ComplianceOnline, Grand Hyatt San Francisco 345 Stockton Street, San Francisco, CA
2012-09-27
Course Description:Develop / review a company's Master Validation Plan for major cGMP deficiencies. Address the U.S. FDA's newer and tougher regulatory stance. One major failing is lack of sufficient or targeted risk-based V&V planning: - Start with a Master Validation Plan;
- Evaluate its elements against ISO 14971 and ICH Q9 for hazard analysis and product risk management;
- The Individual V&V Plan;
- V&V Project Management;
- “Risk-based” per ISO 14971, ICH Q9, and/or GAMP/JETT;
- Two key input analysis tools;
- Change control and “drawing a line in the sand”;
Course Objectives:- Understand Verification and Validation, differences and how they work together;
- Discuss recent regulatory expectations;
- How to document a “risk-based” rationale, and use it in a resource-constrained environment;
- Determine key “milestones” and “tasks” in a project;
- Locate and document key subject “inputs”;
- Compile “generic” Master and Individual Validation Plans;
- Lean the key element of a Product V&V File / Protocol;
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Invited Speakers:
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John E Lincoln
Principal, J. E. Lincoln and Associates John E. Lincoln, is Principal of J. E. Lincoln and Associates, a consulting company with over 28 years experience in U.S. FDA-regulated industries. John has worked with companies from start-up o Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).
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