Quality risk management plans provide identified actions to ensure a continuous supply of safe and effective drug products
The purpose of a quality risk management plan is to help ensure continued compliance with regulatory requirements, such as good manufacturing practices or good laboratory practices, when events occur during manufacturing that potentially impact patient safety and product quality.
Learn the four basic elements that should be included in a quality risk management plan.
Read this article in Pharmaceutical Technology’s December 2019 Regulatory Sourcebook.
Pharmaceutical Technology
eBook: Regulatory Sourcebook, December 2019
December 2019
Pages: 12–13
When referring to this article, please cite it as S. Schneipp, “Quality Risk Management Plans Create Effective Quality Systems," Pharmaceutical Technology Regulatory Sourcebook eBook (December 2019).
Why is the PDA Pharmaceutical Microbiology Conference the Hottest Ticket in the Industry?
October 10th 2024Get a glimpse of the power and popularity behind the PDA Pharmaceutical Microbiology Conference from two planning committee members, Julia Marre, PhD (Associate Director, Scientific and Regulatory Affairs at Pocket Naloxone Corp) and Dawn Watson (Executive Director, Global Micro Quality and Sterility Assurance at Merck). This candid conversation reveals why this industry event is so influential…and always sold out! The speakers discuss what makes the PDA Pharmaceutical Microbiology Conference so vital to industry professionals, as well as how to become a part of this dynamic professional community.