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2020 PDA Pharmacopeia Conference

September 29 - October 1

Pharmacopeias have a well-established history to help protect and improve the health of people around the world through public standards and related programs that help ensure the quality, safety, and benefit of medicines. This mission is shared by many stakeholders to the pharmacopeias, including regulatory agencies and the bio/pharmaceutical industry. There are several examples of […]

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8:00 am

Webinar: Microbial Quality Control in Manufacturing of Medicinal Products

September 29 @ 8:00 am - 9:00 am PDT

There is a steady increase in FDA 483s related to microbiology. Though most are for sterile products, non-sterile and terminally sterilized products are also scrutinized by the regulators. These issues span from manufacturing, where systems are inadequate to control microbial contamination to laboratory operations where media, test method validations and testing is non-optimal. These 483 […]

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