Beyond Compliance: CMC and QA Synergy for a Culture of Quality

Join PDA WCC for a full-day seminar navigating inspection readiness for pharmaceutical manufacturers and sponsors.

About this Event

Join the 2025 PDA WCC Interactive Seminar on October 8th to engage with seasoned QA leaders and regulatory experts from top-tier pharma and global regulatory bodies. This interactive, hands-on experience includes:

• Real-world PAI case studies and lessons from the field
• Cross-functional small-group discussions for QA, manufacturing, and operations leaders
• FDA and global inspection trends for commercial facilities
• Exclusive training materials to help benchmark and enhance your internal readiness programs
• Live Kahoot quizzes and roundtable simulations to drive retention and dialogue

This seminar is ideal for teams who lead from the front—onsite and under pressure.

Speakers:

• Jennifer Cheung | VP External Quality Operations, Gilead Sciences
• Jim Stumpff | President James Stumpff & Associates, LLC

Visitor Policy:

All attendees must be pre-registered on Eventbrite prior to attending. Walk-in registration will not be available. Attendees will need to bring a government-issued photo ID to check in at the PDA West Coast Chapter registration table.

Interactive Seminar Speaker Bios:
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Jennifer Cheung | VP External Quality Operations, Gilead Sciences

Jennifer Cheung has over 30 years of quality, compliance, and regulatory experience in biotechnology, pharmaceutical, and cell and gene therapy manufacturing. Currently the Vice President of External Quality Operations at Gilead Sciences, Jennifer leads a team of quality professionals to provide oversight for contract manufacturing and testing network globally and ensure supply of quality medicines to patients by championing GMP compliance sustainability and delivering on regulatory strategies for successful pipeline launch and market assess for all products. Prior to joining Gilead, Jennifer was the Chief Quality Officer at WuXi Advanced Therapies, a contract testing, development, and manufacturing organization (CTDMO), where she led a global organization of professionals in quality assurance, quality control, regulatory affairs, analytical development, and contract testing services. Jennifer also held various leadership positions at Roche/Genentech in different countries including US, China, Singapore, and Switzerland on quality, compliance, and external policy roles. Jennifer is a member of the Biopharmaceutical Advisory Board at Parenteral Drug Association (PDA) and co-leading the revision of Technical Report 82 Low Endotoxin Recovery (LER). Jennifer has a BS degree in Microbiology and MS degree in Manufacturing Management.

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James Stumpff | President James Stumpff & Associates, LLC

President of James Stumpff & Associates, providing quality and

James “Jim” Stumpff is President of James Stumpff & Associates, providing quality and

regulatory compliance consulting to the medical device and biopharmaceutical

industries.

• Over 30 years combined FDA and Industry biopharmaceutical and medical device regulatory and compliance experience
• Previous position as Executive Director of Quality at Adamis\DMK, Pharmaceuticals including responsibility for Regulatory Affairs, Pharmacovigilance, and Quality Assurance

• Previous position as Principal Consultant at Parexel International for approximately 10 years providing strategies and solutions for biopharmaceutical and medical device clients from small start-ups to large global organizations

• Publishes industry articles and a presenter at many conferences as a recognized thought leader in the industry

While at FDA, Jim was personally involved in many historically important events that

shaped future FDA programs and policies including:

• Inspections and investigations of those involved in the Generic Drug Scandals in the late 1980s leading to civil penalties and criminal prosecutions for fraud and resulting in the FDA implementation of the pre-approval program and disbarment policy

• Inspections leading to consent decree of injunction of blood banks, medical device and pharmaceutical companies including the first ever corporate wide injunction of a medical device manufacturer

• Investigation of the largest Medicaid and insurance fraud scheme in cooperation with the Federal Bureau of Investigations (FBI) known as “Operation Goldpill” leading to many criminal prosecutions

• Inspection and investigation of a Clinical Investigator leading to criminal prosecution for fraud as clinical trial subjects were non-existent

Jim’s insights and knowledge have contributed significantly to shaping the discourse

around regulatory practices in the biopharmaceutical and medical device industries.

Platinum Sponsors:
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FAQs

How can I contact the organizer with any questions?

You can contact the event organizer by sending an email to cnN2cCB8IHdjY3BkYSAhIG9yZw==. Please allow a few days for the response, emails will not be monitored on the day of the event.

Is my registration fee or ticket transferable?

Tickets are not reimbursable, however you can transfer it by 28SEP25 to whoever would like to attend on your behalf.

Cancellation & Refund Policy:

Tickets are non-refundable. Seminar seating is confirmed and reserved in advance. All sales are final and no refunds will be provided, including but not limited to non-attendance at the event. If a registrant cannot attend, substitutions are welcome no later that 10 days before the event (Tickets are not reimbursable, however you can transfer it by 28SEP25 to whoever would like to attend on your behalf.). The Chapter reserves the right to cancel a seminar if the minimum number of attendees is not met by Monday prior to the event. The Chapter reserves the right to not answer emails or phone calls on the day of the event.

Privacy Policy:

We manage your personal data responsibly and align with PDA Privacy Policy.

REGISTRATION AGREEMENT: By registering to this event, I consent to the WCC PDA recording and/or photographing me and using those recording(s) and/or photograph(s) in the future WCC PDA promotional and marketing material, and to send me promotional information via email.

Agenda


🕑: 08:00 AM
Registration Opens

🕑: 08:00 AM - 09:00 AM
Complimentary Breakfast

🕑: 09:00 AM - 09:15 AM
Welcome

🕑: 09:15 AM - 09:30 AM
Module 1. Introduction to Inspection Readiness

🕑: 09:30 AM - 10:15 AM
Module 2. Lecture 1

🕑: 10:15 AM - 10:30 AM
Morning Break

🕑: 10:35 AM - 11:20 AM
Module 3. Lecture 2

🕑: 11:20 AM - 11:40 AM
Morning Break

🕑: 11:40 AM - 12:10 PM
Module 4. Interactive Exercises/Quiz

🕑: 12:10 PM - 01:10 PM
Lunch Break

🕑: 01:10 PM - 02:10 PM
Module 5. Interactive Exercises (round tables)

🕑: 02:10 PM - 02:30 PM
Afternoon Break (optional)

🕑: 02:30 PM - 03:15 PM
Module 6. Interactive Exercises 2 (round tables)

🕑: 03:15 PM - 03:30 PM
Concluding Remarks

🕑: 03:30 PM - 04:30 PM
Refreshments and Networking

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