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GlobalCompliancePanel, Online Training Webinar
2010-10-14
Areas Covered in the Session: - Verification or Validation - Recent regulatory expectations
- The Master Validation Plan
- Product Validation - how it differs from process / equipment V&V
- Process / Equipment / Facility Validation
- When and How to use DQ, IQ, OQ, PQ
- How to use your Risk Management Tools (per ISO 14971)
- The 11 "must have" elements of software validation
- 21 CFR Part 11 issues
- Possible "test case" formats.
Who Will Benefit: - Senior management, project leaders
- Regulatory Affairs
- Quality systems personnel
- R&D and engineering staff
- All charged with new product development, regulatory submissions, initiating / overseeing company-wide V&V planning, using a risk-justified approach
- CAPA and P&PC personnel desiring to verify proposed solutions and minimize post-production / life cycle and other costly problems.
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Organized by:
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GlobalCompliancePanel |
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Invited Speakers:
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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.
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Deadline for Abstracts:
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2010-10-18
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Registration:
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Live live online training only for one participant Price: $245.00 Corporate Live 4 to 10 participants from a single location (For multiple locations contact Customer Care)
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E-mail:
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webinars@GlobalCompliancePanel.com
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