Featured Instructor

Sean Develin

Sean Develin
Specialties: Regulatory

Sean Develin – with nearly 20 years in regulated industry – is co-founder of DevRose Systems. This UK and US-based consultancy provides information technology, validated cloud, auditing and compliance services to regulated clients worldwide. He is also an adjunct faculty member of the Temple University School of Pharmacy; where he teaches Bioethics, Auditing and Validation.

Prior to launching DevRose Systems, Mr. Develin built and managed the validation practice for Falcon Consulting Group and was Director of Validation for Omnicare Clinical Research. His expertise ranges from human research protections to vendor management and data integrity. His work has been extensively audited by regulatory agencies, study sponsors and hosting clients.

 

COURSES:

About Us

CfPIE provides pharmaceutical training, medical device courses and certification programs for a wide variety of industry professionals.  Consistently recognized by regulatory authorities as the leading provider of high quality training across the globe, CfPIE utilizes highly qualified instructors who are outstanding leaders in their fields.  Courses cover a variety of topics including pharmaceutical GxP, medical device design control and validation, process validation for drugs, devices and combination products, as well as numerous courses covering a wide-range of regulatory affairs training and quality system instruction.

CfPIE training programs focus on the latest regulatory guidances issued by the FDA and EMA, as well as updates to FDA compliance and inspections involving GMP, GCP and GLP processes.  Much of our life science training and pharmaceutical training course program centers on how to avoid warning letters by ensuring that your operational guidelines meet the latest regulatory compliance. These courses range from medical writing programs, clinical trial design and management, QA/QC training, as well as CMC, biologics, biotechnology and clinical research.

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.

  • sThe industry experience the CfPIE Certification Program instructors share is impossible to find in any book. -Katharine M., Document Coordinator, Sanofi Pasteur
  • I have especially enjoyed the courses completed thus far because I was able to customize the certification classes to include topics that are associated with my current job responsibilities, which include management and establishment of QA programs to foster GXP compliance.-Linda B., Director, QA, Kowa Research Institute
  • The course provided an excellent basic overview of FDA regulation. One of the best medical device training courses I have ever attended!" — Ron B., Quality Manager, Johnson & Johnson
  • This was an excellent course. Definitely one of the best I have ever attended. The material was useful, presented well and very interesting.  — Pascale J., Technical Manager, Genentech
  • "Excellent, Top Tier! The course delivered new and useful information and clarified many of the unknown complexities of these CMC topics.  — Jim, T., Project Manager, Teva Pharmaceuticals
  • The course director was an excellent presenter. I am a project manager and took this course as a way to get an overview of the CMC— Karen B., Sr. Project Manager, Pfizer