Preparing for an FDA Inspection

Areas Covered in the seminar:

• FDA authority to inspect (domestic and foreign)
• How FDA prioritizes which firms are inspected
• FDA Risk based approach and QSIT
• Types of FDA inspections
• Confidentiality of records
• What records will be reviewed
• Who participates during the inspection and what are their roles

Who Will Benefit:

• Senior Management
• Quality & Regulatory professionals
• Operations and Engineering personnel

Instructor Profile:

Sue Jacobs is the Principal Consultant for QMS Consulting, Inc. specializes in US FDA compliance with medical device quality and regulatory requirements. Ms. Jacobs has more than 19 years experience in the medical device industry. She assists manufacturers and suppliers in developing and maintaining compliant quality system programs. She has served as a quality system expert witness on behalf of the US Food and Drug Administration. Ms. Jacobs is serving on the Board of Directors for the American Society for Quality (ASQ). She participated in FDA/Industry Grassroots Task Force meetings which implemented the program to pre-announce FDA inspections, annotate FDA Form 483s, and send close out letters after inspections. She also was a member of the Advisory Committee that wrote AdvaMed’s Points to Consider When Preparing for a QSIT Inspection. Ms. Jacobs is a member of the Regulatory Affairs Professional Society (RAPS), faculty member for AAMI’s GMP and Industry Practice Course and frequent speaker at educational programs for AdvaMed MTLI, MD&M, FOI Services and Management Forum Ltd.

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