The Parenteral Drug Association (PDA) announced it has signed an agreement to collaborate with Deloitte Consulting, LLP and the U.S. FDA’s Compounding Quality Center of Excellence to provide training to large pharmaceutical compounders in a variety of Good Manufacturing Practices (GMP)-related functions critical to improving the overall quality of compound drugs.
PDA is offering training in areas that are core to its educational offerings, including aseptic processing of sterile drug products, environmental monitoring, and manufacturing deviation investigations and Corrective and Preventative Actions (CAPA), as well as other topics to be determined.
“PDA is very happy to continue working with Deloitte and the U.S. FDA to provide this important GMP-related training,” said Richard Johnson, PDA President and CEO. “The agreement we signed includes provisions to extend this training over the next few years.”
PDA’s training is being offered under a larger relationship between the U.S. FDA’ Compounding Center of Excellence and Deloitte to assist large drug compounders, considered outsourcing facilities (under section 503B of the Federal Food, Drug and Cosmetic Act), improve the quality and safety of their pharmaceutical products. The courses will be offered online and in person, with a limited number of seats in the latter cases. Dates and times of the courses will be announced on the FDA website. PDA will offer the training developed for this partnership to other interested parties.
Providing training to the pharmaceutical/biopharmaceutical industry has been a core mission of PDA for 70 years. It conducts hands-on aseptic processing and laboratory training at the PDA Training and Research Institute in Bethesda, Md., and lecture-based training in Bethesda and other locations, and on-site training for companies.