How to Survive FDA's New Inspection and Enforcement Practices

Why Should You Attend:

FDA inspections and enforcement recently have become much more aggressive. E.g., the number of 483s and warning letters has doubled over the last five years and shipment holds and multiple product recalls have been announced even for global players. One company had to pay 500 M$ fine as a result of failed inspections and inspectors ask for details they never did before. For the near future FDA expects multifold increase of inspections through the Generic Drug User Fee Amendments (GDFUFA) that will enable FDA to substantially increase the inspection frequency to every 2 years from currently 6-7 years. In addition, the FDA has just released a new powerful guidance listing a variety of circumstances that can even delay, deny, limit or refuse an FDA inspection overall.

This webinar will help survive the new practices through getting up-to-date expert information on the new inspection practices and for preparing your organization accordingly.

Areas Covered in the Webinar:

• Inspection process for API, drug and device manufacturers
• Recent changes: summary and details
• Going through "Reasons for Delaying or Refusing a Drug Inspection" from the new FDA guide
• 10 examples of recent observations/deviations that came as a surprise
• Strategy to respond to the new type of inspections
• Case study: Going through a typical inspection process
• Preparing your staff for the new FDA inspections
• Conducting FDA inspection-like internal audits
• Tips on how to respond during inspections to avoid inspectional observations
• The role of the exit meeting to avoid enforcement
• Developing a corrective action plan with identification of the root cause
• Developing a detailed preventive action plan to avoid reoccurrence
• How to use all this information for all national and international inspection

Hand-Outs:

For easy implementation, attendees will receive:

• 80-Page FDA Inspection Survival Guide
• Two SOPs:
• FDA Inspections - Preparation, Conduct, Follow Up
• Responding to FDA 483 Inspectional Observations to Avoid Warning Letters

Who Will Benefit:

• QA managers and personnel
• QC directors and substitutes
• Operations supervisors and staff
• Regulatory affairs
• Internal auditors
• Training department
• Documentation department
• Consultants

Instructor Profile:

Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. He is the author of the books "Validation and Qualification in Analytical Laboratories" and "Validation of Computerized Analytical and Networked Systems." He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and validation around the world. This includes seminars, workshops and presentations for the US FDA, China CFDA, ISPE, PIC/S and several other national health care agencies.

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