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Pharmaceutical Production Batch Record Review | Training

  January 22, 2018  
CfPIE - The Center for Professional Innovation & Education, Boston, MA USA
September 24 & 25, 2018

Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

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.

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.

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

Who Should Attend

This two-day course is designed for pharmaceutical production, quality assurance and compliance personnel who are responsible for the review and audit of production batch records, and batch record deviation investigations. This includes, but is not limited to, such positions in Quality Control, Quality Assurance, Manufacturing, and Packaging groups. Those who supervise, manage, or oversee these activities would also benefit from this program.

Organized by: Center for Professional Innovation & Education
Invited Speakers:

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.


Deadline for Abstracts: N/A
Registration: https://www.cfpie.com/ProductDetails.aspx?ProductID=247
E-mail: info@cfpie.com
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