Track 2: Laboratory

Monday 14 November 2011 - Tuesday 15 November 2011

There Are Common Threads in Many Compliance Problems Experienced in the Laboratory. Do You Know What They Are?
Validation of a computerised system is just as critical in a laboratory as it is in manufacturing. Gain a better understanding of what the Regulatory Agencies are looking for in relation to Quality Systems. Learn through case studies and get immediate feedback from subject-matter experts and regulators on how to take a risk-based approach to the validation of laboratory computerised systems with GAMP®5.

Winnie Cappucci
, PS Compliance IT Systems NA, Bayer Healthcare - retired (USA)
Michael L. Rutherford, Quality Consultant - Laboratory Information, Eli Lilly & Company (USA)

Monica Cahilly, President, GMQA, LLC (USA)
Judy Samardelis, Associate Director of Computer & Software Validation, QIAGEN (USA)
Robert D. Tollefsen,
Consumer Safety Officer, National Expert-Computers Pharmaceutical Inspectorate, FDA (USA)

At the conclusion of this session, participants will be able to:
Apply new risk-based concepts related to laboratory systems validation as presented in the new GAMP®Good Practice Guide.

Who Should Attend?
GAMP®COP, Laboratory Managers, Scientists, Quality Assurance Professionals.

Download the Registration Form for this Conference here! ( 42 KB)

Latest Agenda:

Monday 14 November 2011
9:30 10:30 Keynote Address
10:30 10:50 Refreshment Break
10:50 12:30 Keynote Address
12:30 13:30 Lunch and Networking Break
13:30 13:40 Welcome and Introduction to the Laboratory Track Session
Michael Rutherford, Eli Lilly (USA)
13:40 14:20 Laboratory GPG Version 2 - Overview
Mark Newton, Eli Lilly (USA)
14:20 15:00 Validation productivity / Efficiency Improvement - Overview and Case Study
Judy Samardelis, Qiagen (USA)
15:00 15:30 Networking Break
15:30 15:50 Supplier / Vendor Management - Overview and Introduction to Workshop
Mark Newton, Eli Lilly (USA); Michael Rutherford, Eli Lilly (USA)
15:50 16:50 Supplier / Vendor Management - Workshop
Mark Newton, Eli Lilly (USA); Michael Rutherford, Eli Lilly (USA)
16:50 17:00 Session Summary
17:00   Session Adjourns
Tuesday 15 November 2011
8:00 8:10 Welcome and Agenda Review
Michael Rutherford, Eli Lilly (USA)
8:10 8:30 Laboratory Quality Systems - Regulatory Concerns
Robert Tollefsen, FDA (USA)
8:30 10:00 Introduction to Data Integrity Issues and Introduction to the FTIR Instrument Case Study
Monica Cahilly, GMQA (USA); Robert Tollefsen, FDA (USA)
10:00 10:30 Networking Break
10:30 12:00 FTIR Case Study - Controls for the FTIR Systems to Mitigate Data Integrity Risks
Monica Cahilly, GMQA (USA); Robert Tollefsen, FDA (USA)
12:00 13:00 Lunch & Networking Break
13:00 13:45 Data Integrity Issues and Current Regulatory Concerns for Chromatography Systems
Monica Cahilly, GMQA (USA); Robert Tollefsen, FDA (USA)
13:45 14:30 Round Table Discussion / Q&A
Monica Cahilly, GMQA (USA); Robert Tollefsen, FDA (USA); Michael Rutherford, Eli Lilly (USA)
14:20 14:30 Session Summary
Michael Rutherford, Eli Lilly (USA)
14:30   Session Adjourns
14:30 15:00 Networking Break
15:00 17:00 ISPE GAMP Conference - Plenary Session

Conference Highlights:

Monday 14 November - Tuesday 15 November 2011

In honour of our 20th Anniversary of GAMP®, ISPE is offering 20% off all GAMP®Guidance Documents in the Guide Series to ISPE Members*.

*Guidance Documents will not be on site. You will be able to complete the order form and ISPE will ship your order to you. If you cancel registration to the conference after purchasing any GAMP Guide(s) you will be charged the full Guidance Document price. 20% discount applies to ISPE Members only.