The American Injection Molding (AIM) Institute has announced the release of its latest educational offering to the plastics industry. The new course, Quality Systems for Medical Injection Molding, will be taught by John Anes, an independent consultant with over 30 years’ management experience in medical device development, manufacture and quality systems. The first course will be held in August of 2017 at AIM’s headquarters in Erie, PA.
This three-day course was developed for both OEM companies (the customer) and molding companies (the supplier) that are involved in the manufacturing of medical devices. The course covers regulatory requirements, referencing FDA (21CFR) and ISO (13485) standards. Included in the course will be information on the steps involved to achieve ISO certification. The course material covers a review of documentation requirements for part and mold design, instruction on mold/process validation, and document control requirements for injection molding. An emphasis on critical areas of the Quality Management System will include review of the Device Master Record, product acceptance, calibration, employee training, material traceability and product non-conformance. Completion of the course gives companies detailed methods to compete at a higher level by implementing process systems that will improve product quality and company performance.
The American Injection Molding Institute was founded by Professor John Beaumont who helped develop and chaired the Plastics Engineering Technology program at Penn State Erie. In 2014, after 25 years, Beaumont retired from the University. Beaumont then turned his focus to developing the AIM Institute. The AIM Institute exists to be a leading educational and research resource for the injection molding industry and its practicing professionals. When asked why the AIM Institute had decided to add the Quality Systems for Medical Injection Molding course to their program Beaumont responded, “We regularly work with companies that are involved in the development of medical devices. Through this interaction we realized that our industry would benefit from a course focused on medical device manufacturing.” Beaumont also stated that, “This industry specific course is the first of many that will be offered by the AIM Institute.”
For more information on the Quality Systems for Medical Injection Molding course and all of the AIM Institute’s courses please visit the website, www.aim.institute or call 866-344-9694.