Implementing a Risk-Based Internal CGMP Annual Audit Program

Structured, defined and scheduled internal CGMP compliance audits are a specific requirement of US FDA 21 CFR 820 and ISO 13485 (devices), implied in 21 CFR 210, 211 (pharma). The US FDA and the EU have stated that quality and regulatory activities are or should be “risk based”. So, how can a QMS audit program be structured and prioritized by risk? Use a 3-Phase approach to redistribute scarce resources and achieve a higher payoff in reduced liability, both civil and regulatory. How do you set-up the risk basis for subsequent action? How do you create and blend the Risk Management File findings into your annual audit plan? How is it established, maintained, formally updated, and documented?.

Areas Covered in the seminar:

• FDA's Q9 and ISO 14971:2001 -- Recent regulatory expectations
• The Internal CGMP Compliance Audit Plan -- Some a pproaches
• How to use your Risk Management Tools (per Q9 and ISO 14971)
• Risk by 21 CFR categories; ISO 13485; ISO 9001
• The cGMPs and Process / Equipment / Facility Validations
• QSIT for analysis of QMS audit’s high risk concerns
• Design Control -- expanded
• CAPA – a crucial series of risk-based lifecycle deliverables
• P&PC / HACCP – risk analysis is inherent
• Management Review – take it to the next level; competitive advantage

Who Will Benefit:

• Senior management, project leaders, internal / external consultants
• Regulatory affairs
• Quality systems personnel
• All charged with implementing, administering and supporting the QMS (Quality Management System), including new product development, regulatory submissions, initiating / overseeing company-wide quality management / planning, and desiring to utilize a risk-justified approach
• CAPA, P&PC and training personnel
• All who could be selected as a member of a CGMP Audit Team

Instructor Profile:

John E Lincoln, consultant, has successfully designed and implemented complete 21 CFR 210, 211, 820 and ISO 13485 quality management systems, which have passed FDA audits, and described in peer-reviewed technical articles and workshops, world wide. John has managed pilot production, regulatory affairs, product development, and quality audits. He has over 25 years of experience, primarily with medical devices – working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine, the Journal of cGMP Compliance, Intermountain Biomed- ical Association, and publishes a newsletter. He is a graduate of UCLA.

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