FDA Inspections: Anticipation, Preparation, Reaction, Conclusion…Repeat

Why Should You Attend:

Anticipation Put yourself and 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!

Preparation Learn how to prioritize Quality System improvements and target potential problems. How do you instill a level of control that 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.

Reaction Learn how to put your plan in 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.

Conclusion 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.

Repeat Life with FDA is like a TV series. Are you a sit com, action adventure, suspense drama? Leverage what you learn to your advantage and bend the experience to your advantage on upcoming episodes (inspections). Be ready to make real changes to improve your operation, not just to placate FDA.

Understanding FDA’s approach to conducting inspections will make any encounters with FDA less pain and more gain. If you anticipate FDA’s interest in what you are doing you will be prepared when the worst things happen. What will bring FDA to your doorstep?

By understanding the risks that you face you can prioritize your quality system and focus on important things and not get bogged down in minutia. A risk continuum from NDA (highest risk), 510k, OTC, dietary supplement to cosmetics (lowest risk) is obvious, because the law states as much. However, withing each category of FDA regulated products there is a risk hierarchy that FDA follows to focus their resources. If you assume FDA does not care about cosmetics you should be aware that failures in “lower risk” products can cross over to “high risk” products that you thought were under control.

Preparation is the key to avoiding FDA problems. What level of control is necessary? That depends on the risks inherent to the products you manufacture and processes that you use to assure that all levels of risk are defined and appropriate controls are applied. If you put off analyzing the risk inherent to your products it is likely you will not be capable of supplying satisfactory answers to FDA when they are setting across the table from you. How you react to FDA will determine how long and how painful the experience will be. When FDA knocks, what do you do? Your reaction will set the stage for what is to follow.

If you do not anticipate what FDA is looking for and prepare your response then you will likely lead the investigator to the cheese. Having a plan and implementing it is highly recommended if you want to avoid a long-term negative relationship with FDA. How does the story end? The conclusion will depend on how you react to FDA. Were you able to answer all of their questions satisfactorily? Are there serious information gaps that will lead to 483 citations? If you know what is compliant and communicate the facts you will have a better experience.

Finally, if you learn from each encounter with FDA and make continuous progress toward improvement each successive inspection will have a more positive outcome and the time between inspections will lengthen.

Areas Covered in the Webinar:

• 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

Who Will Benefit:

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

From

• FDA regulated industries, including: drug, device, biologics, cosmetics, dietary supplements, tobacco, veterinary drugs, compounding pharmacies

John Misock
Senior Consultant, Ceutical Labs Inc

John Misock is a farm boy, born and raised in Ohio, who has travelled the regulatory globe. Recently John retired from the FDA where he served as a leading subject matter expert in personal care product regulatory issues. Prior to joining FDA, John was Director of Bio fermentation and global manufacturing compliance with The Estee Lauder Companies. After graduation from The Ohio State University and the University of Wyoming, John landed the coveted position of Director of Consumer Health Services for the State of Wyoming, where he led national efforts to adapt the principles of HACCP (hazard analysis critical control point) to all sectors of food and allied industries. John has spent his entire career as a leader and would like to share his hard-earned knowledge with you. If you meet John, be sure to ask him about sheep herding in the Big Horn Mountains of Wyoming!

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