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PDA Pacific Northwest Chapter: Demystifying the Audit Trail

Jun 25, 2019
Kirkland, WA

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Overview

The PDA PNW chapter was chartered in 2018 to provide a local forum through which technical professionals in Washington, Oregon, Idaho, Alaska and British Columbia could support the advancement of pharmaceutical and bio-pharmaceutical science and technology.

Since 2015, with the intro of the Data Integrity guidelines and the focus on data management and security, the audit trail has become a primary focus of inspections. Understanding your Audit trail and the ability to review the data contained in it is now essential to compliance. This PDA sponsored Dinner Event will feature Rob Lutskus, Associate Director of Commercial Operations and Bio-science Informatics at Lonza, who will be speaking on demystifying the audit trail in bio-pharmaceutical manufacturing. Mr. Lutskus' presentation will provide both recommendations on how to implement data integrity controls and examples of good vs bad audit trails, as well as offer tools to evaluate your systems for inspection readiness.

Enjoy drinks and appetizers with colleagues both old and new while learning how to implement data integrity controls into your quality system. Help us continue the successful PNW Chapter event season for our local PDA chapter and become a part of the rapidly growing PNW-based pharmaceutical and bio-pharmaceutical community.

Agenda

    • 6:00 p.m. Dinner/Networking
    • 7:00 p.m. Presentation/ Open Discussion
    • 8:00 p.m. Networking
    • 8:30 p.m. Closing

Highlighted Speakers

Rob  Lutskus
Rob Lutskus
Lonza Bioscience Informatics

Travel

Kirkland Women's Club

407 First Street
Kirkland, WA

Directions

Registration Fees

Regular Price
Registration Type Price by 18 June
PDA Member $60
PDA Non-Member $70
Student $20

Late Registration Price by 25 June
All Registrants $80



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