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Customer Testimonials
Nice response to my questions and good suggestions for moving forward.

Some of these sessions are too basic - this one had a good mix of basic and details. The tips are helpful. One comment: a little more discussion regarding the use of Detection in FMEAs would be useful since many do not advocate its use. Thanks,

I especially liked that the Q&A session after the webinar was long enough to not only address my own questions but also to learn from the questions from the other participants in the webinar.

Very thorough understanding of the history/progression of the guidances, and very helpful evaluation of current and potential directions. Excellent presentation skills, very engaging.


 Speaker Profile


Kerry Paul Potter
President, Summit Consulting, Inc.

Kerry gained his pharmaceutical manufacturing experience during his 28-year career with Merck. His career spanned the areas of Quality Operations, Audits & Inspections, Laboratory, Human Resources, and Learning & Development. More specifically, his responsibilities included quality management of laboratory assessment, site GMP lead auditor, FDA QSIT/Quality Management System manager, 5S coordinator, GMP trainer (annual, ongoing, new hire), OSHA regulations and Process Safety Management training, as well as internal and external public relations.

Kerry is a graduate of James Madison University in Harrisonburg, VA (B.S. in Chemistry) and is an advanced Toastmaster. He has received qualifications and certifications in the areas of facilitation and training, including competency-based curricula. His past affiliations have included ASQ, ASTD, PDA, GMP-TEA, ASPI, and AQP. Kerry is the founder of Summit Consulting, Inc. and has been assisting firms in the areas of remediation and project management within the manufacturing and the laboratory functions for the past two years.

 Upcoming Webinars
Do's & Don'ts during FDA Inspections
The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control. The key to a successful audit is being able to communicate how your quality systems assure this state of control.
Live  Wednesday, June 26, 2013 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$225.00

Pharmaceutical Manufacturing Batch Record Review
The FDA and its European counterpart, EMA, require drug manufacturers to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.
Live  Wednesday, July 10, 2013 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$225.00

Root Cause Analysis
This course provides clarification of the competencies to plan effective, efficient and thorough investigations and design a process for the successful elimination of recurring failures and deviations.
Live  Tuesday, July 30, 2013 10:00 AM PDT | 01:00 PM EDT,  Duration:60 Minutes
$225.00
...more
 Recorded Webinars
Pharmaceutical Manufacturing Batch Record Review
The FDA and its European counterpart, EMA, require drug manufacturers to have written procedures in place to document production and process controls, better known as batch records.
Recorded ,
$295.00

Good Documentation Practices for GMP Operations
Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance.
Recorded ,
$295.00

FDA Inspections - Do's & Don'ts
The purpose of the FDA inspection is a verification activity that should demonstrate to the regulatory agency and provide assurance that products consistently meet quality expectations and that your company is operating in a consistent and compliant state of control.
Recorded ,
$295.00

Good Documentation Practices in a Regulated Environment
Whether you work in production or in a laboratory or if you conduct investigations or finalize product release, sound data and information is essential to success and compliance.
Recorded ,
$295.00

...more


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