UPCOMING EVENTS
VENDOR NIGHT and “Current Regulatory Initiatives”
October 17, 2023
DESCRIPTION OF MEETING: Join the PDA DEL VAL membership for our meeting entitled, “Current FDA Initiatives” coupled with our Annual Vendor Night Extravaganza at the Desmond Hotel and Convention Center in Malvern, PA.
The evening will start with our Annual Vendor Night Extravaganza which will feature 40 vendors displays in the Foyer and Main Room of the Desmond Hotel. Included will be food stations, beverages, a cash bar and 40 vendor raffles. Per the schedule below, the presentation on “Current FDA Initiatives” will be conducted in the Amphitheater of the Desmond Hotel (3rd Floor of Conference Center). This presentation will focus on what current and upcoming FDA initiatives exist in the industry relating to sterile manufacturing and testing operations. This is a must-see presentation and please register early as space will be limited. More Information to be posted soon.
Speaker:
Tamara Ely
FDA Branch Chief, Division of Drug Quality II, Office of Manufacturing Quality, Office of Compliance, CDER
Date:
Tuesday, October 17, 2023
Time:
4:00-7:15: Networking, food stations, beverages, a cash bar and vendor raffles in Exhibit Hall
7:30-9:00: Presentation
Location:
Desmond Hotel and Convention Center, Malvern, PA 19355
Ticket Price: $80.00
Register to this Event:PAST EVENTS
Complying with EU GMP Annex 1:
How are GMP Organizations Complying with Released Guidance?
DESCRIPTION OF MEETING: Join the PDA DEL VAL membership for a Dinner Meeting at the Desmond Hotel and Convention Center in Malvern, PA for a panel discussion surrounding the review and implementation of the new EU GMP Annex 1, Manufacture of Sterile Medicinal Products into operations. This meeting will include panel participants from GMP organizations who are currently implementing strategies to meet the requirements in the newly released guidance documents. This moderated session will include the ability of the audience to ask the panelists pertinent questions as to how they and their organization are addressing each phase of the released guidance. The basis of the meeting is for GMP organizations to learn from other GMP organizations on how they may be implementing the needed and required attributes to comply with the guidance.
Panelists/Moderator:
Pat Bailey - Merck & Company
Angel Salaman - Janssen Pharmaceuticals
Mitch Garber - 2seventybio
Art Vellutato, Jr. – Veltek Associates, Inc. – Moderator
Date:
Wednesday, April 19, 2023
Time:
5:00-6:00: Networking and Cash Bar
6:00-7:30: Dinner Buffet
7:30-9:00: Presentation
Location:
Desmond Hotel and Convention Center, Malvern, PA 19355
Ticket Price: $80.00
JIT FOR CAR-T AND PTC FOR GENE THERAPY APPLICATIONS AND
THE PDA DELAWARE VALLEY SCIENCE FAIR
Finalists Displays:
DESCRIPTION OF MEETING: Currently CAR T products typically represent the final treatment option for patients suffering from various forms of cancer. It is critical that CAR T products are manufactured and returned to the patient in an expedited manner. To achieve this goal, manufacturers of CAR T products must adopt and utilize Quality Risk Management (QRM) principles during manufacture, testing, and release. Risk based contamination control strategies must be employed from apheresis collection through final product release. A risk assessment, encompassing each step of the manufacturing process, should be performed to highlight potential areas of microbial ingress. Where possible, mitigating actions must be implemented to eliminate risk or reduce risk to an acceptable risk level. Based on a well-defined and documented microbial contamination control strategy, it should be possible for manufacturers to implement a just-in-time microbiological release strategy. This meeting will highlight microbial contamination control and testing risks that can be identified throughout each stage of the manufacturing process that will allow for a potential just in time release of CAR T products.
SPECIAL EVENT: The PDA Delaware Valley Science Fair has been supported by the Delaware Valley Chapter of PDA for over 30 years. As judged by the PDA Planning Committee, the finalists and their families will all be in attendance with their displays in the foyer and relate to the entire assembly a summary of their science project and results. These amazing kids are the next generation of scientists in our world. Come support their efforts.
Speakers:
Katrina Hosbach - Adaptimmune
Date:
Thursday, June 15, 2023
Time:
5:00-6:00: Networking and Cash Bar – PDA Delaware Valley Student Science Fair Displays
6:00-7:30: Dinner Buffet
7:30-9:00: Presentation
Location:
Desmond Hotel and Convention Center, Malvern, PA 19355
Ticket Price: $80.00
To stay up to date on where we have been, visit our Past Events page
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EVENTS
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