October Event: Audits and Inspections
Audits and Inspections: Setting Yourself Up for Success
Wednesday, October 23, 2019
Event Agenda:
Date: Wednesday, 23 October 2019
Time*:
5:15 – 6:00 PM Registration, Snacks, & Speed Networking
6:00 – 6:05 PM Welcome and Announcements
6:05 – 7:05 PM Program Presentation
7:05 – 7:30 PM Q & A *Times are approximate.
Speaker:
Bill Bressler
Director of GXP Compliance and Quality Systems
Navigate BioPharma Services
Program Topic:
Regulatory authorities, including the Federal Food and Drug Administration (FDA) and European Medicines Agency (EMA) regularly inspect a company’s manufacturing and distributing of regulated products to verify compliance with relevant regulations. These inspections ensure the reliability and integrity of the data that support the quality, safety, and effectiveness of drugs and medical devices once they are marketed. Several types of inspections can be performed, including pre-approval inspections once a company submits an application to market a new product, a routine inspection of a regulated facility, or a “for-cause” inspection to investigate a specific problem that has come to FDA’s attention. This presentation will identify best practices for manufacturers during regulatory inspections and will focus on the three primary areas of inspection/audit management:
1) Preparation of staff and documents for the inspection
2) Preparing your site for the tour
3) Setting up the inspection room to your advantage
Speaker Biography:
William (Bill) Bressler is a regulated industry professional with 32 years of Engineering and Quality experience. He is a contributing author for 9 regulatory applications for drug or device approval, providing direct support for 8 pre-approval inspections and the approval of 5 drug/device products. Bill has experience in both pharma and medical device areas. He has supported drug product programs that range from aseptic injectables to non-sterile liquids for oral administration. His experience with device products range from combination products and companion diagnostics to simple mechanical fixtures. Bill has been responsible for the architecture, improvement and maintenance of Quality Systems, System Lifecycles, and Product Lifecycles in compliance with 21 CFR Parts 11, 49, 58, 211, 803, and 820, and select ICH regulations. He is currently the Director of GMP Compliance and Quality Engineering at Navigate BioPharma Services.
Location:
Pfizer Inc.10770 Science Center Drive (visitors center)
Conference Room #1110
San Diego, CA 92121
** Please make your reservation early. The pre-registration due date is Monday, 14 October 2019. Advanced registration is appreciated to assist in event planning.
** Space is limited for our monthly programs. Registration is capped at 84 participants. Register today to ensure your seat. Once our limit is reached, registration will close. Events with closed registration will not allow walk-ins.
Online registration (through Monday 14 October 2019): $15 SDRAN Member
$25 Non-Member
Onsite Registration: $25 SDRAN Member
$35 Non-Member
For Questions Email: programs@sdran.org
DIRECTIONS:
From the North
I-5 South toward San Diego
Take Exit 29, turn left into Genesee Ave
Turn right onto Science Center Dr
CB2 Visitors Center is located at the end of the cul-de-sac
From the South:
I-5 North toward Downtown
Take Exit 29, turn right into Genesee Ave
Turn right onto Science Center Dr
CB2 Visitors Center is located at the end of the cul-de-sac