Understanding the Scope of FDA's Inspection Authority and Its Ability to Access Company Records

This webinar will discuss the scope of the Food and Drug Administration’s (FDA’s) authority to inspect manufacturers of foods, dietary supplements, cosmetics, pharmaceuticals, and medical devices and the Agency’s ability to access company records. It will also cover the potential impact of the draft guidance document on drug inspections that FDA issued in July 2013.

Why Should You Attend:

Companies that manufacture products regulated by the USFDA are subject to inspection by the Agency, although the scope of FDA’s authority varies with the type of product being produced. Nevertheless, FDA investigators are trained to ask for information to which they are not legally entitled, in the hope that companies will provide such information “voluntarily.” Company personnel need to understand these limits (and how to respond when FDA tries to go beyond them) to protect their businesses.

This session is designed for manufacturers of foods, dietary supplements, cosmetics, pharmaceuticals, and medical devices. It will provide a clear overview of the extent of FDA’s inspection authority and what limits apply to different categories of products. It will also present many practical considerations to help companies prepare for an FDA inspection, deal with inspectors who may try to push the limits, and know when it may be appropriate to take firm stand against providing certain information.

Areas Covered in the Webinar:

• Scope of FDA’s inspection authority for different categories of products.
• What the issues discussed in FDA’s July 2013 draft guidance on “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug Inspection” mean for pharmaceutical companies.
• How to prepare for an inspection and steps to take to ensure that the event is handled correctly and efficiently.
• Keys to setting the tone for the inspection once the investigator has arrived.
• Successfully pushing back against FDA requests to take photographs or have access to excluded information.
• Considering when it may benefit the company to provide more information voluntarily.
• One thing not to do when asked by an FDA investigator.

Who Will Benefit:

This topic applies to personnel/companies in food, dietary supplements, cosmetics, pharmaceuticals, and medical devices industry. The employees who will benefit most include:

• In-house counsel
• Regulatory affairs managers
• Quality assurance/quality control personnel
• Production facility workers
• Corporate risk managers
• Audit
• Senior Management