Preparing for FDA inspections

Time and resources spent preparing for the inevitable inspection will pay back proportionately. By doing your homework and putting simple principles to work you can minimize the negative effects of the FDA’s power and put everyone in your organization at ease. By understanding the risks inherent in your products, you can develop a quality system that will align your operation with FDA’s expectations. Why live in fear when you can rest at night knowing you are ready?

• Prepare for an inspection
• Develop an action plan
• How to react when the day comes
• How to respond to a 483
• Take what you learn and improve your QMS

• Anticipating inspections
• Preparing for an FDA audit
• FDA Risk categorization
• Quality Systems and Control
• Importance of supplier agreements
• Avoiding contract laboratory traps
• Accommodating FDA during an inspection
• Documenting and presenting OOS results
• Sharing more information than necessary
• Correcting 483 deficiencies
• Learning from failures

Put yourself and your colleagues at ease by learning how to prepare for FDA,s inevitable visit. Learn how risks inherent in your product categories affect FDA behavior when they visit your firm.  Mitigate those risks by anticipating FDA’s concerns. Focus on what is important! Learn how to prioritize Quality System improvements and target potential problems. How do you instill a level of control that the FDA sees as appropriate?  Can you get what FDA wants in minutes? Do you understand what they are asking for? Learn how to plan for an FDA inspection and shorten the process considerably. Learn how to put your plan into action when FDA is present. You can influence FDA’s decision to take action just by how you respond to their questions. Silence is deadly, so knowing what to say and when is very important. Learn how to respond to a 483 citation. What should I do in those 15 days I have to respond? Can they take action if I do not respond? If you choke, you could be asking for more trouble.

Manufacturing, QA/QC, and regulatory affairs directors, managers, and supervisors

John Misock is serving in his fourth career as Senior Consultant with Ceutical Labs, Inc. Flower Mound, TX. He provides regulatory consulting services across all FDA-regulated industries. John retired from FDA in June 2019 where he was an SME in microbiological compliance and manufacturing. Prior to FDA John served in a global capacity with a multinational company responsible for regulatory compliance in all manufacturing facilities. Early in his career, John was Director of a state Food, Drug, and Cosmetics program and also served as Assistant Commissioner of Agriculture.