$25 – $200

Event Information

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Date and Time

Location

Location

WellsFargo Event Center (To be confirmed)

333 Market St

Annex Building

San Francisco, CA 94105

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Event description

Description

Explore the circumstances that impact the quality, safety, and availability of drugs and gain new perspectives and discuss best practices on the evolving regulatory landscape, supply chain risks, quality culture, and challenges in manufacturing:

  • Latest FDA inspection findings;

  • Compliance/enforcement trends;

  • Quality trending;

  • Effective quality systems;

  • Consent decree lessons learned).

A wonderful opportunity to share some of our experiences as professionals working in biopharma and regulatory affairs.


Speaker:

Lance De Souza, FDA Compliance Officer, Office of Pharmaceutical Quality Operations – Division IV

With more than 17 years of experience in the U.S. FDA’s Office of Regulatory Affairs, Lance has served as a Level III Certified Drug Specialist, Pre-Approval Manager, and presently, a Compliance Officer in ORA’s Office of Pharmaceutical Quality Operations - Division IV. As a member of FDA’s ORA Pharmaceutical Inspectorate, he has performed complex domestic and international inspections of pharmaceutical, biotech, API, GLP, and compounding pharmacy facilities.

As an FDA Compliance Officer, he interprets and applies the Food, Drug, and Cosmetics Act; advises various industry officials on official rules and regulations; and determines the most suitable course of regulatory action to protect and promote public health.

Prior to joining FDA, Lance worked in the pharmaceutical and genomics industry. He holds a B.A. in Integrative Biology from University of California at Berkeley and M.B.A. from the University of Phoenix.



Annual Sponsor:


FAQs

How can I contact the organizer with any questions?

You can contact the event organizer sending an email to rsvp@wccpda.org, please allows few days for the respons.

Is my registration fee or ticket transferrable?

Yes, thicket is not reboundable, however you can transfer it to whoever would like to attend in your behalf

My company would like to become a WCC PDA Sponsor, do you have a sponsorship program?

Yes, our WCC PDA Sponsorship Program offers a unique opportunity for companies that want to strengthen brand image, increase visibility, and gain access to leaders of the San Francisco Bay Life-Science Community

What is the dressing code?

Business casual


Cancellation Policy:
Dinner seating is confirmed and reserved in advance. We regret that no refunds can be offered for non-attendance. If a registrant cannot attend, substitutions are welcome. The chapter reserves the right to cancel a dinner meeting if the minimum number of attendees is not met by Monday prior to the event.

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Date and Time

Location

WellsFargo Event Center (To be confirmed)

333 Market St

Annex Building

San Francisco, CA 94105

View Map

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