Sponsored by the Product Quality Research Institute (PQRI)
Pharmaceutical quality practitioners may be interested in this upcoming October webinar on QbD sponsored by the Product Quality Research Institute, or PQRI. The most interesting sessions are the discussions of the QbD working group and the trends in regulatory science which will be at the start of the webinar.
The PQRI is a non-profit consortium of academic and industry groups, standard-setting bodies, and regulatory agencies whose purpose is to share information that “advances global drug product quality, manufacturing, and regulation”. The member organizations are
- Consumer Health Products Association,
- US FDA/CDER,
- Health Canada (the Canadian Drug Regulatory Agency),
- International Pharmaceutical Excipients Council of the Americas (IPEC-Americas),
- Parenteral Drug Association (PDA), and
- United States Pharmacopoeia (USP)
The PQRI holds regular meetings which are recorded and available on the organization’s web page. PQRI publications include articles, white papers on topics investigated by the group as well as regulatory submissions to recommend clarifications in guidance (like this one to the FDA on the Aseptic Processing Guidance). Membership in the PQRI is open to organizations only; members of those organizations may participate in institute activities, but the rest of us may only participate through the website and scheduled seminars.
Reach out to me if you want to know more or discuss your medical product development challenges.
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Text Copyright © 2019 Katrina Rogers