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
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 Varvaryan, Quality 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.
- $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
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)
Please park in the Prolacta parking lot.
For additional information about the Southern California Chapter event, please contact Sheba Zaman.
Exhibits and Sponsorship
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.