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Attend this webinar to understand the purpose of the Annual Product Review, similarities and differences between US, EU and Canadian requirements, more. (see full course description)

 
 
 

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Training Course Syllabus:


Annual Product Quality Reviews: 2015 FDA, EU & Canada Regulatory Requirements Webinar

Time: 11:30 AM PDT, 02:30 PM EDT

Duration: 90 Minutes

Instructor: John G. Lanese


Description:

In this webinar we will discuss the Annual Product Review (APR), or Annual Product Quality Review. The discussion will include the regulatory requirements found in the US, EU and Canadian GMPs. It will itemize what should be covered in the APR and the use of risk analysis to identify the critical data. The emphasis will be on the defined purpose of the Annual Product Review - to identify areas for product and process improvement. The discussion will also point out that the recent US and EU guidances on process validation will bring new purpose and visibility to the Annual Product Review.

Why Should you Attend:

The Annual Product Review has been a requirement since the implementation of the US GMPs in 1979. It is one of the best tools for proactively identifying areas for the improvement of the product and process. However, most companies have done a relatively superficial job in the preparation and follow-up of the APR. The publication of new process validation guidance by the FDA in 2011 and a revised chapter on process validation in the EU in 2015 will place more focus on the Annual Product Review. Pharmaceutical firms should be looking for ways to make the Annual Product an effective component of the Quality System.


Objectives of the Presentation:


  • The purpose of the Annual Product Review

  • Similarities and differences between US, EU and Canadian requirements

  • What should be considered for inclusion in the Annual Product Review

  • The use of risk analysis in determining the actual content of an Annual Product Review

  • Management involvement in the review of the Annual Product Review

  • How the Stage 3 of process validation can be satisfied through the Annual Product Review

Seminar Summary:

Attend this webinar to understand the purpose of the Annual Product Review, similarities and differences between US, EU and Canadian requirements, more. (see full course description)

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