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With this knowledge, you can predict when you must be ready. By examining the "hot topics" and your track record with the agency, you will be able to determine what are the most likely areas to be covered. This becomes the plan for gap analysis and checking on what you said you would do at the last inspection. The successful inspection is when you manage your agency’s expectations and then deliver on them. After the inspection, the responses are also very critical to prevent it from becoming a warning letter or even worse.
Why Should You Attend:
Performing poorly in an inspection can result in, at the minimum extra resources and time needed to address issues identified by the agency. More serious observations can result in warning letters and other harsher regulatory actions that can take product off the market, delay other submissions from being approved and damage your reputation in the marketplace. All of this translates to increased cost of operation. Failure to maintain products on the market or delays in approvals can negatively affect the value of the company and drive down stock price.
Areas Covered in the Session: This webinar will walk you through the elements you should plan for, the timing and the logistics of who should do the various components in preparation for the inspection. We will walk you through successful inspection strategies and logistics. After the inspection the putting together of a solid systemic CAPA is described and a process for tracking completion.
- When will the inspection occur
- What will be the hot topics likely to come up
- when do you begin preparation
- How do you prepare for this
- Strategies for preparing - determining your weak points
- Strategies for conducting the inspection
- Logistics of a successful inspection
- Putting a strong response in place
Who Will Benefit:
- QA and Compliance Staff
- Regulatory Affairs Staff
- Manufacturing Staff
- validation
- Senior Management
- process Development