PDA

Get 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.

Get 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.

Built on a reputation of excellence and founded in science, PDA training provides new and experienced professionals around the world with practical information and implementable solutions on essential industry topics related to the manufacturing science, regulation, and technology of drug products and substances. Our trainers are world-class experts with years of hands-on experience in their respective fields. Whether you are employed in industry, government, or academia, PDA has training that will benefit you!

The Co-chairs of the 2021 PDA/FDA Joint Regulatory Conference Program Planning Committee share their insights about this important conference, now in its 30th year. They will discuss the importance of hitting this significant milestone, what noted regulatory and industry speakers will be presenting, what’s new this year, what popular sessions are making a return, and what attendees can expect to gain from attending the event for compliance and regulatory updates.

This ebooklet walks through the steps required to take a biologic/biopharmaceutical product forward to commercial manufacturing. It distinguishes between a drug and biologic, which is key to understanding the complex requirements for biologics development and manufacture.

This chapter, excerpted from the book Good Distribution Practice, provides background on serialization and how, despite initial investment of time and money, it will allow greater tracking of medicinal product through the drug supply chain and reduce the chance that falsified medicines end up in the hands of the public.

The ebooklet addresses findings from the Consortium on Adventitious Agent Contamination in Biomanufacturing’s survey of virus contamination experience and mitigating controls and other research, reviews recommended risk management tools to avoid adventitious agent contamination, and provides a framework for a risk management process

This chapter, excerpted from the book Good Distribution Practice, draws on the author’s experience with shipping pharmaceuticals under controlled conditions, particularly over long distances, and his work toward solutions providers in the field.