Issues to be covered 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 training course has been developed for those who are involved with ensuring regulatory compliance for medical devices. The course is primarily geared towards those who are new to industry or require a basic understanding of medical device regulatory compliance issues. The training may be of interest to industry veterans who need refresher training on these topics.
Typical attendees include those in:
Introduction to FDA
Product Approval Processes
FDA Reporting Systems
Enforcement Tools and Actions
Question and Answer Session
Quality System Orientation – 21 CFR 820
Quality System Inspection Technique (QSIT)
Quality Risk Management
Do's and Dont's
Why Systems Fail
"The Course Director is extremely knowledgeable and a true subject matter expert. She presents the material in a pleasant way and with meaningful practical examples." Melissa N., Sr. Clinical Study Mgr., Allergan "OUTSTANDING!!! Excellent class, great delivery, awesome overview. Thank you!" Eugenia T., Sr. Manager, R. J. Reynolds "This course was very useful to me to get a better understanding of FDA and quality systems from the viewpoint of our clients. I feel my lab quality manager would benefit from this course greatly. I appreciated the knowledgeable examples that helped to explain concepts more situationally, rather than just explanation of topics. It was useful to wrap my head around brand new concepts." Julia V., Area Manager - Medical Device Unit, Menasha Packaging Corp. "Good course. Gave me a handle on the issues of regulator compliance." Manan H., Clinical Regulatory Manager, Infinite Biomedical Technologies
"Very useful as an overview. I was able to get a good feel for the important issues from the FDA perspective." Kristen I., Assistant Manager, Business Development, Panasonic Shikoki Electronics
"Very good course to introduce me to the world of medical device regulation and compliance. The class size allowed for very good instructor/participant interaction." George P., Global Registration Manager
"This course provided a great overview of a number of different areas, all of which pertain directly or indirectly to my current position" Diana S., Compliance Specialist, Terumo Medical Corp.
"I feel like I have an understanding of the concepts from this course. Thank you so much!" Melissa M., Quality Technician, Apothecary Products, Inc.
"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
"The Course Director provided a wealth of information. Her expertise and extensive personal experience was valuable to teaching the class. She was available for questions and provided excellent examples." Heather D., Siemens Medical
"Course director was extremely knowledgeable. Presented subject matter with diagrams which provided extremely comfortable understanding." Jacqueline E., Update Specialist, Siemens Medical
"Excellent delivery; organization of materials. Instructor went above and beyond in course presentation and audience engagements. It was fantastic…thank you!" Stephanie S., RA Specialist III, Dentsply Specialty Materials
"This was a very good all-around course. It provides useful information for all levels of QA experience." Mary M., QA Supervisor, Skytron
"Being new to the medical device industry, this was a good overview from the regulatory perspective. The knowledge gained will enhance my daily activities." Lynda S., Quality, Manager, Documentation & Labeling, Teleflex Medical
"I've had this course director before and was very happy to have her again. She is very engaging and encourages participation. She is very knowledgeable and very professional. I hope to have her again in the future." Randy M., Quality Engineer, Orasure Technologies, Inc.
The Product Approval Process section is a higher level overview of the types of approvals and to which devices they may be applicable. Specific instructions for each type of submission are NOT covered in the class.
LinkedIn provides connections to various medical device groups. Keywords "device" or diagnostic" can be used to begin the search. The FDA Inspections Group provides current content based on FDA inspections. CfPIE also has a LinkedIn Group which is a forum for professionals to share industry-active topics. The FDA Law Blog (http://www.fdalawblog.net/) covers patent issues, drugs, and other issues outside of only medical devices.
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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