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., MS-Excel 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.

Why should you attend: Pressure is increasing on the FDA to get tougher on industry. The FDA has responded. How does that impact companies' use of COTS (commercial off the shelf) office applications software, such as spreadsheets and word processing? Just how much is required / expected? How can this be addressed? What does "science-based" mean? What are current 483 and Warning Letters indicating, and what can we learn from these? What benefits beside regulatory compliance can be achieved for a company?

Areas Covered in the Session:
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
How to Implement, Execute and Document
Proper Risk Allocation of Scarce Resources

Who Will Benefit:
Senior management in Drugs, Devices, Biologics, Dietary Supplements
QA
RA
R&D
Engineering
Production
Operations
Consultants

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 peer-reviewed 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 FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.

Price List:
Live : $245.00
Corporate live : $495.00
Recorded : $295.00

Phone: 800-447-9407
Fax: 302-288-6884

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com