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RAPS Approved Webinar


Validating Excel and Word

Date & Time: Course "Validating Excel and Word" has been pre-approved by RAPS as eligible for up to 1.5 credits towards a participant's


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RAC recertification upon full completion.

Wednesday, August 8, 2012

10:00 AM PDT | 01:00 PM EDT

Duration: 90 Minutes

Instructor: John E Lincoln

Location: Online

Price : $245.00

Instructor Profile: John E Lincoln Consultant, Medical device and Regulatory affairs,

(for one participant)

Overview: Both the U.S. FDA and the EU's MDD require companies to be proactive in reducing risk while increasing user benefits. How does this translate to common software applications programs, e.g., MSExcel and MS-Word, or similar. How can these be verified and validated? Company quality data must be more "science based". What V&V (verification and validation) planning steps are expected under the CGMPs and other guidance documents for such apps software? How can these consistently be executed? Where does ISO 14971, ICH Q9, and similar risk management systems come in? This webinar will evaluate the climate that has resulted in this call for change, and flag areas for heightened compliance in V&V planning. It will focus on eliminating major systemic validation problems. It will assist the attendee to review their existing system in light of current and anticipated changes in regulatory thinking, and in approaches to implementing necessary changes, in a realistic, risk-based approach.

Areas Covered in the Session: l l l l

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Tougher FDA and EU MDD Software V&V Expectations Key COTS Software Apps V&V Requirements Problem Areas Product, Equipment/Process, QMS and Apps Software and Part 11 V&V "Model" Realistic Limits of Apps Software V&V Suggested Approaches

John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peerreviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDAregulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA. ...more

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Who Will Benefit: l

Senior management in Drugs, Devices, Biologics, Dietary


Supplements QA RA

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R&D Engineering Production Operations Consultants

It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely benefit from this program. For more information, please contact the event coordinator. We look forward to seeing you at the webinar. Best regards, Event-coordinator GlobalCompliancePanel

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Validating Excel and Word - Webinar By GlobalCompliancePanel  

Overview: Both the U.S. FDA and the EU's MDD require companies to be proactive in reducing risk while increasing user benefits. How does thi...