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

Mr. Kerry Potter

Specialties: Regulatory

Mr. Kerry Potter is the founder of Summit Consulting. 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 five years, Kerry has offered consulting and mentoring services to several companies through remediation activities, training and project management. In this time, he has assisted pharmaceutical firms worldwide in remediation and project management in quality systems, manufacturing controls and training functions for the past five years.

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

Mr. Potter received his B.S. in Chemistry from James Madison University. He has also received qualifications and certifications in facilitation and training – including instructional design and competency-based curricula.

Mr. Potter is currently ASQ Certified as a Quality Auditor. His past affiliations have included ASQ, ASTD, PDA, GMP-TEA, ASPI and AQP.