Pharma / Biotech
This course is designed to provide participants with an understanding of the parameters for regulatory compliance, successful approaches to compliance, and meeting the concerns of regulators. Attendees will leave with a comprehensive set of tools for preparing regulatory initiatives, coping with challenges, and managing compliance.
Additional benefits of this class include:
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.
This course is designed to provide attendees with a strong foundation for understanding the regulatory requirements of the US FDA. The content is ideal for those looking for an introduction to regulatory compliance or who need a refresher on current compliance trends within the regulated environment.
Typical attendees include those in the following disciplines:
The course is ideal for new hires, as well as Managers, Directors, and Vice Presidents of Regulatory Affairs and Quality Assurance. All levels of experience will benefit from this course.
2. Interpreting Regulations
3. Audits and outsourcing
4. Management Oversight
5. Navigating FDA
6. Emerging Trends at the FDA
7. Drug Development and Approval Process
8. Successful Approaches to Compliance
Upon completion of the course attendees will:
"I have been provided with a better understanding of QA regulatory requirements, as they apply to my own processes. Also, I have acquired some ideas on how to implement audits within my group." Cleo N., Quality Control Officer/Acting Team Leader, Los Alamos National Lab
"The course instructor was excellent. She has a wealth of knowledge and applicable examples to share with the class. She allowed the class to go off topic, but in relation to the course overall." Sophia S., Manager Regulatory Affairs, Merrimack Pharmaceuticals
"Very engaging and knowledgeable instructor. Sharing of actual experiences and bench marking made the course educational and provided tools to improve compliance at my employer" Jeffrey W., QA Compliance Specialist, Bristol Myers Squibb
"I am very, very happy with the depth and detail of information provided by the instructors. I also feel that I was given the tools to continue to educate myself effectively in FDA regulations. I will definitely recommend this group to others seeking FDA regulation training." David G., Chemist, Blaine Labs
"The decision to attend the CfPIE course was one of the wisest decisions in my professional career. The Course Director was extremely knowledgeable and an expert in engaging attendees in the discussions. The subject matter was thoroughly covered. I would definitely recommend the course to others. I am looking forward to attending more courses with CfPIE. This course justified each and every dollar I spent on it." Hiral K., QA Associates, Apicore Pharma
"I felt that the instructor tailored the class to the needs of the attendees and requested the needs up front, which was very helpful." Karen K., Senior Director, Submissions & Product License Support, Pfizer
"The Course was well organized and supported well by the written material. The instructor was knowledgeable and illustrated numerous points by example. She appeared to be very current on FDA thinking." William M., Livestock Vet. Manager, Pfizer Animal Health
"CfPIE has once again delivered a course of the highest standard. The instructor relayed her best knowledge of the pharmaceutical and biotech industries in a comprehensive and energetic manner. I look forward to attending further courses with CfPIE in the future." Janet P., QCT, Pfizer
"This was and excellent class! The information gives you a very comprehensive overview of what the FDA requires. I was able to get more information from this FDA training class in two days than I have in all other training courses I have taken combined!" Cory D., Associate Manager, Document Control, Cardinal Health – Oral Technologies
"Very informative course. The Course Director takes the time to answer client-specific questions which really helps drive the information home." Claudia B., Senior Consultant, Tunnell Consulting
"Great introduction to the FDA inspection process and requirements from all perspectives. The Course Director's experience and knowledge is very applicable and evident." Scott G., Senior Scientist, Shire Labs "Presentation was clear and the Course Director showed a willingness to go beyond the material by giving real-life examples to help with understanding and clarification." Monica S., Senior QA Auditor, Merck
"The Course Director was very informative. Her ability to give examples based on personal experience really enhanced my learning and understanding of the topics." Kelli H., QA Manager, PharmaForm
"The course used numerous examples of personal experience and examples from FDA audits of biotech and pharma companies which was critical in effectively understanding FDA regulations, audits and quality systems. I have been able to make a direct comparison between my company's current quality systems and what the FDA expects to see. This has not only provided me with a degree of reassurance, but has also enabled me to think of new ideas. I intend to implement change within my own manufacturing department which will assist in the monitoring and control of current process and systems. The course has been very thought provoking and a fantastic refresher." Angela S., Reagents Manager, Genzyme Diagnostics
"Our instructor was very knowledgeable and very encouraging. Communication was excellent and she cared that we understood the course materials." Sarah V., Regulatory Affairs Compliance Analyst, Paddock Labs
Each person attending a course will be asked to set up an Attendee Profile Account during the registration process.
Accounts are a new feature on our website. Creating an Account helps you view your order history and manage your training programs.
If you are registering for others, please set up an Account in the Attendee’s name. If you are
registering more than one person, you’ll need to set up a separate account for each Attendee.
*Valid up to 30 days prior to course date(s). Cannot be combined with other discounts or offers.
The Center for Professional Innovation and Education (CfPIE) provides technical training for Pharmaceutical, Biotech, Medical Device and Skin/Cosmetics professionals. CfPIE offers more than 350 class sessions annually across 80 course titles in multiple formats, such as classroom, on-site and certification programs.
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