PDA Regulatory Affairs & GMP Links to Pharmacovigilance Interest Group Virtual Meeting

Hello IG Members and Industry Professionals!

We are excited to announce a PDA Regulatory Affairs and GMP Links to Pharmacovigilance Interest Group will hold a joint virtual meeting on Thurday 15 May, 2025 at 12:00PM - 1:00PM EST to discuss: The establishment and deviations from Critical Quality Attributes (CQAs) and their link to the Quality Target Product Profile (QTPP).

The QTPP serves as the foundation for defining CQAs, which are then used to guide product and process development, ultimately ensuring the consistent delivery of a high-quality drug product. Understanding and controlling CQAs is crucial for achieving the goals outlined in the QTPP!

Therefore, deviations from these critical attributes requires prompt attention to maintain product quality and patient safety.

Our discussion will focus on the relationship between QTPP and CQAs and the potential impact of CQA deviations on both the product and patients.

This meeting will be facilitated by Regulatory Affairs Interest Group leader Ruhi Ahmed and GMP Links to Pharmacovigilance Interest Group leader Doug Roepke.

Registration is required for this event. Please register through the link below:

This Interest Group Virtual Meeting will be open to all industry professionals interested in this topic. IG VMs are not recorded and are unique forums for in-depth discussion on specific topics. These discussions are normally reserved as a PDA member benefit.

Please submit questions or topics in advance to your facilitators via [email protected] or by posting on PDA Regulatory Affairs LinkedIn page .

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We look forward to engaging with you on this topic!