Course Description - Course runs 9:00 - 5:00 on Day 1 & Day 2 -- 9:00 - 3:00 on Day 3 (Breakfast & Lunch Included)

Inadequate failure investigations continue to be a major GMP deficiency cited during routine and for-cause regulatory inspections. This course highlights FDA and EU regulations and how to successfully approach a failure investigation and engage in subsequent root cause analysis.

The primary objective of this course is to recognize the value of conducting proper root cause analysis and documenting failure investigations. Emphasis is placed on the application and practical, hands-on aspects of how to facilitate root cause analysis. Additionally, the course will provide attendees with the principles and techniques involved in identifying failures and deviations, categorizing problems, assigning responsibility and tracking team activities.

Additional benefits of this class include:

• Learn not just from the Director, but tap into the knowledge of your peers: Participants will have the opportunity to anonymously submit their challenges, problems, and issues for classroom discussion. Ample time is provided to address specific problems and questions of individual participants
• Explore the use of brainstorming, process mapping and regulatory resources
• Participants will also have the opportunity for one-on-one consultation with the Course Director during course breaks and in the evenings

Who Should Attend

This Root Cause Analysis training course is designed for personnel who are responsible for the failure and deviation investigation process in a GMP environment, specifically Root Cause Analysis for CAPA. These include, but are not limited to, positions in Manufacturing and Packaging, Quality Assurance/Quality Control, and those support groups who initiate, conduct and/or manage investigations in a pharmaceutical, clinical manufacturing, biologics and medical device environment. This course will be practical in its application and particularly valuable to those newer to this field or those who wish to refresh their knowledge of root cause analysis and investigative techniques.

Mr. Kerry Potter

Specialties: Regulatory

Mr. Kerry Potter is the founder of Summit Consulting, Inc. He has more than 30 years of experience in project management, regulatory compliance systems, quality assurance, quality systems audits, regulatory training, employee development, GMP and documentation.

During the past 10 years, Kerry has provided consulting, training and mentoring services to several pharmaceutical firms in the United States and Europe through regulatory remediation activities (e.g. Consent Decree, Warning Letters), training and training systems development, documentation control, and project management.

Mr. Potter gained his pharmaceutical-manufacturing experience during his 28-year career with Merck. His experience spanned quality operations, audits/inspections, laboratory, human resources, and learning & development. His responsibilities included quality inspector, analytical chemist, quality motivation administrator, laboratory quality-management assessment manager, GMP lead auditor, FDA quality-management system manager, 5S coordinator, GMP trainer, OSHA regulations trainer, process safety management training, and internal and external public relations management.

Mr. Potter received his B.S. in Chemistry from James Madison University. He has received qualifications and certifications in quality auditing, facilitation and training – including instructional design and competency-based curricula. His past and current affiliations include ASQ, ASTD, PDA, GMP-TEA, ASPI and AQP.