Cell and Gene Therapy - From Promise to Cure
Announcements
Don’t miss this unique opportunity to hear from and engage face-to-face with numerous regulatory and industry leaders.
Assist in developing, writing, and fine-tuning PDA’s fourth standard focused on virus retentive filters and viral safety. Express your interest today!
Help PDA review and assess the draft revision of GUI-0104, Good Manufacturing Practices for APIs. Volunteer by emailing Ruth Miller at rmiller@pda.org.
Events and Training News
Expand your understanding of pharmaceutical packaging with training courses focused on blow-fill-seal technology, and container closure systems and integrity testing.
Oct. 21-23, hear presentations from global regulatory and industry experts who will share recent case studies and current trends in the field of pharmaceutical microbiology.
People are at the heart of a successful, reliable, safe, and high-quality work environment. Choose from 5 training courses that will help you ensure that this key factor is prioritized.
Topic Areas
EMA’s consultation on its strategy for advancing engagement with regulatory science over the next five to ten years is open for input through 30 June 2019.
EMA has issued a new Q&A document detailing the steps that EMA and EU member states are taking to prevent drug shortages, no matter how the Brexit discussions evolve.
Share your experience with current technology transfer practices. Open until Feb. 22.
Technical Publications
Read Technical Report No. 81: Cell-Based Therapy Control Strategy on the PDA Technical Report Portal
Sign up for Email Table of Contents and never miss a PDA Journal!
Contamination Prevention for Nonsterile Pharmaceutical Manufacturing offers best practices and explains where the most common microbiological risks reside.
Global Community
The PDA Membership Advisory Committee is now accepting volunteers for the 2019-2020 Term. Apply today.
New for April: Updates from the Ph. Eur. Commission, Bracing for Medical Device Shortages, and more…
Check out this month’s Volunteer Spotlight featuring Dawn Downey, PhD - one of our many amazing volunteers doing great things within the PDA community!
PDA offers a broad range of conferences and workshops on trending topics and hands-on training courses that provide practical information and implementable solutions. Find out about all of PDA’s upcoming events in the U.S., Europe, and Asia!
In this one-on-one interview, Brian J. Hawkins, PhD, Chief Technology Officer, Pluristyx, Inc. discusses his poster on assessing cell viability after cryopreservation.
Establishing a comprehensive microbial control strategy for your company is a key component of contamination control and an expectation of regulatory agencies as highlighted in the revised version of Annex 1. This two-day training course will be a complete review of all aspects of a contamination control program.