This webinar will discuss the terms GLP and GMP, their definition, similarities and differences and their application in the biologics or pharmaceuticals development environment.
As the terms GLP and GMP are critical to those involved in therapeutics, using them correctly is important in maintaining credibility with regulatory health authorities. Additionally, ensuring that the regulations being used are the most up to date version is also critical, as the FDA will expect (and rightfully so), that the latest version is or is being implemented. No one wants to have a discussion with the regulators and be surprised by recent additions to the regulations.
The objective of this seminar is to define the terms, how they were developed, how they are applied and the differences and similarities between the two.
Why Should You Attend:
The terms GLP and GMP are often confused and used incorrectly. For example, the GMPs do not specifically mention a QA requirement; does that mean that the GLPs should be used as a guide for QA activities? Where can one go for this information? The requirements associated with GLPs and GMPs continue to evolve, as the FDA identifies new issues requiring clarification and control.As the terms GLP and GMP are critical to those involved in therapeutics, using them correctly is important in maintaining credibility with regulatory health authorities. Additionally, ensuring that the regulations being used are the most up to date version is also critical, as the FDA will expect (and rightfully so), that the latest version is or is being implemented. No one wants to have a discussion with the regulators and be surprised by recent additions to the regulations.
The objective of this seminar is to define the terms, how they were developed, how they are applied and the differences and similarities between the two.
Areas Covered in the Seminar:
- Nomenclature
- The birth, history and evolution of the terms GLP and GMP
- How the GLPs and GMPs came to be an their evolution.
- The major sections of the GLP and GMP regulations: similarities and differences
- A comparison of the two
- Avoiding confusion
- Who Will Benefit
- This seminar would be beneficial to anyone that plays any leadership role in an FDA manufacturing environment to produce, test, warehouse and/or ship biologics or pharmaceuticals, including:
- Leaders in manufacturing
- Quality control
- Quality assurance
- Warehouse functions
- Directors/Managers in regulatory affairs
- Document control
- Development and nonclinical functions
Course Provider
Janet Rose Rea,
