Seminar on Why is FDA at my Facility, and what do I do During an Inspection

Overview:

Many regulated companies preparing for FDA inspections are not prepared and the outcome can be negative as we see all the time with enforcement actions.  This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no matter if you are a Class I, II, III device or a pharmaceutical or biologics manufacturer.

This presentation will review and emphasize the do's and don'ts and cardinal rules as to interviewing, how to respond, reviewing documentation, etiquette, use of certain words, body language, responding to questions/requests, etc., and certainly replying to 483's and Warning Letters.

Emphasis is placed on the company's SOP on dealing with inspectors and knowing how to be prepared, proactive...and being able to defend and justify... and what it takes to achieve a favorable outcome.

This seminar provides background and understanding of the role played by the Agency, its administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections.

Who will benefit:

Industries

• FDA regulated Industries
• Medical Device
• Pharmaceuticals
• Clinical

Dietary Supplements

• Food
• Nutraceutical

Healthcare IT

• Technical Services
• Validation
• Engineering

Departments

• Top and Middle Management
• Quality Assurance/Management
• Compliance Management
• Manufacturing
• Laboratory
• Regulatory Affairs
• Information Technology
• Marketing & Sales
• Operations
• Research & Development

Types of facilities

• Manufacturing facilities
• Contract manufacturing facilities
• Distributors
• Packaging, Labeling
• API Suppliers
• Laboratories
• Importers
• Documentation Management

Please Click Here For The Agenda >>