How to Conduct Annual Product Reviews to Achieve GMP Compliance
75 Minutes
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 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.
AREA COVERED
- Annual Product Review definition
- What details 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 needs to be included in the reports
- Discuss how well written APRs benefit your firm’s compliance
WHO WILL BENEFIT?
- Quality Assurance Teams
- Compliance Teams
- Regulatory Affairs Teams
- Quality Assurance/
- Quality Control Directors,
- Managers, and Specialists
- Regulatory Compliance Directors
- Engineering/Development Directors
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.
- Annual Product Review definition
- What details 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 needs to be included in the reports
- Discuss how well written APRs benefit your firm’s compliance
- Quality Assurance Teams
- Compliance Teams
- Regulatory Affairs Teams
- Quality Assurance/
- Quality Control Directors,
- Managers, and Specialists
- Regulatory Compliance Directors
- Engineering/Development Directors
Speaker Profile
Danielle DeLucy
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 …
Upcoming Webinars
EEO-1 Reporting Deadline is December 5, 2023 – Now is the t…
By:Margie Faulk
Nov. 30, 2023
10:00 AM PDT | 01:00 PM EDT
Conflict Resolution in a Remote Workplace
By:Natasha Nurse
Nov. 30, 2023
10:00 AM PDT | 01:00 PM EDT
Strategic Interviewing & Selection: Getting the Right Talen…
By:Pete Tosh
Nov. 30, 2023
12:00 PM PDT | 03:00 PM EDT
Bootcamp for New Managers and Supervisors: Avoid These 7 Mi…
By:Marcia Zidle
Nov. 30, 2023
10:00 AM PDT | 01:00 PM EDT
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
By:Dr. Susan Strauss
Dec. 1, 2023
12:00 PM PDT | 03:00 PM EDT
Workplace Investigations 101: How to Conduct your Investiga…
By:Dr. Susan Strauss
Dec. 4, 2023
10:00 AM PDT | 01:00 PM EDT
Cleanroom, Microbiology and Sterility Assurance Practices f…
By:Kelly Thomas
Dec. 4, 2023
12:00 PM PDT | 03:00 PM EDT
Wage And Hour Laws: Ensuring Compliance With The Fair Labor…
By:Diane L. Dee
Dec. 5, 2023
10:00 AM PDT | 01:00 PM EDT
Successfully Negotiating the Labor Agreement
By:Gerry McLaughlin
Dec. 5, 2023
12:00 PM PDT | 03:00 PM EDT
5 Key Components of Good Manufacturing Practices to obtain …
By:Meredith Crabtree
Dec. 5, 2023
12:00 PM PDT | 03:00 PM EDT
How to Manage Conflict in the Workplace
By:Susan Schoenfeld
Dec. 5, 2023
10:00 AM PDT | 01:00 PM EDT
Understanding the incredible uses and fallbacks of ChatGPT
By:Justin Muscolino
Dec. 5, 2023
10:00 AM PDT | 01:00 PM EDT
Neutralizing Harassment - How to Promote the Proactive Pers…
By:Beverly Beuermann-King
Dec. 5, 2023
12:00 PM PDT | 03:00 PM EDT
Changing Behavior: Why Rewards and Punishments Often Aren't…
By:Rebecca Staton-Reinstein
Dec. 6, 2023
12:00 PM PDT | 03:00 PM EDT
Using Better Managerial Decision Making - to get great resu…
By:Bill Straubinger
Dec. 6, 2023
12:00 PM PDT | 03:00 PM EDT
Hybrid Workplace: 10 Best Practices to Manage Your Team’s P…
By:Marcia Zidle
Dec. 6, 2023
12:00 PM PDT | 03:00 PM EDT
Human Error Reduction Techniques for Floor Supervisors
By:Ginette M. Collazo
Dec. 6, 2023
10:00 AM PDT | 01:00 PM EDT
Excel - Pivot Tables - The Key To Modern Data Analysis and …
By:Mike Thomas
Dec. 7, 2023
10:00 AM PDT | 01:00 PM EDT
Form W-9 Compliance to Avoid Penalties: TIN Verification, B…
By:Patrick Haggerty
Dec. 7, 2023
12:00 PM PDT | 03:00 PM EDT
Using Stay Interviews To Improve Employee Retention & Engag…
By:Pete Tosh
Dec. 7, 2023
12:00 PM PDT | 03:00 PM EDT
Using High-Performance Coaching for Managers to Address Per…
By:William J. Rothwell
Dec. 7, 2023
12:00 PM PDT | 03:00 PM EDT
FDA Audit Best Practices - Do's and Don'ts
By: Charles H. Paul
Dec. 12, 2023
10:00 AM PDT | 01:00 PM EDT
FDA Technology Modernization Action Plan (TMAP) and Impact …
By: Carolyn Troiano
Dec. 12, 2023
10:00 AM PDT | 01:00 PM EDT
Become an excellent Critical Thinker to greatly improve you…
By:Bill Straubinger
Dec. 13, 2023
10:00 AM PDT | 01:00 PM EDT
Stay Interviews: A Powerful and Low-Cost Employee Engagemen…
By:Marcia Zidle
Dec. 13, 2023
10:00 AM PDT | 01:00 PM EDT
Learn the Do's and Don'ts of Opening Business Bank Accounts
By:Justin Muscolino
Dec. 14, 2023
12:00 PM PDT | 03:00 PM EDT
Project Management for HR, Administrative Professionals, an…
By:Rebecca Staton-Reinstein
Dec. 15, 2023
12:00 PM PDT | 03:00 PM EDT
Writing Effective 483 and Warning Letter Responses
By:Kelly Thomas
Dec. 19, 2023
12:00 PM PDT | 03:00 PM EDT