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PDA Southern California Chapter: Inspection Trends and Prolacta Facility Tour

Aug 16 - Aug 16, 2018 |
Aug 16, 2018 |
Prolactia Bioscience | City of Industry, CA
  • Chapter
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757 Baldwin Park Blvd, City of Industry, CA 91746

Agenda

5:00 PM Arrival and Check-in
5:00 PM - 6:00 PM Networking / Opening Comments
6:00 PM-  7:00 PM 2 guest speakers (30 minutes each includes Q&A)
7:00 PM - 7:15 PM Sponsor Introductions
7:15 PM - 7:30 PM Overview from Prolacta Bioscience
7:30 PM Tour A start
7:45 PM Tour B start
8:00 PM Tour C start
8:30 PM - 9:00 PM Philanthropy Announcement, Raffle, and Closing Comments

Presentations

Understanding Visual Inspection Process for Finished Goods - Prolacta A Case Study
Presented by Berj Varvaryan, Prolacta Bioscience

Preparation for Data Integrity Based Inspections
Presented by William Honeck, VTI Life Sciences, Inc.

About the Speakers

Berj VarvaryanQuality Operations Manager at Prolacta Bioscience

Beri has been with the company just over 2 years and currently oversees incoming milk/material inspections, manufacturing operations support (reviewing investigations, protocols/studies, change control, procedures and batch records), compliance entailing internal and external audits, and supporting the Quality Control Laboratory.

Prior to Prolacta, Berj was in the plasma industry at Baxter, where he spent several years in Engineering, specifically Critical Systems, and then transitioned to Quality Operations. He is happily married and has a 2-year-old son who takes up every second of his time outside of work.

Berj is very passionate about what Prolacta does as a company and is happy to contribute in some shape or form to help save the lives of the most precious and delicate human beings.

William Honeck, Vice President of West Coast Operations for VTI Life Sciences, Inc.

William has over 25 years of experience in the pharmaceutical, biotechnology, and medical device industries. Prior to joining VTI Mr. Honeck held senior positions within the industry including Associate Director positions within Validation, IT, and QA at Gilead Sciences, Johnson and Johnson, and Scios. He received a BSc Degree in Biochemistry from University of California, Davis. Mr. Honeck has led numerous validation projects while serving in Analytical Development, Quality Control, IT, and Quality Assurance capacities.

His expertise includes establishment of Quality Systems and validation project management, development of Validation Master Plans, validation SOPs, risk assessments, gap assessments, audits, and qualification protocols for computerized systems, utilities, equipment, and analytical instruments with a focus on data integrity. In addition, he has served as an SME in numerous Regulatory Agency Inspections.

Registration

  • $60 PDA Member
  • $75 Non-PDA Member
  • $40 Government
  • $40 PDA Student Member
  • $40 Tour Facility Host Company Employees

A late registration fees of $10 applies after August 9, 2018

Trouble registering online? Download the manual attendee registration form

Cancellations

NO cancellations after August 9, 2018

  • 100% refundable on or before August 1, 2018
  • 50% refundable between August 2, 2018 – August 9, 2018

Early Registration Fees (Submitted on/or before August 9, 2018)

Additional Information

Please park in the Prolacta parking lot.

For additional information about the Southern California Chapter event, please contact Sheba Zaman.

Exhibits and Sponsorship

Exhibitors, Register Online Here.

If you have questions about exhibiting at or sponsoring this event, please contact Tita Tavares.

Event sponsorhip includes: 6' foot table, company logo & description on all event marketing material w/hyper link to website, 1-2 minute vendor announcement during event, one admission ticket.

Trouble registering online? Download the manual sponsorship registration form here

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=4504

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