Events

UPCOMING EVENTS

Infection Prevention through Sterility Assurance & Microbiological Quality: Reflections from a Patient & Industry SME

Tuesday, April 9, 2024

DESCRIPTION OF MEETING: “Infection Prevention through Sterility Assurance & Microbiological Quality: Reflections from a Patient & Industry SME”

SPEAKER:
Dawn Nestola, Director Sterility Assurance & Microbiological Quality, GlazoSmithKline.

OVERVIEW OF PRESENTATION:
Sterility assurance and microbiological quality (SA & MQ) are fundamental to the production of pharmaceuticals/biopharmaceuticals, advanced therapy medicinal products (ATMPs), medical devices, and over-the-counter (OTC) medicines, contributing to product quality, safety, and promoting infection prevention in patients and consumers.

Recent updates to EU Annex 1 have mandated that manufacturers develop and actively maintain a robust contamination control strategy (CCS), and end-to-end SA & MQ are core to this regulatory requirement. Although a CCS primarily focuses on activities directly controlled by a manufacturer, elements that extend beyond the bounds of a GMP facility's four walls are just as important. In fact, SA & MQ begin elsewhere, with suppliers and sub-suppliers who provide, for example, device components and subcomponents, packaging components, manufacturing consumables (often sterile single-use systems), sterilization services, and raw materials, including aseptically collected patient cells (via apheresis), which may be the primary raw material in an ATMP. Likewise, SA & MQ do not terminate when a released product leaves the manufacturing facility, bound for a distribution center or customer. In contrast, SA & MQ end with each successful patient or consumer outcome when a product of appropriate microbiological quality (for its intended use) is consumed and/or properly used by the medical practitioner or recipient.

The speaker's presentation will focus on her patient experience with a life-threatening medical condition and offer reflections, through the lens of an industry SME, on her treatment journey and how SA & MQ contributed to her positive patient outcome.

SPEAKER BIO:
Dawn’s 24-year career as a microbiologist has been entirely focused on infection prevention through microbiological quality and sterility assurance. She is experienced in contamination control in the manufacture of sterile, low bioburden and non-sterile products, medical device development and associated clinical processing, and medical device sterilization.

Dawn presently works for GSK as Director of Sterility Assurance & Micriobiological Quality. Prior industry experience includes positions with Johnson & Johnson (McNeil and DePuy Synthes), Pfizer, and Pharmacia. She also enjoyed time as an adjunct professor teaching an accredited college level course on the fundamentals of aseptic processing. Dawn earned a Bachelor of Science degree in Microbiology from Michigan State University and holds a Master of Business Administration degree from Centenary University.

DATE:
Tuesday, April 9, 2024

TIME:
5:30-6:30: Networking Reception
6:30-8:00: Dinner in Main Ballroom
8:00-9:15: Presentation

LOCATION:
Desmond Hotel and Convention Center, Malvern, PA 19355

TICKET PRICE: $80.00

Register to this Event:
FOR BOOTH SPONSORS

“Contamination Control Panel Discussion and the PDA Delaware Valley Science Fair Finalists Displays”

Tuesday, June 18, 2024

DESCRIPTION OF MEETING: “Contamination Control Panel Discussion and the PDA Delaware Valley Science Fair Finalists Displays”

SPEAKER/PANEL:
Panel to be announced shortly.

OVERVIEW OF PANEL DISCUSSION:
Controlling contamination is a function that spans virtually throughout every sector of a GMP manufacturing and/or testing operation. The complexity of personnel gowning, incoming component entry, product contact component cleaning and sterilization, non-product surface cleaning and disinfection, cleaning and disinfection of structures and equipment, disinfectant efficacy performance, particulate removal and identification, environmental monitoring, tracing contamination, conducting investigations and meeting worldwide regulatory requirements will all be discussed in detail. This panel will delve into the complicated and critical areas that are required to assure product and patient safety as well as addressing domestic and foreign regulatory concerns.

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.

SPEAKER BIO’S:
To be announced shortly.

DATE:
Tuesday, June 18, 2024

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

Register to this Event:

“CURRENT FDA CBER REGULATORY INITIATIVES and PDA DEL VAL VENDOR NIGHT”

Wednesday, October 16, 2024

DESCRIPTION OF MEETING: Join the PDA DEL VAL membership for our meeting entitled, “Current FDA CBER 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 Center for Biologics (CBER) 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:
FDA CBER Speaker will be announced shortly

OVERVIEW:
Available shortly

SPEAKER BIO:
Available shortly

DATE:
Wednesday, October 16, 2024

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:
FOR BOOTH SPONSORS

PAST 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:
FOR BOOTH SPONSORS

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

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