James L. Vesper, PhD, MPH, director of ValSource Learning Solutions, designs and develops instructional courses and workshops for the pharmaceutical and biopharma industries. Before joining ValSource in 2017, he established and is President of the firm LearningPlus, Inc. and has had more than 35 years’ experience in the pharmaceutical industry. Dr. Vesper worked 11 years at Eli Lilly and Company, first as a Corporate Industrial Hygienist, then in Corporate Quality Assurance, where he was responsible for issues concerning the manufacture and testing of parenteral products made at Lilly facilities and third parties worldwide. His last assignment at Lilly was as Project Leader of Good Manufacturing Practice (GMP) Education and Instruction, establishing the department and its mission.
Welcome and Agenda for the Day
Why Investigate?
Definitions and Models
14 Steps to Better Investigations
Summary/Wrap Up for the Day
Effective Root Cause Analysis and CAPA Investigations for the Life Sciences — Day 2
Welcome and Agenda for the Day
Conducting the Investigation: Tools to Help Identify the Causes and Contributors
Interviewing Skills
Working with Subject Matter Experts
What if You Can’t Find the Root Cause?
Summary/Wrap Up for the Day
Effective Root Cause Analysis and CAPA Investigations for the Life Sciences — Day 3
Welcome and Agenda for the Day
Assessing and Managing Risks Related to Investigations
Corrections and Corrective Actions (and Preventive Actions)
Writing it Up: Key Elements in a Report
Your Investigation System: What Will You Take Back and Do Differently?
Summary/Wrap-Up