Proper Execution of Annual Product Reviews

By: Danielle DeLucy

Recorded Session

Duration
60 Minutes

Training Level
Intermediate to Advanced

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Transcript

($179) - Transcript (PDF Transcript of the Training)

Recorded Session

($239) - Downloadable Session

USB

($350) - USB

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Webinar Details

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.

WHY SHOULD YOU ATTEND?

This webinar will 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.

AREA COVERED

This webinar will review:

Annual Product Review definition
What needs to be included in the report
A model of an example Annual Product Review Report
Review of citations

LEARNING OBJECTIVES

Discuss how to write APRs
Outline the requirements for APR reporting
Review what information to include in the reports
Discuss how well written APRs benefit your firm’s compliance

WHO WILL BENEFIT?

Quality Assurance/Quality Control Directors, Managers, and Specialists

Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists

Engineering/Development Directors, Managers, and Specialists

This webinar will review:

Annual Product Review definition
What needs to be included in the report
A model of an example Annual Product Review Report
Review of citations

Discuss how to write APRs
Outline the requirements for APR reporting
Review what information to include in the reports
Discuss how well written APRs benefit your firm’s compliance

Quality Assurance/Quality Control Directors, Managers, and Specialists

Regulatory Affairs/Regulatory Compliance Directors, Managers, and Specialists

Engineering/Development Directors, Managers, and Specialists

SPEAKER PROFILE

Danielle DeLucy, MS, is owner of ASA Training and Consulting, LLC which provides Pharmaceutical and Biologics based companies with training and quality systems assistance in order to meet Regulatory compliance. Prior to this role, Danielle has been in the industry for 15 years serving in numerous Quality Management Roles, such as the Director of Product Quality, the oversight of Sterility Assurance practices and provided QA oversight of numerous filling and packaging operations. Danielle began her QA career as a Quality Control Pharmaceutical Microbiologist at a contract laboratory where she performed various tests for their clients. In the years after, she has held positions in the Quality management arena while increasing her responsibility. She has helped to lead many Regulatory Health Inspections and was instrumental in the coaching process of her peers prior to any inspection. Currently, Danielle assists companies who are faced with warning letters, consent decrees and those wishing to improve compliance establish more robust quality systems so that the company can succeed.

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