Preparing for a U.S. FDA Audit

Structured, defined and tested CGMP systems are the start in successfully passing the "real thing". Increasingly such systems are to be risk-based, as stated by the US FDA and the EU. So, where does a company look to ensure their compliance is structured and prioritized by risk? How to create and blend the Risk Management File findings into the company’s internal and external audit plans? How is it established, maintained, formally updated, and documented? Learn from others mistakes - current FDA 483 observations. The receptionist - an auditor’s first company contact. Strategic perception. Arrangements for and facilitation of the outside audit. Training personnel on how to be "audited". Close outs "musts". Where and how to draw the "line in the sand". Responses - how, what, frequency. Avoiding Warning Letters.

Areas Covered in the seminar:

• Recent regulatory expectations.
• The Company CGMP Compliance Audit Plan.
• Most commonly missed internal audit areas.
• How to use your Risk Management Tools (per Q9 and ISO 14971)?
• Risk by 21 CFR categories; ISO 13485; ISO 9001.
• Using the FDA’s QSIT for analysis of QMS audit’s high risk concerns.
• Design control / change control expectations.
• CAPA - a major source of potential mine fields.
• P&PC and what is "auditable quality data".
• Management reviews; fine-tune and get credit action taken.

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.
• CAPA, P&PC and training personnel.
• All who are or could be a member of a CGMP Internal Audit Team.

Instructor Profile:

John E. Lincoln, consultant, has successfully designed, written and run all types of 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 27 years of experience, primarily in the medical device industry.

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