Featured Instructor

Specialties: Manufacturing, Regulatory, R&D

Mr. Kerry Potter

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.

Courses:

CfPIE also offers the widest range of pharmaceutical and medical device certification programs designed to enhance career advancement.  Presently, over 3500 individuals are enrolled in Certification Programs covering GLP, GMP, Clinical Compliance, Process Validation, Global Regulatory Affairs, Document Management, QSR and CMC.  Over 1200 have already completed Certification and advanced their careers. 

In addition to the 300+ public courses offered annually, CfPIE is also the leading provider of on-site customized training to both industry and regulatory agencies around the world.  Customers have included the FDA, NIH, EMA, US Defense Department, Saudi FDA, as well as numerous European based national regulatory bodies. 
 

Pharmaceutical Training Courses

Our life science and pharmaceutical training course instructors frequently deliver FDA regulatory training topics designed to enhance inspection readiness, study design, clinical trial management, CMC guidance, computer system validation and the latest developments in medical device compliance.

CfPIE Frequently Asked Questions

Accounts & Registration

Q: Why do I need to create an account with CfPIE? I never had to create an account before.

A: Accounts are a new feature on our website. Creating a CfPIE account helps you view registration history and manage your training programs. All CfPIE course attendees must create an account. You must create an account even if you have taken classes with us in the past.

Q: How do I create an account with CfPIE?

A: When you register for a CfPIE training course, you will be prompted to create an account.

If you are registering yourself only, once you create an account you will be able to complete the checkout process.

Q: I would like to register myself and other people from my organization for a training course. How can I do this?

A: If you are registering yourself and other colleagues from your organization for a training course, please set up an account for each individual who is attending. This will allow that individual to access their account and track their training history.

Q: I am registering people other than myself for a training course. How can I do this?

A: If you are only registering other colleagues from your organization for a training course, please set up an account for each individual who is attending. This will allow that individual to access their account and track their training history.

Discounts

Q: What kind of discounts do you offer?

A: We offer Early Bird, Group, and Multiple Course Discounts. Visit our discounts overview page to learn more.

Classroom Training

Q: What is included with the cost of my classroom course?

A: The course tuition covers the course itself, materials, breakfast, lunch and break-time refreshments. Class fees DO NOT include accommodations, airfare or other travel costs. However, we do have negotiated rates with hotels that host our courses – see below for a list.

Q: Where are your classroom training sessions held?

A: CfPIE courses are conveniently located near major airports and transportation to and from the course site is readily available. Please consult our course locations and transportation page to find the airport closest to you.

Q: What time does my classroom course start/finish?

A: On the first day of class, check-in begins at 8:30am, with the course starting promptly at 9:00am. In most cases, our two-day courses run from 9:00 am to 5:00 pm each day. Most of our three-day courses run from 9:00 am to 5:00 pm on the first two days and from 9:00 am to 3:00 pm the third day. Classroom hours will be listed in your "Registration Confirmation Email". When booking your return travel, we strongly recommend that departures be scheduled at least two hours after the course ends on the final day. Thus, please do not make your flight arrangements until your "Registration Confirmation Email" is received as some of our course times vary slightly.

On-Site Training

Q: What is the minimum number of people needed to secure an on-site training?

A: A: We offer on-site training for organizations who have 10 or more attendees. In most cases, it is economical to bring a course on-site only if you have 10 or more who need training. Our On-Site Course Fees are based on the length of the course.

Certifications

Q: How do I become Certified??

A: To obtain your certification, all you need to do is participate in three core courses and one elective course related to one of our 13 certification tracks (https://www.cfpie.com/content/programs.aspx).  Once you complete the four courses, take the corresponding examinations and maintain an average minimum score of 70 percent, CfPIE will issue your certification credentials.

Q: How much does certification cost?

A: The total cost of certification is dictated by which individual courses you select and when you register (per our discount programs). There is no additional charge for certification above the standard course fee.  All of our courses are either two or three days in length.  The two-day courses are $1950 and the three-day are $2650.  There is a $200 discount available per course if you register more than 30 days in advance or register for more than one course at a time.

Q: How can I participate?

A: Simply register for and attend the course, complete the exam and let us know which Certification Track you'd like to be enrolled in.

Q: Where do I take the exams?

A: Exams are made available on-line once the course is over.  We will send you a link to the exams via email on the last day of the course. A history of your training and exams scores will be available when you access your account via our website. Individual course Attendance Certificates can also be printed from your account.

Q: How long is my certification good for?

A: Currently, we do not have an expiration date for our certification programs.

Q: Do I have to complete the courses in a certain amount of time?

A: No, but we suggest completing all four courses in a maximum of two or three years as courses are constantly updated to reflect changes in industry The average time taken to achieve Certification is 18 - 24 months.

Q: If I have already taken a course within the certification curriculum, can I take the test and have it count towards certification?

A: Yes, but only if you took that course within the last twelve months as our course content changes frequently.

Q: I noticed that some of the courses are too basic for me. Can I "test-out" of some of the more entry-level courses?

A: Yes, you are allowed to "test out" of ONE course for any certification track. However, you must attend three courses and complete the accompanying tests before "testing out" of the final course.

Cancellation Policy

Q: What is your cancellation policy?

A: Attendee Cancellation Policy – Classroom Courses
All cancellations must be in writing and are subject to a $350.00 cancellation fee. If cancellations are made more than 30 days prior to the course, a refund less the cancellation fee will be provided. If cancellations are made less than 30 days prior to the course, a voucher good for attendance at an upcoming course will be provided. The voucher, which can be used by the registrant or anyone else within his/her company, will be valued at the registration fee minus the $350.00 cancellation fee.

If a registered attendee does not cancel and fails to attend, neither a refund nor voucher will be issued. All course cancellations must be in writing and emailed sent to info@cfpie.com. Registrants are responsible for contacting the hotel and canceling their room reservations. CFPIE reserves the right to alter the venue, if necessary.

Substitution Policy – Classroom Courses
Substitutions are accepted at no penalty with written notification from the original registrant in advance of course. All substitution requests must be in writing and emailed to info@cfpie.com.

  • This course was FANTASTIC, and the materials were more comprehensive that other trainings!  The director was extremely knowledgeable and had clear answers to all our questions.  The director’s experience is apparent and it’s refreshing to have training from an expert.  I wish she worked for our company!
  • Excellent course, very thorough, good tempo and excellent resources provided.”
  • This was a superior training course compared to ones I have taken with other training companies.  The course director was knowledgeable on the topics and was able to engage the participants and challenge thinking norms while being very mindful of regulatory compliance.  There are no improvements needed to this course!”
  • This course was customized and delivered on-site and the Director was able to use her experience and expertise to answer questions that were specific to our company’s operations.  It was definitely a good use of my time (this has not always been the case with courses from other providers).”
  • The Course Director was one of the best presenters I have ever encountered and is extremely knowledgeable.” Craig, Operations Compliance Team Leader, MTF
  • This is the BEST course I’ve ever taken!  Material was very detailed, very well structured and supplemented with lots of examples.  The only drawback was it was only 2 days, I would have hoped longer!” Jiangyin B., Manager, Millendo Therapeutics
  • I really enjoyed this course!  It covered all aspects of aseptic processing with good case studies/examples.  Instructor was engaging and knowledgeable.” Veena P., Associate Director, Drug Product Development, CMC, Cerus Corp.
  •  “The combined knowledge and experience of the instructor was excellent.” Dominique S., Chemist, Alchemix
  • This course was great and more on-topic than courses I’ve taken with AAMI.  I enjoyed the clever way the material was presented.” Rachel H., Senior Quality Systems Specialist, ConvergeHEALTH