GMP Quality Principles
Duration: 60 Minutes
We all know that when FDA appears at your door to conduct an inspection, 99% of the time, they want to ascertain if you are in compliance with the requirements stated in 21 CFR 210 & 211 - more commonly known as the Current Good Manufacturing Practice Regulations in Manufacturing, Processing, Packing, or Holding of Drugs.
On the internet, this portion of the CFR occupies 23 double column pages of fine print. While every practitioner in the pharmaceutical manufacturing and quality management business needs to have a copy of this information available when a specific question arises, for every day management and control of the GMP regulations a solid understanding of the GMP Quality Principles is more useful and can be the basis for assuring cGMP compliance.
Why Should you Attend:
Stories of problems encountered by pharmaceutical manufacturers who are found to fail FDA inspections and subsequent follow-ups are known to everyone in the industry. Manufacturing facilities have been closed pending changes needed to achieve full compliance and fines of $500,000,000 have been assessed. A solid knowledge of the principles of GMP Quality standards can be your day-to-day guideline for creating and maintaining full compliance with the GMP regulations.
Full compliance must be a top objective of everyone in this industry. The big question for most of us is how to achieve this necessary goal and still have time to complete our assigned responsibilities. To accomplish this, we have analyzed the GMP regulations and summarized them in a few basic GMP Quality Principles. Knowledge and use of these principles will not eliminate the need to have a copy of the regulations for reference, but it will answer most questions quickly and effectively.
Learning about the role and responsibilities of an efficient and effective GMP proponent and developing a solid understanding of the GMP regulations.
Objectives of the Presentation:
Who can Benefit:
- Responsibility of the Quality Control Unit
- Required qualities of buildings & facilities
- Control of components and drug product containers
- Process controls
- Packaging and Labeling
- Warehousing and Distribution
- Laboratory controls
- Records and Reports
- Returned and Salvaged product
This webinar will provide valuable assistance to all personnel in:
- Personnel interested in exploring the fields of pharmaceutical manufacturing
- New pharmaceutical manufacturing and quality supervisors and managers
- Administrative managers in charge of pharmaceutical manufacturing or quality
- Pharmaceutical manufacturing and quality Associates and Manager