will be built in blocks and pieced together in dry dock over the winter.After trials off Korea, the tanker, which is being built to a British design as part of a project to replace the RFA’s older tankers, will be brought to the UK to have more sensitive military equipment and communications systems installed ahead of entering service in 2016.By the end of the decade, Tidespring and her three sisters – Tiderace, Tidesurge and Tideforce – will be the mainstay of operations by Royal Navy ships and task groups around the globe, in particular the carrier battle groups formed around HMS Queen Elizabeth and Prince of Wales.The last tanker to bear the Tidespring name served the Royal Fleet Auxiliary for 30 years from 1962 until 1992 and saw action in Aden Withdrawal (1967-68) and Monrovia (1990).Most notably in 1982, however, she found herself in harm’s way supporting the task force sent to liberate the Falklands.In addition to providing fuel for Royal Navy vessels, the tanker was home to a company of Royal Marines commandos during the recapture of South Georgia.Those actions helped the ship earn the Tidespring name its first battle honour.The board carrying it, plus the ship’s badge, was kept when the tanker was paid off in the early 1990s and after making the 6,000-mile journey from Britain to South Korea is ready to enjoy pride of place on the new ship.[mappress]Press Release, September 03, 2014; Image: UK Navy Share this articlelast_img read more

Protest At Evansville Planned Parenthood Facility On August 22 Warns: “Planned Parenthood Sells Baby…

first_img PRESS RELEASE FROM RIGHT TO LIFE OF SOUTHWEST IN. In light of recent revelations that Planned Parenthood has been harvesting and selling aborted baby parts, Right to Life of Southwest IN and concerned citizens of southwest Indiana are calling for a protest at the Planned Parenthood facility at 125 N. Weinbach Ave. in Evansvilleon August 22 from 9 a.m. to 11 a.m. This effort is part of a National Day of Protest taking place at Planned Parenthood offices and abortion facilities all across the United States (http://www.protestpp.com) to raise awareness about Planned Parenthood’s trafficking of aborted baby parts.Undercover videos (see links below) released by the Center for Medical Progress reveal that Planned Parenthood abortion clinics, with the sanction of the Planned Parenthood Federation of America, are involved in the harvesting of body parts of unborn children aborted in their facilities and profiting from their sale contrary to federal laws prohibiting such practices. The videos show high-level Planned Parenthood executives haggling over the prices of fetal specimens. The videos also raise ethical questions about the exploitation of unborn children for financial gain and risks to women’s health if abortion procedures are altered solely to procure more profitable specimens.As a consequence of this public scandal, several states have initiated investigations of Planned Parenthood and legislation has been introduced in Congress to defund the abortion giant. Planned Parenthood currently receives over $500 million in taxpayer funding annually.WHO: Right to Life of Southwest IN & Concerned citizens of Southwest IndianaWHAT: Press conference, prayer vigil and protest signs calling attention to PP’s baby parts traffickingWHERE: Planned Parenthood, 125 N. Weinbach Ave, Evansville, INWHEN: August 22, 2015 from 9:00 a.m. to11:00 a.m.The ProtestPP.com coalition is headed by Citizens for a Pro-Life Society, Created Equal, 40 Days for Life and the Pro-Life Action League, and is co-sponsored by fifty state and national pro-life organizations.Local spokesperson Mary Ellen Van Dyke said:“All politics is local. We cannot only look to Washington, DC and our state governments to solve this problem. Planned Parenthood is located in large and small communities all across America. Each community with a Planned Parenthood abortion clinic or satellite office needs to take action against the killing of babies and the trafficking of their body parts. Concerned local citizens from southwest Indiana will be sending the message that it’s well past time for Planned Parenthood to be run out of town!”Links to the first three Center for Medical Progress undercover videos:Video 1: https://www.youtube.com/watch?v=jjxwVuozMnUVideo 2: https://www.youtube.com/watch?v=MjCs_gvImywVideo 3: https://www.youtube.com/watch?v=Xw2xi9mhmuoFacebookTwitterCopy LinkEmailSharelast_img read more

Registration Open for Summer Music, Theater and Dance Camps, Classes

first_imgNews release from the Ocean City Theatre Company:The Greater Ocean City Theatre Company will be offering an exciting array of camps and classes this summer. The lineup includes programs that are designed for the youngest students and serve as an introduction to the performing arts, as well as, classes for students with an extensive performing arts background.“Our arts educational programming continues to grow into a rewarding part of the Greater Ocean City Theatre Company” says Michael Hartman, OCTC Artistic Director. “Students who participate in summer programming experience the perfect balance of learning and fun while being exposed to a professional and creative environment.”Below is a listing of class offerings that are still open. Enrollment is limited! To sign-up or for more information, visit www.oceancitytheatrecompany.com or call 609-398-1118.MUSICAL THEATRE INTENSIVE: JULY 21-JULY 25, 2014OCTC is excited to offer an opportunity for students to work with theatre professionals and develop key skills for theatre auditions on a local, school, collegiate and professional level.GUYS AND DOLLS MASTER CLASS FOR STUDENTS IN 6TH – 12TH GRADES: JULY 10, 2014Learn the actual Broadway style choreography from the Greater Ocean City Theatre Company’s professional Mainstage production of “GUYS AND DOLLS” right on the set, from our professional choreographer.THEATRE CAMP SESSION 2: JULY 21 – AUGUST 2, 2014Casting will begin the first day of camp as students prepare for a rewarding theatre experience performing the fully staged production RAPUNZEL. This show is not a musical so it is a great way to feature kids who do not like to sing/dance and allows kids who have a musical theatre background the opportunity to experience a play! This camp is open to students in 3rd – 8th grades.DANCE WEEK 2014! –  GRADES 5TH – 12TH: JULY 28 – AUGUST 1, 2013Each day will start with a group warm up and then the camp will split based on ability level and age.  Various professional dance instructors, choreographers and dancers will teach the class so the kids will be exposed to a wide form of dance stylesIMAGINATION STATION THEATRE CAMP FOR K-2ND: AUGUST 4-8, 2014New for 2014! This one week camp is geared for younger performers looking to gain experience in a fun, safe and imaginative setting. This creative time is perfect for your little one who already has aspirations of being a star.  Kids will experience creative movement, improvisational skills, mime, theatre games, storytelling, reader’s theatre and much more in this jam-packed, high-energy camp.  There will be an informal presentation at the end of the camp. The future stars of OCTC will have a chance to perform for their families at this informal show in our rehearsal studio.APPEAR IN OCTC’S PRODUCTION OF THE ORIGINAL BROADWAY MUSICAL SWING!  FEATURED DANCE ENSEMBLE FOR DANCERS IN 9TH-12TH GRADES AS OF FALL 2014Have the chance to work with a professional production team and professional cast of musical theatre performers/dancers in SWING! OCTC is casting a small-featured dance ensemble of High School dancers to appear in our Broadway musical with the Ocean City POPS Orchestra and our cast of NYC performers.  This featured dance ensemble will appear in a few special numbers during the show. With songs like Sing, Sing, Sing! and In The Mood this ensemble will have a blast learning the swing/jazz style that brings this musical to life. Partner that with the chance to appear with a professional orchestra at the historic Ocean City Music Pier and you will create a very special memory!JOIN THE PROFESSIONAL CAST OF JOSEPH AND THE AMAZING TECHNICOLOR DREAMCOAT AS A MEMBER OF THE “JOSEPH CHILDREN’S ENSEMBLE”New for 2014! Kids in grades 3rd – 6th grades will have the opportunity to appear along side our professional cast of performers in the Broadway Smash – JOSEPH AND THE AMAZING TECHNICOLOR DREAMCOAT. Kids participating in this energetic and colorful production will be featured in the Children’s Chorus of the show. The chorus will be highlighted during the entire production with fun staging, riser choreography and lots of singing!  Participants should have some experience with vocal music.PRIVATE ACTING LESSONS Grades 6th-12th GradeExperience one-on-one private acting lessons to perfect acting technique with trained instructors who have experience working to prepare for college auditions and school auditions. Develop personalized skills to make you a stronger, more confident performer. Private coaching can be generally technique based or targeted toward a specific role, monologue and/or upcoming audition preparation.PRIVATE VOICE LESSONS Grades 4th-12thExperience one-on-one private vocal lessons to perfect vocal technique and singing skills with trained music instructors who have experience working to prepare for college auditions, school singing, musical theatre, classical music and choral works.JUNIOR COMPANYOCTC’s Prestigious Junior Company will be split into two groups for 2014. The Junior Company is select group of students with a passion for musical theatre. Members of the Jr. Co. rehearse and star in a fully staged Broadway musical each summer. The 6th-8th Grade students will present THE MUSIC MAN Junior and 9th – 12th Grade students will present a musical that can not be announced at this time due to restrictions! Auditions will be held on May 4, 2014. Learn more about the requirements and audition process on our website.OCTC will once again collaborate with the City’s Recreation Department to present the annual two-week theatre camp that has become so popular over the years. Registration for the camp with is done through the City of Ocean City’s Recreation Sign Up process on May 1, 2014. This camp usually fills up within the first hour of registrationThere is limited enrollment for all camps and classes so we encourage early sign ups to reserve your space. Last year most camps filled up before May! To learn more about the company, visitwww.oceancitytheatrecompany.com for more informationlast_img read more

Detailed guide: Good manufacturing practice and good distribution practice

first_img interview relevant personnel review documents conduct site visits Co-ordination group for Mutual Recognition and Decentralised Procedures – human (CMDh). Types of inspectionInspections under the risk-based compliance programmeEvery manufacturer and wholesaler has a risk rating or score and we prioritise inspections for those with the highest ratings or scores. You will be told about these inspections in advance, although under the short-notice inspection programme we may send little or no notification. At the inspection, GMP and/or GDP inspectors examine the systems used to manufacture and/or distribute medicines.Your GMP rating is based on: Good distribution practice (GDP) requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by the MA or product specification.Organisations that may have to comply with good manufacturing practice (GMP) and/or good distribution practice (GDP) include: You can’t appeal against your rating.An increase in risk will be peer reviewed by a GMP operations manager, a member of the compliance management team (CMT) or a GMP expert inspector before being finalised.You will be given a full copy of the reasons for your risk rating once the inspection has closed.For GDP inspections your risk score is based on what activities take place on site and the number and type of deficiencies observed. This indicates the likely date of your next inspection and this information is included on the inspection report.Inspections may sometimes be carried out with other MHRA inspections, such as with good clinical practice or good pharmacovigilance practice.Product-related GMP inspectionsMHRA conducts product-related GMP inspections when assessing an application for a UK marketing authorisation. This inspection checks if the manufacturer complies with GMP. We tell you about this inspection in advance.Product-related inspections can also be requested by the European Medicines Agency (EMA): Guidance for UK manufacturer’s licence and manufacturer’s authorisation holders (for investigational medicinal products) – on the use of stand alone contract laboratories (PDF, 185KB, 3 pages) – on the use of stand alone contract laboratories manufacturing areas quality control (QC) laboratories stock and stock management storage areas temperature monitoring returns areas purchasing and sales functions transportation arrangements GDP compliance report (MS Word Document, 251KB) GMP pre-inspection compliance report (MS Word Document, 404KB) GMP interim compliance report (MS Word Document, 342KB) GMP compliance report and interim update guidance (PDF, 104KB, 7 pages) GMP Quality Control Laboratory Pre-Inspection Compliance Report (MS Word Document, 56.2KB) GMP QC compliance report and interim update guidance (PDF, 156KB, 6 pages) your compliance report internal information about previous inspection history organisational changes MHRA carries out inspections to check if manufacturing and distribution sites comply with GMP or GDP. You will be inspected when you apply for a manufacturer or wholesaler dealer licence and then periodically based on risk assessments. Overseas manufacturing sites are also inspected.If an organisation manufactures or distributes both human and veterinary medicines, MHRA may carry out an inspection of both areas on behalf of the Veterinary Medicines Directorate.MHRA and the European Medicines Agency (EMA) have published guidance on GMP and GDP. Site visits may include any facility or process involved in producing, purchasing and distributing medicines, including: OverviewGood manufacturing practice (GMP) is the minimum standard that a medicines manufacturer must meet in their production processes. Products must: Volume 4 of the rules governing medicinal products in the EU be of consistent high quality be appropriate to their intended use meet the requirements of the marketing authorisation (MA) or product specification manufacturer licence holders wholesale dealer licence holders blood establishment authorisation holders non-UK sites employed by UK MA holderscenter_img EMA uses inspectors from EU member states to ensure compliance with GMP principles.Triggered inspectionsMHRA may inspect you if we’re informed about possible GMP or GDP breaches by: We may send little or no notification of these inspections in advance.Complete a compliance reportYou will have to complete either a GDP or GMP compliance report before an before an inspection unless it is a triggered inspection which are only notified at short notice.You should send completed compliance reports to the email address given by the inspector. Hard copies of compliance reports will not be accepted. a whistle blower other MHRA departments another regulatory authority OtherA deficiency which cannot be classified as either critical or major or there is not enough information to classify it as critical or major but which indicates a departure from good manufacturing and distribution practice.Actions after the inspectionAfter the inspection closing meeting, you will receive a post inspection letter confirming any deficiencies found.You must respond to the inspector by email to confirm the proposed corrective actions and dates for when these actions will be completed. The inspector will review your response. If they accept it, you will receive a GMP or GDP certificate with your inspection report. An unacceptable response may lead to compliance escalation if further requests for information are unsatisfactory.If you’re being inspected for GMP you should complete an interim assessment if there are changes to your site following your first inspection.Guidance on responding to a post-inspection letterThe daily rate inspection fee includes preparation for, reporting and close-out of the inspection. Inspections with critical findings or other significant non-compliance requiring referral to the GMDP Compliance Management Team and/or Inspection Action Group may require the inspector(s) to spend additional time beyond that covered by the daily rate overseeing the adequacy of the company’s Corrective and Preventative Actions (CAPA) and the company’s return to compliance. For such inspections, an office-based inspection fee may be charged for this additional time spent by the inspector(s) on such activities (for example, reviewing CAPA plans, impact assessments and periodic CAPA status updates).Compliance escalation processIf your compliance is found to be poor but has not hit the threshold for regulatory action you may go through the compliance escalation process. The aim of this process is to support companies to achieve compliance before regulatory action becomes necessary.Once the process has been completed you will be returned to the routine risk-based inspection programme. However you could still be referred for regulatory action if you do not make the necessary improvements.The process may also be used if the Inspection Action Group has closed their case referral but the company to be monitored until remedial action plans have been completed.The process may include: The inspectionDuring an inspection the inspection team will: making recommendations on close monitoring of compliance improvement work through inspection meetings and correspondence with company senior management clearly outlining the consequences of continued non-compliance has or may produce a product that doesn’t comply with its marketing authorisation indicates a major deviation from GMP or GDP or from the terms of the manufacturer licence or wholesale licence indicates a failure to carry out satisfactory batch release procedures or (within EU) a failure of the Qualified Person or Responsible Person to fulfil their legal duties a combination of several ‘other’ deficiencies which on their own may not be major but together may represent a major deficiency and should be explained and reported as such Committee for Human Medicinal products (CHMp) during the pre-application of a centralised marketing authorisation application Information on new arrangements for inspections during the coronavirus (COVID-19) outbreak. Exceptional good distribution practice (GDP) flexibilities for medicines during the coronavirus (COVID-19) outbreak EU GDP guidelines. Orange Guide: Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017 Green Guide: Rules and Guidance for Pharmaceutical Distributors 2017. The inspection team may ask for additional documentation and samples for testing during the inspection. They may also change the focus of the inspection if they suspect serious non-compliance.At the closing meeting the inspector will provide feedback and discuss any deficiencies with you and agree timelines for corrective actions.Grading of inspection findingsDeficiencies found during inspections are graded at 3 levels. The definitions below are summaries. For the full definition see page 47 of the EMA compilation of community procedures on inspections and exchange of informationCritical deficiencyA deficiency which has produced or significantly risks producing a product which is harmful to humans or veterinary patients or which could result in a harmful residue in a food-producing animal.Any departure from good distribution practice that results in a significant risk to patients. This includes an activity which increases the risk of counterfeit medicines reaching patients.Major deficiencyA non-critical deficiency which: Information sheetsRe-inspection of site under Compliance Management (PDF, 29.3KB, 1 page)Compliance Management – Specials Manufacturers (PDF, 36.1KB, 1 page)Compliance Management – MIA MIA(IMP) and third country manufacture (PDF, 37.4KB, 2 pages)Compliance Management – Contract Laboratory (PDF, 29.4KB, 1 page)Compliance Management – Active Substance (PDF, 29.6KB, 1 page)Regulatory action – UK Wholesaler (PDF, 83.7KB, 2 pages)Feedback from GMP inspectionsTo help you understand the areas where GMP inspectors have found compliance problems during GMP inspections in the UK and overseas, the GMP inspectorate produces a report of common deficiencies from previous GMP inspections.The GMP Inspectorate has compiled an anonymised raw data set, so that stakeholders can do their own tailored analysis of our findings specific to their supply chain.Suspension of your licenceIf the inspector finds critical deficiencies or that agreed action plans from previous inspection deficiencies have not been resolved they will contact the Inspection Action Group (IAG). The IAG can refuse or suspend your licence, increase inspection visits or request a meeting with the licence holder.Information SheetsRe-inspection of site under Regulatory Action (PDF, 32.4KB, 1 page)Regulatory Action – Specials manufacturers (PDF, 37.9KB, 2 pages)Regulatory Action – MIA MIA(IMP) and Third Country manufacture (PDF, 39.5KB, 2 pages)Regulatory Action Contract Laboratory (PDF, 33.6KB, 2 pages)Regulatory Action – Active Substance (PDF, 34.1KB, 2 pages)Deficiency data (2018) (MS Excel Spreadsheet, 456KB)Transitional Qualified Persons (QPs) for investigational medicinal products (IMPs)We are aware there is some concern for UK business and personal careers, over the status of transitional QPs that were recognised under the transitional arrangements provided in SI 2004/1031, when the Clinical Trials Directive was implemented in 2004. Under the Clinical Trials Regulation EU No. 536/2014 Article 61, 2b., QPs will need to fulfil the conditions of qualification set out in Article 49(2) and (3) of Directive 2001/83/EC. The GMDP Inspectorate has worked closely with MHRA’s legal advisors to ensure that the original qualification eligibility assessments made between 2004-2006 remain valid, and that transitional QPs can continue to be considered eligible where their qualifications are also supported by at least 2 years practical experience from working in a licenced manufacturing facility.The GMDP Inspectorate have launched a reassessment process to give transitional QPs for IMP the opportunity to demonstrate how they now meet Article 49(2) & (3) of Directive 2001/83/EC, in line with the requirements of EU Regulation 536/2014 and applicants will need to complete the Transitional Qualified Persons reassessment form (MS Word Document, 374KB). This information will be used to provide a summary of qualifications and work experiences of acting in a transitional QP role to date, and will be added to information provided with the original 2004 – 2006 applications. There is no charge for the application and completed forms should be emailed to [email protected] for assessment. Following assessment, eligibility certificates will be issued to those meeting the requirements set out in set out in Article 49(2) and (3) of Directive 2001/83/EC.The reassessment process only applies to applicants who were assessed and acknowledged as transitional QPs under the SI 2004/1031 arrangements, which means transitional QPs that have been named as a QP in a valid application for a manufacturing authorisation for IMPs made prior to 1st May 2006 under the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031). This scheme is not open to any new trainee QPs wanting to specialise in the IMP sector, who would need to apply for eligibility assessment through the Joint Professional Bodies category A assessment route.Fees for inspectionFees for GMP and GDP inspections.ContactFor further information on good manufacturing and distribution practices, email [email protected] or [email protected] further information on the planning of GMP inspections, email [email protected] and for GDP inspections [email protected] inspections from 1 January 2021From 1 January 2021, the MHRA’s GxP risk-based inspection programmes will remain unchanged.GMP inspection outcomes from EEA regulatory authorities will continue to be recognised under a new mutual recognition agreement.Inspections performed by existing mutual recognition partners will also continue to be accepted, if they are within the scope of the mutual recognition agreement in place before 1 January 2021.last_img read more

Signature raises wages to mitigate Brexit concerns

first_imgSignature Flatbreads is to pay its staff the living wage and has created 50 new jobs at its Dunstable factory.The company said the decision to raise the wage rate of its permanent factory workers from the National Living Wage of £8.21 to the Real Living Wage of £9 per hour was designed to offer certainty and stability to staff. The company also hopes to eventually offer the Real Living Wage to all agency staff.Almost two-thirds of workers at the Dunstable site are non-British EU citizens, and the company said many had been left unsettled by the lengthy ongoing Brexit negotiations.“Our business is only as good as the people who work within it, and we are fortunate to have a dedicated and loyal workforce,” added Signature Flatbreads joint managing director Zizou Benchaoui. “We want to reassure our employees that we will be providing security during this uncertain time.”The moves come a year after Signature – which was named Bakery Manufacturer of the Year in the 2015 Baking Industry Awards – bought out its joint venture partner Aryzta.The company has also created 50 new jobs in 2019, after winning new business and adding two new production lines at Dunstable.Signature said its stability had been demonstrated by the recent launch of new Deli Kitchen products and growing significance of its exports to non-EU countries. The company supplies flatbreads, including tortilla wraps, pitta and naan bread, to major UK retailers and foodservice operators, as well as to 30 countries.“Manufacturing top-quality products is essential to our success, so we believe this significant and ongoing investment is a clear signal to the industry of our confidence as a business, as well as to our staff, recognising their importance,” added Benchaoui.“The addition of our two new lines will enable us to keep up with the growing global demand for our flatbreads, while also offering employment opportunities to a considerable number of new workers.”Founded in 1984 by the Eid family as Honeytop Speciality Foods, Signature was acquired by Aryzta in 2011 and sold back to the Eid family as part of an Aryzta restructure.last_img read more

Processed meats come with increased risk of heart disease, diabetes

first_imgIn a new study, researchers from the Harvard School of Public Health (HSPH) have found that eating processed meat, such as bacon, sausage, or processed deli meats, led to a 42 percent higher risk of heart disease and a 19 percent higher risk of type 2 diabetes. In contrast, the researchers did not find any higher risk of heart disease or diabetes among individuals eating unprocessed red meat, such as from beef, pork, or lamb.This work, which appears in today’s online edition of the journal Circulation, is the first systematic review and meta-analysis of the worldwide evidence for how eating unprocessed red meat and processed meat relates to risk of cardiovascular diseases and diabetes.“Although most dietary guidelines recommend reducing meat consumption, prior individual studies have shown mixed results for relationships between meat consumption and cardiovascular diseases and diabetes,” said Renata Micha, a research fellow in the Department of Epidemiology at HSPH and lead author of the study. “Most prior studies also did not separately consider the health effects of eating unprocessed red versus processed meats.”The researchers, led by Micha and HSPH colleagues Dariush Mozaffarian, assistant professor in the Department of Epidemiology, and Sarah Wallace, junior research fellow in the Department of Epidemiology, systematically reviewed nearly 1,600 studies. Twenty relevant studies were identified, which included more than 1.2 million individuals from 10 countries on four continents (United States, Europe, Australia, and Asia).The researchers defined unprocessed red meat as any unprocessed meat from beef, lamb, or pork, excluding poultry. Processed meat was defined as any meatpreserved by smoking, curing, or salting, or with the addition of chemical preservatives. Examples include bacon, salami, sausages, hot dogs, or processed deli or luncheon meats. Vegetable or seafood protein sources were not evaluated in these studies.The results showed that, on average, each 50 gram (1.8 ounce) daily serving of processed meat (about one to two slices of deli meats or one hot dog) was associated with a 42 percent higher risk of developing heart disease and a 19 percent higher risk of developing diabetes. In contrast, eating unprocessed red meat was not associated with risk of developing heart disease or diabetes. Too few studies evaluated the relationship between eating meat and risk of stroke to enable the researchers to draw any conclusions.“Although cause-and-effect cannot be proven by these types of long-term observational studies, all of these studies adjusted for other risk factors, which may have been different between people who were eating more versus less meats,” said Mozaffarian. “Also, the lifestyle factors associated with eating unprocessed red meats and processed meats were similar, but only processed meats were linked to higher risk.”“When we looked at average nutrients in unprocessed red and processed meats eaten in the United States, we found that they contained similar average amounts of saturated fat and cholesterol. In contrast, processed meats contained, on average, four times more sodium and 50 percent more nitrate preservatives,” said Micha. “This suggests that differences in salt and preservatives, rather than fats, might explain the higher risk of heart disease and diabetes seen with processed meats, but not with unprocessed red meats.”Dietary sodium (salt) is known to increase blood pressure, a strong risk factor for heart disease. In animal experiments, nitrate preservatives can promote atherosclerosis and reduce glucose tolerance, effects which could increase risk of heart disease and diabetes.Given the differences in health risks seen with eating processed meats versus unprocessed red meats, these findings suggest that these types of meats should be studied separately in future research for health effects, including cancer, the authors said. For example, higher intake of total meat and processed meat has been associated with higher risk of colorectal cancer, but unprocessed red meat has not been separately evaluated. The authors also suggest that more research is needed into which factors (especially salt and other preservatives) in meats are most important for health effects.Current efforts to update the United States government’s Dietary Guidelines for Americans, which are often a reference for other countries around the world, make these findings particularly timely, the researchers say. They recommend that dietary and policy efforts should especially focus on reducing intake of processed meat.“To lower risk of heart attacks and diabetes, people should consider which types of meats they are eating. Processed meats such as bacon, salami, sausages, hot dogs, and processed deli meats may be the most important to avoid,” said Micha. “Based on our findings, eating one serving per week or less would be associated with relatively small risk.”last_img read more

Dawn of a revolution

first_imgMicrosoft founder Bill Gates, who attended Harvard, returns to campus this weekend for a question-and-answer session as part of the launch of The Harvard Campaign. Below, author Walter Isaacson, who is writing a book about the great inventors of the digital age, recalls Gates’ formative years at Harvard.It may have been the most momentous purchase of a magazine in the history of the Out of Town News stand in Harvard Square. Paul Allen, a college dropout from Seattle, wandered into the cluttered kiosk one snowy day in December 1974 and saw that the new issue of Popular Electronics featured a home computer for hobbyists, called the Altair, that was just coming on the market. He was both exhilarated and dismayed. Although thrilled that the era of the “personal” computer seemed to have arrived, he was afraid that he was going to miss the party. Slapping down 75 cents, he grabbed the issue and trotted through the slush to the Currier House room of Bill Gates, a Harvard sophomore and fellow computer fanatic from Lakeside High School in Seattle, who had convinced Allen to drop out of college and move to Cambridge. “Hey, this thing is happening without us,” Allen declared. Gates began to rock back and forth, as he often did during moments of intensity. When he finished the article, he realized that Allen was right. For the next eight weeks, the two of them embarked on a frenzy of code writing that would change the nature of the computer business.What Gates and Allen set out to do, during the Christmas break of 1974 and the subsequent January reading period when Gates was supposed to be studying for exams, was to create the software for personal computers. “When Paul showed me that magazine, there was no such thing as a software industry,” Gates recalled. “We had the insight that you could create one. And we did.” Years later, reflecting on his innovations, he said, “That was the most important idea that I ever had.”In high school, Gates had formed the Lakeside Programming Group, which made money writing computer code for companies in the Pacific Northwest. As a senior, he applied only to three colleges — Harvard, Yale, and Princeton — and he took different approaches to each. “I was born to apply for college,” he said, fully aware of his ability to ace meritocratic processes. For Yale he cast himself as an aspiring political type and emphasized the month he had spent in Washington as a congressional page. For Princeton, he focused only on his desire to be a computer engineer. And for Harvard, he said his passion was math. He had also considered MIT, but at the last moment blew off the interview to play pinball. He was accepted to all three, and chose Harvard. “There are going to be some guys at Harvard who are smarter than you,” Allen warned him. Gates replied, “ ‘No way! No way!’ ”When he was asked to describe the types of roommates he preferred, Gates asked for an African American and an international student. He was assigned to Wigglesworth Hall with Sam Znaimer, a science geek from a family of poor Jewish refugees in Montreal, and Jim Jenkins, a black student from Chattanooga, Tenn. Znaimer, who had never known a privileged WASP before, found Gates friendly but weirdly fascinating. He marveled as Gates spent several nights filling out various federal and state tax forms for the revenues of his high school programming firm, and was astounded by the intensity of his study schedule. “His habit was to do 36 hours or more at a stretch, collapse for 10 hours, then go out, get a pizza, and go back at it,” he recalled. “And if that meant he was starting again at 3 in the morning, so be it.” When working hard, Gates would rock back and forth. Then he would grab Znaimer for a frenzy of playing Pong, the Atari video game, in the dorm lounge, or Spacewar!, a legendary game invented at MIT, on one of the mainframes in Harvard’s computer lab.After their freshman year, Bill Gates and Andy Braiterman, who was better at math than Gates, decided to room together. They were assigned to Currier House, which Gates loved. Jon Chase/Harvard Staff PhotographerThe lab was named after Harvard’s computer science pioneer Howard Aiken, who had invented an electromechanical computer known as the Mark I, which now sits in the lobby of the Science Center. The Aiken Lab housed one of Gates’s favorite machines: a PDP-10 from Digital Equipment Co. It had been destined for use in Vietnam but was reassigned to Harvard to assist military-funded research there. To avoid sparking an antiwar protest, it was smuggled into the lab early one Sunday morning in 1969. There were also a slew of PDP-1 computers on which to play Spacewar! For his freshman computer project, Gates linked the PDP-10 and a PDP-1 to create a video baseball game. “The logic was on the PDP-10, but I sent it down to the PDP-1 because I used the same display as Spacewar!, a line-drawing display which you don’t see anymore,” said Gates.Allen’s warning to Gates that he would not always be the smartest kid in class turned out to be true. There was a freshman who lived upstairs from him in Wigglesworth who was better at math, Andy Braiterman from Baltimore. They would wrestle with Math 55 problem sets all night in Braiterman’s room, eating pizza. “Bill was intense,” Braiterman remembered, both about math and poker. He was also “a good arguer.” Gates was particularly forceful in asserting that soon everyone would have a home computer that could be used for calling up books and other information. He and Braiterman decided to room together, and they were assigned to Currier House, which Gates loved.Gates decided to major in applied math rather than pure math. “I met several people in the math department who were quite a bit better than I was in math,” he said. “It changed my mind about going into math.” He was able to make a small mark on the field of applied math. In a class taught by computer scientist Harry Lewis, he was introduced to a classic problem:The chef in our place is sloppy, and when he prepares a stack of pancakes they come out all different sizes. Therefore, when I deliver them to a customer, on the way to the table I rearrange them (so that the smallest winds up on top, and so on, down to the largest at the bottom) by grabbing several from the top and flipping them over, repeating this (varying the number I flip) as many times as necessary. If there are n pancakes, what is the maximum number of flips (as a function f(n) of n) that I will ever have to use to rearrange them?The answer required coming up with a good algorithm, just as any computer program did. “I posed it in class, and then I went on,” Lewis recalled. “And a day or two later, this smart sophomore comes into my office and explains that he’s got a five-thirds N algorithm.” In other words, Gates had figured out a way to do it with five-thirds flips per the number of pancakes in the stack. “It involved a complicated case analysis of what exactly the configuration of the top few pancakes might look like,” Lewis recalled. “It was quite clever.” A teaching assistant in the class, Christos Papadimitriou, later published the solution in a scholarly paper co-authored with Gates.Gates developed a rebellious academic pattern: He would not go to the lectures for any course in which he was enrolled, but he would audit classes that he was not taking. He followed this rule carefully. “By my sophomore year, I was auditing classes that met at the same time as my actual classes just to make sure I’d never make a mistake,” he recalled. “So I was this complete rejectionist.”He also took up poker with a vengeance. The games would last all night in one of the common rooms of Currier House, which became known as the Poker Room. His game of choice was Seven Card Stud, high low. A thousand dollars or more could be won or lost per night. Gates was better at assessing the cards than in reading the thoughts of his fellow players. “Bill had a monomaniacal quality,” Braiterman said. “He would focus on something and really stick with it.” At one point he gave Paul Allen his checkbook to try to stop himself from squandering more money, but he soon demanded it back. “He was getting some costly lessons in bluffing,” said Allen. “He’d win $300 one night and lose $600 the next. As Bill dropped thousands that fall, he kept telling me, ‘I’m getting better.’ ”In a graduate-level Economics 2010 class taught by Michael Spence, Gates met a student who lived down the hall from him at Currier House. Steve Ballmer was very different from Gates on the surface. He was big, boisterous, and gregarious, the type of campus enthusiast who seemed to join or lead every organization. He was in the Hasty Pudding Club, the manager of the football team, the publisher of the Advocate, and the advertising manager of the Crimson. What bound the two was their shared super-intensity. They would talk and argue and study together at high volume, each of them rocking back and forth. Then they would go see movies together. “We went and saw ‘Singin’ in the Rain’ and ‘A Clockwork Orange,’ which are only connected by the use of a common song,” said Gates. “And then we got to be super-good friends.”Such was Gates’s life at Harvard when it was suddenly changed, halfway through his sophomore year, by Allen’s arrival at his Currier House room with his newly purchased copy of Popular Electronics featuring the Altair on the cover. Allen’s rallying cry — “Hey, this thing is happening without us” — jolted Gates into action.Gates and Allen set out to write some software that would make it possible for hobbyists to create their own programs on the Altair. Specifically, they decided to write an interpreter for the programming language known as BASIC that would run on the Altair’s Intel 8080 microprocessor. It would become the first commercial native high-level programming language for a microprocessor. In other words, it would launch the personal computer software industry.They wrote a letter to MITS, the fledgling Albuquerque company that made the Altair, claiming that they had created a BASIC language interpreter that could run on the 8080. “We are interested in selling copies of this software to hobbyists through you.” In reality, they did not yet have any software. But they knew they could scramble and write it if MITS expressed interest.When they did not hear back, they decided to call. Gates suggested that Allen place the call, because he was older. “No, you should do it; you’re better at this kind of thing,” Allen argued. They came up with a compromise: Gates would call, disguising his squeaky voice, but he would use the name Paul Allen, because they knew it would be Allen who would fly out to Albuquerque if they got lucky. “I had my beard going and at least looked like an adult, while Bill still could pass for a high school sophomore,” recalled Allen.When the founder of MITS, Ed Roberts, answered the phone, Gates put on a deep voice and said, “This is Paul Allen in Boston. We’ve got a BASIC for the Altair that’s just about finished, and we’d like to come out and show it to you.” Roberts replied that he had gotten many such calls. The first person to walk through his door in Albuquerque with a working BASIC would get the contract. Gates turned to Allen and exulted, “God, we gotta get going on this!’”Because they did not have an Altair to work on, Allen had to emulate one on the PDP-10 mainframe at the Aiken Lab. So they bought a manual for the 8080 microprocessor and within weeks Allen had the simulator and other development tools ready.Meanwhile, Gates was furiously writing the BASIC interpreter code on yellow legal pads. “I can still see him alternately pacing and rocking for long periods before jotting on a yellow legal pad, his fingers stained from a rainbow of felt-tip pens,” Allen recalled. “Once my simulator was in place and he was able to use the PDP-10, Bill moved to a terminal and peered at his legal pad as he rocked. Then he’d type a flurry of code with those strange hand positions of his, and repeat. He could go like that for hours at a stretch.”One night they were having dinner at Currier House, sitting at the table with the other math geeks, and they began complaining about facing the tedious task of writing the floating-point math routines, which would give the program the ability to deal with both very small and very large numbers in scientific notation. A curly-haired kid from Milwaukee named Monte Davidoff piped up, “I’ve written those types of routines.” It was the benefit of being at Harvard. Gates and Allen began peppering him with questions about his capacity to handle floating-point code. Satisfied they knew what he was talking about, they brought him to Gates’s room and negotiated a fee of $400 for his work. He became the third member of the team, and would eventually earn a lot more.Gates ignored the exam cramming he was supposed to be doing and even stopped playing poker. For eight weeks, he, Allen, and Davidoff holed up day and night at the Aiken lab making history. Occasionally they would break for dinner at Harvard House of Pizza or at Aku Aku, an ersatz Polynesian restaurant. In the wee hours of the morning, Gates would sometimes fall asleep at the terminal. “He’d be in the middle of a line of code when he’d gradually tilt forward until his nose touched the keyboard,” Allen said. “After dozing an hour or two, he’d open his eyes, squint at the screen, blink twice, and resume precisely where he’d left off — a prodigious feat of concentration.”They would scribble away at their notepads, competing to see who could execute a subroutine in the fewest lines. “I can do it in nine,” one would shout. Another would shoot back, “Well, I can do it in five!” As Allen noted, “We knew that each byte saved would leave that much more room for users to add to their applications.” The goal was to get the program into less than the 4K of memory that an enhanced Altair would have, so there would be a little room left over for the consumer to use. (A 16GB smartphone has four million times that memory.) At night they would fan out the printouts onto the floor and search for ways to make it more elegant and compact. By late February 1975, after eight weeks of intense coding, they got it down, brilliantly, into 3.2K. “It wasn’t a question of whether I could write the program, but rather a question of whether I could squeeze it into under 4K and make it super fast,” said Gates. “It was the coolest program I ever wrote.” Gates checked it for errors one last time, then commanded the Aiken lab’s PDP-10 to spew out a punch-tape of it so Allen could take it down to Albuquerque.When Allen arrived at MITS, he toggled the switches on the Altair and then waited 10 minutes for the tape reader to load in the code. Ed Roberts and his colleagues exchanged amused glances, already suspecting that the show would be a fiasco. But then the Teletype clacked to life. “MEMORY SIZE?” it asked. “Hey, it typed something!” shouted one of the MITS team. Allen was happily flabbergasted. He typed in the answer: 7168. The Altair responded: “OK.” Allen typed in: “PRINT 2+2”. It was the simplest of all questions, but it would test not only Gates’s coding but also Davidoff’s floating-point math routines. The Altair responded: “4.”Up until then, Roberts had been watching quietly. He had taken his failing company further into debt on the wild surmise that he could create a computer that a home hobbyist could use and afford. Now he was watching as history was made. For the first time, a software program had run on a commercially viable home computer. “Oh my God,” he shouted. “It printed ‘4’!”Rogers invited Allen into his office and agreed to license the BASIC interpreter for inclusion on all Altair machines. “I couldn’t stop grinning,” Allen recalled. As soon as he got back to his hotel, Allen called Gates at Harvard. They were officially in business. When Allen arrived back in Cambridge, bringing with him a working Altair to install in Gates’s Currier House room, they went out to celebrate. Gates had his usual, a Shirley Temple: ginger ale with maraschino cherry juice.A month later, Roberts offered Allen a fulltime job at MITS as director of software. Gates decided to stay at Harvard, at least for the time being. There he endured what has become a rite of passage, amusing only in retrospect, for many of Harvard’s most successful students: being hauled before the dreaded and then-secretive Administrative Board for a disciplinary process, known as being “Ad Boarded.” Gates’s case arose when auditors from the Defense Department decided to check the use of the PDP-10 that it was funding in Harvard’s Aiken lab. They discovered that one sophomore — W.H. Gates — was using most of the time. After much fretting, Gates prepared a paper defending himself and describing how he had created a version of BASIC using the PDP-10 as a simulator. He ended up being exonerated for his use of the machine, but he was “admonished” for allowing a non-student, Allen, to log on with his password. He accepted that minor reprimand and agreed to put his early version of the BASIC interpreter (but not the refined one he and Allen were by then working on) into the public domain.By that time, Gates was focusing more on his software partnership with Allen than his coursework at Harvard. He finished his sophomore year that spring of 1975, but then flew down to Albuquerque for the summer and decided to stay there rather than returning for the first semester of his junior year that fall. He went back to Harvard for two more semesters, in the spring and fall of 1976, but then left Harvard for good, two semesters shy of graduating. In June 2007, when he returned to Harvard to get an honorary degree, he began his speech by directing a comment to his father in the audience. “I’ve been waiting more than 30 years to say this: Dad, I always told you I’d come back and get my degree.”Walter Isaacson has written biographies of Steve Jobs, Albert Einstein, and Benjamin Franklin. He is a Harvard Overseer.last_img read more