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 1. Home
 2. Courses
 3. How to conduct Annual Product Reviews to achieve GMP Compliance


HOW TO CONDUCT ANNUAL PRODUCT REVIEWS TO ACHIEVE GMP COMPLIANCE

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Sorry, registration has ended.

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Faculty: Danielle DeLucy

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 * Date: 07-12-2020 01:00 PM - 07-12-2020 02:15 PM
 * Location: Online Event

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DESCRIPTION

Annual Product Quality Review (APR) is an evaluation conducted annually to
determine if there are any possible changes in the process or manufacturing of
the pharmaceutical product or any change in the specifications of the product or
any change in the manufacturing process. It is designed to minimize the product
defects and also the risks associated with the manufacturing of the
pharmaceutical product.

This webinar will give a brief overview of the general procedure for the
preparation and documentation of the Annual Product Quality Review and also
focuses on the regulations and the regulatory requirements as per US and Europe.
It will also discuss the comparative evaluation about similarities and
differences of requirements associated with the manufacturing of the drug
product in different countries. It is also necessary to know that the regulatory
requirements of different countries are different and hence this will further
guarantee the quality of the pharmaceutical product.

Areas Covered in the Session :

 * Annual Product Review Overview
 * How to write APRs
 * What needs to be included in the report
 * Outline the requirements for APR reporting
 * Review what information to include in the reports
 * A model of an example Annual Product Review Report
 * Discuss how well written APRs benefit your firm’s compliance

Who Should Attend:

 * Quality Assurance Teams
 * Compliance Teams
 * Regulatory Affairs Teams

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