Efficient and effective batch record reviews provide pharmaceutical companies with two strategies. First, reviews are key to maintaining control of your firm’s operations, eliminating any guesswork and aiding in the resolution of atypical occurrences. Secondly, they enable a company to maintain and demonstrate a compliant posture - a sure way to avoid any quandary with the regulatory agencies.

This course is intended to take the mystery out of the batch record review process. The class examines the FDA and EU regulatory requirements for documentation and batch record reviews, explains the elements of the batch record review process, and clarifies the pathway to effective deviation investigations. Interactive sessions are included for identifying reviewer responsibilities, establishing good documentation practices, and writing procedures for the review process. Additionally, participants will be able to analyze their company’s compliance with these requirements and identify missing elements of the batch review process.

Ample time is provided to address specific problems and questions of individual participants. 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
• Participants will also have the opportunity for one-on-one consulting with the course director during course breaks and in the evenings. The course director has over 25 years of industry experience

This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.

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.