All the GMP manufacturing facility at its lifetime will experience various warning letters or 483 observations, a regulatory inspection at some point. Many times, the outcome of the inspection results is a 483 or a Warning Letter.
To get out of it and avoid additional problem, it depends on how your system is set up as core element and what rectifications you are doing to fix people process program, system etc, but more importantly to a large extent how you are interacting with FDA through response in a timely and succinct manner. Hence it is imperative to learn in detail, how to respond a 483 and warning letter.
In this training You will learn what are the regulatory expectations for firms that have received a 483 or Warning Letters; as well as, the consequences of not providing a proper response, components of a response and how to correctly structure and the submit process so that the regulatory agency’s expectations are met and the submission process is properly executed.
The Training Package enables you to deliver your own training with ready-to-use, customizable slides, trainer notes & certificate to issue. Why pay annually for online training that can’t be tailored to your needs?
Download instantly after payment.
Approximate Duration 45-60 minutes.
Cost : 
: Limited Period Offer
Package contains :
- E-learning Video file in mp4 format
- Course Presentation Slides PPT
- An instructor PDF containing slides and class room Instructions to talk ( Transcription of Audio )
- Student PDF document with notes to write during the class
- Attendee Certificate format to issue upon completion
Areas covered
- Regulatory policies and procedures in regard to FDA 483 observations or Warning Letters.
- Timeline and process of submitting response
- Consequences of not submitting in time and actions which can be taken
- The audience to focus while writing the response
- Components and structure of response. The cover letter, body & attachments
- 483 and warning letter real examples and contents
- Response checklist to follow
- Process of submission of response
- Post response activities & outcomes
- Common mistakes to avoid in the whole process
Price :
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