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Do you fully understand and appreciate how the work that you do helps keep your company remain compliant with federal regulations? Would you like a well-rounded educational background necessary to work more productively and accurately in regulated industries?
Overview
Compliance to federal regulations such as those established by the Food and Drug Administration (FDA) determine the basic working operations within regulated industries. North Hennepin Community College (NHCC) has recognized the need for all employers to have a basic understanding of these regulations and has initiated and developed a non-degree Regulatory Affairs program designed to make individuals aware of federal regulatory requirements and the impact of these requirements on their work environment and their work activities. NHCC"s program ties together the many aspects of the regulatory process in order to provide an individual with a context for their daily activities. This approach benefits the company because employees better understand how their role helps the organization remain compliant with federal regulations. The course does not train individuals in any specific form or procedure. Rather, it trains employees in the generally accepted guidelines in order for them to have a well-rounded educational background necessary to work more productively and accurately in regulated industries.
As Minnesota bioscience companies grow and mature, the need for all employees to be knowledgeable in regulatory affairs has intensified. Employees at every level of regulated industry are critical in ensuring compliance with the federal regulations that guide the activities in the FDA-regulated industries. A recent Minneapolis Star Tribune article speaks to this issue.
Objectives
- To provide familiarity with the language and utilization of the Code of Federal Regulations through highlighted review and case studies for industry
- To understand the impact of regulation during the life cycle of products from design to post market
- To provide an understanding of the implications of non-compliance
Who Should Attend
The program is intended for new and current employees at any level within an FDA regulated industry who want to play a larger role in regulatory affairs matters within their organization.
Key Topics
- Regulatory Affairs: An Introduction
- History of the FDA and the creation of the Code of Federal Regulations for Medical Devices and Pharmaceuticals
- Good Laboratory Practices
- Good Manufacturing Practices
- Good Clinical Practices
Benefits of Attendance
The course taught by industry leading professionals from pharmaceutical, medical device, biologics and food industries to include representatives from Medtronic, University of Minnesota, Boston Scientific, Integra Group, FDA and independent industry consultants. On-the-job training. Use of relevant, real-life examples. Practical, immediately applicable information. Thirty-two hours of in-depth instruction delivered in eight four-hour evening sessions.
Quantity Discount
Employers receive a ten percent (10%) discount when three 93) or more company employees register for all four sessions as a group.
Comments From Past Program Participants
"I really enjoyed the examples the instructor gave. I have a whole new appreciation of regulations."
"Excellent, very well thought program. Instructors were very experienced in their respective fields. I would really recommend the class to anybody."
Upcoming Course Dates will be posted here soon. Program starting again in September 2010.
Take the next step and get started today by calling the Regulatory Affairs program manager, Robert Boettcher at 763-424-0880.
Cancellation Policy
NHCC understands that circumstances may arise that will necessitate the cancellation of a program registration. If a registrant must cancel out of a program, the following policies will apply:
- Cancellation must be received in writing
- You may cancel a program six (6) or more weeks prior to the start of a program without incurring a cancellation fee
- Because NHCC programs require significant advance preparation and also incurs costs for pre-course materials, the following cancellation fee schedule applies when the cancellation is received:
- Two (2) to six (6) weeks prior to program start - 50% of program fee
- Fewer than two (2) weeks prior to program start - 100% of program fee.
Programs, program dates, and faculty are subject to change and/or cancellation. In the event a program is cancelled by NHCC, the registration fee will be fully refunded. HNCC is not responsible for reimbursing travel related or other expenses incurred by program registrants if a program is cancelled.
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