IMDRF Releases Final UDI Guidance, Requirements for Medtech Software

Medical device companies must include all core data elements for the unique device identification database except those marked “optional,” according to the International Medical Device Regulators Forum. Data elements marked “if applicable” are mandatory in the UDID if the information appears on the product label, IMDRF adds.

The harmonized guidance, issued last month, lists 25 core data ele-ments. Only two of those — additional product description and URL for additional information, such as electronic IFU — are optional. Nine of the data elements fall into the “if applicable” category.

Data for device identifiers must be available in the database at the time the product is launched. This provision, also contained

Court Hears Conflict Minerals Argument As Late-May Disclosure Deadline Nears

A recent appeals court hearing on the Securities and Exchange Commission’s conflict minerals disclosure rule provided no immedi-ate relief for manufacturers — though the line of questioning sug-gested some judges were sympathetic to industry’s free speech argu-ment against the rule.

The rule, which took effect in November 2012, requires device-makers and other manufacturers to publicly disclose if their prod-ucts include any tantalum, tin, gold or tungsten from the Democratic Republic of the Congo, Central African Republic, South Sudan, Zambia or Angola. It was mandated as part of the 2010 Dodd-Frank Wall Street reform law to help consumers avoid minerals obtained from areas gripped by violence.

The first reports under the rule are due May 31.

The National Association of Manufacturers sued the SEC last year, hoping to block enforcement of the rule. The NAM claimed that the

Issue No. 409February 2014

St. Jude makes progress on warning, sees CRM growth in fourth quarter .......Page 2

Chinese authorities set new GMP guidelines for daily site inspectors ..........Page 2

Racer Technology warned over CAPA, supplier proce-dures ........................Page 3

FDA warns Philips Health-care for failure to report recall ........................Page 3

American Aesthetics warned for purchasing pro-cedure slip ups .........Page 4

Form 483 Insider: Epimed … CareFusion … Baxter … Materialise ...............Page 5

Invacare focusing on com-plaints to wrap up consent decree .......................Page 7

Incoming inspection issues cited in warning to Finnish devicemaker .............Page 7

INsIde thIs Issue

(See Conflict, Page 8)

(See UDI, Page 8)

the gmp letter February 2014Page 2

Chinese Authorities Set New GMP Guidelines for Daily Site Inspectors

Chinese inspectors will focus their reviews on production technologies, raw materials, adverse event reports and a company’s past inspection track record when they conduct quality inspections.

The areas of emphasis were spelled out in a guideline the China Food and Drug Administra-tion released Jan. 13, advising daily-site super-visors on inspection processes. It also advises inspectors to review current good manufacturing practice guidelines when conducting inspections.

The guideline directs supervisors to sub-mit on-site inspection materials, corporate cor-rective action plans and follow-up examination materials promptly to the relevant CFDA office. Open communication between corporate man-agement and daily-site inspectors is encouraged to ensure information is accurately disseminated when necessary.

Seth Goldenberg, a global medical research scientist at NAMSA, a regulatory and compliance research group, says the CFDA “released the guidance for the inspectors for industry to know what to expect when they show up. They still have to comply with the GMP, but it helps clarify the process.” — Nick Otto

St. Jude Makes Progress on Warning, Sees CRM Growth in Fourth Quarter

St. Jude’s Sylmar, Calif., plant, which makes most of its CRM products, should soon emerge from an FDA warning letter, CEO Dan Starks said on the company’s earnings call last month.

“We have reported to FDA that our remedi-ation at our Sylmar facility is complete and that our Sylmar facility is ready for reinspection,” he said.

The warning letter, which was issued in December 2012, cited numerous procedural problems at the Sylmar manufacturing plant (GMP, February). The company was already facing questions about the safety of its Durata leads, following a 2011 recall of a similar prod-uct, Riata.

Larry Biegelsen, a senior analyst at Wells Fargo Securities, believes those worries may be behind St. Jude. In addition to the company’s progress with the FDA, he said current clinical data on updated versions of the Durata ICD lead “continues to be very encouraging.”

Business is on the upswing for St. Jude Medi-cal’s once-beleaguered cardiac rhythm manage-ment division, which experienced strong growth in the 2013 fourth quarter.

The company’s CRM sector had $705 million in sales during the quarter, more than $30 million over Wall Street expectations. Sales of implant-able cardioverter defibrillators were up 5 percent to $442 million and pacemakers snared $263 mil-lion, a 4 percent gain.

“We estimate that St. Jude Medical gained approximately 50 basis points of global CRM market share during the quarter,” Starks said.

The company also saw growth in its atrial fibrillation, cardiovascular and neuromodula-tion divisions during the quarter. Overall com-pany sales for the quarter were $1.42 billion, a 4 percent increase from the prior fourth quarter.

Full-year sales were essentially flat — $5.501 bil-lion versus $5.503 in 2012.

St. Jude’s 2014 growth will be led by Euro-pean launches of the Nanostim leadless pace-maker and Endosense ablation catheters, as well as an expanded rollout of the spinal modulation dorsal root ganglion stimulation technology in the region, Stark told investors.

The company expects to complete its acquisi-tion of CardioMEMS before midyear, accelerat-ing the vascular products division’s growth and pace. CardioMEMS makes the Champion heart failure monitoring system, which was recom-mended for approval by an FDA advisory panel last fall. — Elizabeth Orr

the gmp letterFebruary 2014 Page 3

Racer Technology Warned Over CAPA, Supplier Procedures

Racer Technology, a Singapore maker of cochlear implant accessories, expressed confu-sion about the term “device history record” dur-ing a recent FDA inspection, drawing a warning letter from the agency.

“The investigator referred your firm to 21 CFR 820.184 and read the entire section to your firm,” according to the Dec. 12 letter posted recently online. “Your firm then confirmed that it was unaware of this requirement.”

The FDA also rapped the company for its purchasing procedure, which did not adequately define supplier quality control. The procedure out-lines quality reviews and a grading scale of poor, average or good; however, “there are no defined requirements for the sources of quality data that are to be reviewed to make this determination, nor are there any defined levels of what constitutes a poor, average, or good rating,” the letter states.

Meanwhile, the company’s supplier/vendor quality audit procedure gives requirements for periodic auditing of critical component suppliers, but when the FDA investigator asked which com-ponents were critical, Racer didn’t know.

Racer’s CAPA procedure lacks requirements for analyzing quality data, using appropriate sta-tistical methodology and ensuring verification or validation before CAPAs are implemented, the warning letter continues. And the procedure does not require documentation for all CAPA activities.

During the June 3-6 inspection, the FDA investigator reviewed several sets of manufac-turing and test records for three lots of earhook devices and battery charger accessory devices. The records did not identify equipment used dur-ing testing and did not identify the unit being tested, the letter says.

Flow diagrams that outline Racer’s complaint handling procedures lack requirements to ensure timely complaint processing, documentation and evaluation for MDR reportability, the letter adds.

When complaints are not investigated, the dia-grams don’t instruct employees to record why there was no investigation and the name of the person who decided not to investigate.

Racer could not be reached for comment by press time. The warning letter is available at www.fdanews.com/ext/resources/files/01/01-02-14-Racer.pdf. — April Hollis

FDA Warns Philips Healthcare For Failure to Report Recall

Philips Healthcare’s failure to report a recall to the FDA earned the company an FDA warning letter.

According to the Dec. 20 letter recently posted online, Philips launched a recall to replace the main control board on a component of Inner-Cool RTx Endovascular Systems in certain lots from January 2012. The recall was initiated due to reports of low patient temperature readings that could cause the console to deliver more heat to the patient than was needed, the letter says.

However, the FDA was never notified of the recall, a deviation from agency requirements that devicemakers alert the FDA to device correction and removal actions within 10 days of their ini-tiation. The agency discovered the problem dur-ing a July 29-31, 2013, inspection of Philips’ San Diego plant.

While Philips responded to the agency’s orig-inal postinspection Form 483, the response was deemed inadequate because the company “did not address the above referenced corrections and removals, and did not provide any information to our office regarding the above events,” the warn-ing letter says.

The FDA instructed Philips to provide the required information to specific recall coordina-tors within the agency’s San Diego field office, which issued the document.

Philips could not be reached for comment.

View the warning letter at www.fdanews.com/ext/resources/files/01/01-20-14-Philips.pdf. — Elizabeth Orr

the gmp letter February 2014Page 4

American Aesthetics Warned for Purchasing Procedure Slip Ups

American Aesthetics Medical Supply, a Dal-las-based maker of microdermabrasion systems and crystals, lacks appropriate procedures for its suppliers and receipt of incoming ingredients, according to an FDA warning letter.

A March 14-19 inspection by the FDA’s Dal-las district office found the company had no writ-ten purchasing and control procedures for its Microderma S-100 microdermabrasion system and Youth 1 Microcurrent with LED light ther-apy, the letter says. “Additionally, your firm has not evaluated and documented the ability of the manufacturers of these products to meet specified requirements, including quality requirements.”

American Aesthetics also did not have writ-ten procedures on how its products should be received and inspected, nor could it provide records of testing. And the company was lack-ing written procedures for several other quality system requirements, including medical device reporting and complaint handling.

“A review of your firm’s sales invoices showed a number of the Microderma S-100 microderm-abrasion devices were serviced due to loss of suc-tion or vacuum and microdermabrasion crystals not flowing properly,” the letter says. “Although your firm replaced parts during servicing, it did not document evaluation or investigation of the probable causes of these complaints.”

Meanwhile, American Aesthetics did not have written procedures for the servicing needed for the Microderma S-100 microdermabrasion and Youth 1 Microcurrent with LED light therapy devices. The company should have had procedures for how they are to be serviced, repaired or returned to manu-facturers, along with any test results that should be documented after servicing, the letter says.

According to the letter, the company had not conducted any quality audits and has no records of employee training and several other procedures.

American Aesthetics did not respond to a request for comment by press time. The warning let-ter is available at www.fdanews.com/ext/resources/files/01/01-21-13-American.pdf. — April Hollis

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the gmp letterFebruary 2014 Page 5

CareFusion Investigation on Debris Falls Short: 483

Investigation failures related to debris/partic-ulate matter associated with CareFusion’s Denver Ascites Shunt and percutaneous access kit led to a recent Form 483.

The devicemaker learned of the issue in August 2011, but the FDA’s review of its CAPA found the investigation was inadequate, including failure to analyze the particulate matter/debris on the shunts and inside the peritoneal catheter/tubing. Such an analysis should have been conducted to identify the composition of the debris to help determine the source, according to the Nov. 5 form. The device’s labeling noted presence of the debris as a significant safety and effectiveness concern, the form notes.

CareFusion was also rapped for receiving 32 complaints on the debris from Aug. 25, 2011, to September 2013, without making an MDR report to the FDA. On a separate complaint into a baby’s penis being cut due to improperly rounded out scis-sors, CareFusion failed to eliminate device failure as a contributing factor. The company also failed to determine whether its supplier manufactured the scissors according to specification, the form says.

Another observation noted that quality sys-tem questions on the Supplier Self Audit Ques-tionnaire for two Level I suppliers were not com-pleted by the suppliers but were reviewed and approved by CareFusion without any follow-up.

CareFusion did not respond to a request for comment by press time. The Form 483 is available at www.fdanews.com/ext/resources/files/02/02-03-14-Carefusion.pdf.

Materialise Slow on Calibrations, FDA Inspection Report Shows

Materialise USA had several calibrations on its preventive maintenance schedule, but did not perform them within seven days of the due date or document the reason for the delay, according to an FDA Form 483.

These included scan calibrations for the com-pany’s optical scanner and an IR calibration for its selective laser sintering machine, for which results were not recorded, according to the Dec. 10 form.

Meanwhile, there was no documentation of the review and revalidation of the company’s selective laser sintering machines after it made changes to the original process parameters established during installation or performance qualifications.

The company also replaced a label for a lot of its Class II patient specific CR-Flex pin guides, which were shipped to a partner. However, man-agement stated there was no record with justifica-tion for not reporting this to the FDA.

The company is on track addressing the observations and sending regular responses to the FDA, it said. The Form 483 is available at www.fdanews.com/ext/resources/files/02/02-03-14-Materialise.pdf.

Epimed Slips on Procedures, Design Validation Land 483

Epimed remanufactured products in response to complaints without established production and process control procedures, according to a Nov. 6 Form 483.

Moreover, the company updated a procedure, changing the action limit for extension set bond strength, but did not update the design specifica-tions in the extension sets design file, the form says. It also did not carry the specification change through the entire design review process to make sure it does not adversely affect the device. The source for the change was not adequately docu-mented, the Form 483 adds.

Design Validation Slip-Ups

Epimed’s design validation procedure does not ensure it identifies all deviations from accep-tance criteria and corrects them before the approval of validation data, the form continues.

form 483 INsIder

(See Form 483 Insider, Page 6)

the gmp letter February 2014Page 6

For example, the design validation for a cath-eter was completed with a missing datapoint for shear resistance, the form says. “The acceptance criteria of the validation required an average score of [a redacted amount] or higher on this crite-ria (and all others) and also stated any individual scores of [a redacted amount] must be reviewed to determine if the failure affects the safety or effec-tiveness of the device,” the form says. “The miss-ing datapoint for ‘shear resistance’ of the catheter was not identified during validation data review, compilation of the summary report or conclusion.”

The validation was approved without the deviation being identified or corrected. Further, the design validation did not meet acceptance criteria, the form adds. The design review con-ducted after the validation did not spot the lack-ing data/deviation in the design validation.

Epimed did not respond to a request for com-ment by press time. The Form 483 is available at www.fdanews.com/ext/resources/files/02/02-03-14-Epimed.pdf.

Baxter 483 Notes Miscalculation Of Risk With Software Error

Baxter has received an FDA Form 483 for miscalculating the risk of a product issue.

The company initiated a CAPA after cus-tomer complaints about a “mismatch between the patient and the [total parenteral nutrition] ingre-dient order.” The company’s Abacus TPN Cal-culation Software assigned the incorrect formula to patients, according to the Oct. 30 form posted recently online.

Baxter decided to provide revised software to new customers, but determined that field cor-rections were unnecessary because the risk was acceptable. However, the FDA investigator found Baxter miscalculated the risk and failed to con-sider the dangers of “an over-delivery of ingredi-ents” to patients who receive the wrong solution.

The company did not respond to a request for comment by press time. The Form 483 is at www.fdanews.com/ext/resources/files/02/02-03-14-Baxter.pdf.

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Form 483 Insider, from Page 5

the gmp letterFebruary 2014 Page 7

Invacare Focusing on Complaints To Wrap Up Consent Decree

Invacare says it has made “significant prog-ress” on its FDA consent decree, but must do some additional work on its complaint system before an independent auditor provides final cer-tification to the agency.

The company is working on an action plan to address observations from the auditor’s third audit and has added some contractors to help whittle down a complaint backlog, said Lara Mahoney, chief of investor relations. The third-party con-tractor will revisit Invacare in February, and the devicemaker hopes to have an estimate of the remaining backlog time soon after that. “Every day we’re working through it,” she told GMP.

The first two audits required by the decree covered equipment, process validation proce-dures and design control systems at the com-pany’s Taylor Street and Elyria, Ohio, manufac-turing facilities. The FDA deemed the results of those audits to be acceptable.

Invacare was placed under the consent decree in December 2012, agreeing to stop making and distributing manual and power wheelchairs until multiple good manufacturing process violations are corrected (GMP, January 2012).

The company has since overhauled its com-plaint handling system and now requires all com-plaint data to flow through one system, which led to the backlog. Recently, Invacare disclosed that it has been closing significantly more complaints than are opened under the new system, which was launched several months ago, and Mahoney acknowledged that complaint data are temporarily coming in faster than the company can train new employees to investigate the reports. The additional contractors will help the company catch up, she said.

Once the auditor’s final certification report and Invacare’s compliance report are submitted, the FDA will inspect the corporate and Taylor Street facilities. Pending a successful inspection outcome, the agency will provide written notifi-cation that Invacare can resume full operations.

Invacare said it doesn’t have an estimated time for completing the final certification report, but will update investors on its progress in an early February earnings release.

Earlier this year, Invacare laid off 143 employees as a result of the decree and manu-facturing hiatus (GMP, January). Mahoney said the company will reevaluate its staffing when it resumes full operations. “Certainly, the goal will be, as we get back to full operations, that we would be able to rehire some of those employ-ees,” she said. — April Hollis

Incoming Inspection Issues Cited In Warning to Finnish Devicemaker

Mega Electronics, maker of the FemiS-can Home Trainer incontinence device and the ME6000 biomonitor device, received an FDA warning letter for incoming inspection shortfalls and other quality issues.

During an Aug. 26-29 inspection of its Kuo-pio, Finland, plant, the devicemaker did not have a rationale for the sample size it chose for incom-ing inspections. The company also does not record the incoming inspection results of its circuit boards, according to the Jan. 9 letter posted online recently.

The warning letter goes on to cite Mega Elec-tronics’ corrective and preventive action pro-cedures for lacking requirements for analyzing quality data to identify the root cause of prob-lems. And the company’s CAPA form did not have control information to ensure it is the cor-rect, approved version, the letter says. Mega Elec-tronics did not maintain complaint files or proce-dures, and its customer feedback form does not provide criteria for evaluating a complaint for MDR reportability, the letter adds.

The FDA also chided the devicemaker for making a change in components without doc-umenting, verifying or validating the change before implementation.

The company did not respond to a request for comment by press time. The warning letter is at www.fdanews.com/ext/resources/files/01/01-21-13-Mega.pdf. — April Hollis

the gmp letter February 2014Page 8

in the FDA’s UDI final rule (GMP, January), has drawn criticism from industry, which wor-ries it could delay market entry of new devices. The guidance finalizes a draft issued last spring (GMP, May 2013).

To achieve global harmonization, regulators must implement UDI systems “without regional or national differences,” IMDRF stresses. To this end, countries should not modify the UDID core data elements and submissions should be via the Health Level Seven International (HL7) structured product label and web-based interface, the guidance says.

Further, a UDI applied to a device anywhere in the world should be recognized globally and meet the UDI requirements of any markets where the product is sold, the document adds.

In discussing UDI’s benefits, the final guid-ance says it will facilitate the “unambiguous identification” of devices through distribution and use — strengthening the draft’s reference of “adequate identification.” The guidance also expands on adverse event reporting to include field safety correction actions.

Separately, IMDRF finalized a set of harmo-nized definitions on device software. The docu-ment defines “software as a medical device,” or SaMD, as “software intended to be used for one or more medical purposes that perform these pur-poses without being part of a hardware medical device.” It also clarifies the various tasks that med-ical software may perform and changes to SaMD.

The guidances follow on the heels of four other final documents, including requirements for auditing organizations that wish to participate in the Medical Device Single Audit Program.

View the UDI guidance at www.fdanews.com/ext/resources/files/12/01-14-IMDRF_UDI.pdf. The guidance on SaMD is at www.fdanews.com/ext/resources/files/12/01-14-IMDRF_SaMD.pdf. — Meg Bryant

UDI, from Page 1

Conflict, from Page 1

Reporters: Nick Otto, Johnathan Rickman, Elizabeth Orr, Ferdous Al-Faruque, Robert King, Lena Freund, Melissa Winn

President: Cynthia Carter; Content Director: Dan Landrigan; Executive Editor: Meg Bryant

Copyright © 2014 by Washington Business Information Inc. All rights reserved. the gmp letter (ISSN 0196-626X), an executive briefing on FDA enforcement and quality systems requirements for medical devices and diagnostics, is published monthly, 12 issues, for $985. Photocopying or reproducing in any form, including electronic or facsimile transmission, scanning or electronic storage is a violation of federal copyright law and is strictly prohibited without the publisher’s express written permission. Subscribers registered with the Copyright Clearance Center (CCC) may reproduce articles for internal use only. For more information, contact CCC at www.copyright.com or call (978) 750-8400.

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required disclosures trampled manufacturers’ right to free speech. The case is now before the U.S. Court of Appeals for the District of Columbia.

Sources who attended the hearing said the three-judge panel’s line of questioning appeared to favor the NAM, with two GOP-appointed judges wondering if the disclosures amounted to “compelled speech.”

Ron Oleynik, a partner at Holland & Knight, said the court may ask the SEC to change the reporting requirement due to the free speech concerns. But devicemakers shouldn’t pin their hopes on a possible reprieve with May’s report-ing deadline looming, he warned.

“Certainly [the judges’] line of questioning seemed in some respects downright harsh for SEC and supporters, but judges sometimes sur-prise us when it actually comes time to rule,” he said. “It’s important the message be put out there to companies that they need to be moving on this now. It’s almost too late.” — Elizabeth Orr

Implementing Risk-Based Verification and Validation

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DAY TWO

8:00 A.M. – 8:30 A.M. ConTinenTAL BreAkFAsT/ neTworkinG

8:30 a.m. – 12:00 p.m.• inTerACTiVe eXerCise! A quick

review — Discuss what you and your team-mates found useful from the previous day and ways you can apply the ideas.

• Procedures as tools to support performance

• inTerACTiVe eXerCise! The amount of detail in a procedure

¤ WaystopromoteconsistentperformanceusinganSOP

• Case studies: what could we do?

• inTerACTiVe eXerCise! identifying integrated approaches to solve problems using supplied cases or “bring-your-own” — A chance to apply the models and find could have caused or contributed to the problem. (if you have a problem you are working on, bring a “disguised” version of it as a case your team can consider.)

12:00 P.M. – 1:00 P.M. LUnCH

1:00 p.m. – 3:30 p.m.• Assessment and evaluation — how can

you measure success?¤ Whatcanyourqualitysystemtellyouabouttheeffectivenessofyourlearningprogram?

¤ inTerACTiVe eXerCise! what would evaluation and assessment look like for this course? — Come up with ways to evaluate the course and assess individual learning – models that you can take back and use

• Alignment: Making sure all the pieces fit¤ Whatis“alignment?”Whyisitsoimportant?

• evaluating and enhancing YoUr learning program and investigation program

¤ Whatmetricsareyouusing?¤ inTerACTiVe eXerCise! what are

some ways they can be improved? — Create an action plan that you can use to improve your learning and performance program.

¤ Makingthecasetomanagementtosupportandenhancetraining,improveinvestigationsanddrivedownhumanerrors

3:30 P.M. – 4:00 P.M. sUMMArY/CLosinG

worksHoP AGenDA

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Visitwww.BeyondGMPTraining.comorcall(888)838-5578

Beyond GMP Training:Improving Human Performance and Reducing Errors

March19-20,2014•DoubletreeBethesdaHotel•Bethesda,MD

• Complianceofficers• Consultants/serviceproviders• Engineeringanddesigncontrolteams

• Executivemanagement• Managers• Manufacturingdirectorsandsupervisors

• Procedurewriters• PharmaceuticalandcGMPauditors

• QA/QCpersonnel• R&Dstaff• CAPAspecialists• Trainingpersonnel• Instructionaldesignersandtechnologists

WHOSHOULDATTEND

YoUr eXPerT insTrUCTor

• Examplesoftrainingandinvestigation-related483citationsandWarningLetters• Modelsusedtodeterminecontributorsto“humanerror”• Sampleevaluationsandassessments• ChecklistforevaluatingeLearningcourses• Recommendedresources

"It's obvious James has a lot of experience and knowledge on the subject. His approach makes it easy to respond and share information. Great job, James!"

ChristineKoenig,Manager,QACompliance,AlconSurgical

“I really enjoyed and feel that I Learned a great deal from the instructor, Jim Vesper, he has an engaging quality especially when describing real-life

stories when reinforcing a training concept.”MonicaMacInnis,SeniorQualitySystemsTrainer/Auditor,

FreseniusMedicalCareNorthAmerica

“A fantastic conference! The tools Jim taught will be incredibly valuable to my training department.”

IvanOdegard,GMPTrainingSpecialist,PaddockLaboratories

CoUrse MATeriALs Book

wHAT YoUr CoLLeAGUes HAVe To sAY

JAMESVESPERdesignsanddevelopsinstructionalcoursesandworkshopsforpharmaceuticalandmedicaldevicecompanies.HeestablishedandispresidentofthefirmLearningPlus,Inc.,andhashadmorethan30years’experienceinthepharmaceuticalindustry.

Mr.VesperworkedelevenyearsatEliLillyandCo.Hisfirstassignmentwasascorporateindustrialhygienist,followedbythreeyearsincorporatequalityassurance.HewasresponsibleforissuesconcerningthemanufacturingandtestingofparenteralproductsmadeatEliLillyfacilitiesandthirdpartiesworldwide.HislastassignmentatLillywasprojectleaderofGMPeducationandinstruction,establishingthedepartmentanditsmission.

Since1991,Mr.Vesperhasbeencreatinginnovativeinstructionaltrainingproductsforthepharmaceuticalandhealthcareindustriesusingvideoandcomputertechnologiesasmoreeffectiveandefficientdeliverymedia.Workingasaconsultantwithawidevarietyofclients,hisfirmcreatesintegratedcurriculaforpersonnelandcustomizedtrainingcoursestargetedtospecificneeds.Hepresentspapersandworkshopsatvariousinternationaltechnicalandprofessionalmeetings,includingthoseoftheInternationalSocietyforPharmaceuticalEngineering,GMPTEA,PDA,PharmaceuticalSciencesGroupandPharmTech.In2001,hewasawardedthePDA’sAgallacoAwardforExcellenceinTraining.HeisalsoanadvisortotheWorldHealthOrganization’sGlobalLearningOpportunities/VaccineQualitygroup,andhasmentored,designedanddevelopedlearningprogramsthatareinuseworldwide.

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Beyond GMP Training: Improving Human Performance and Reducing ErrorsMarch19-20,2014•DoubletreeBethesdaHotel•Bethesda,MD

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