B102 - Introduction to the Biomedical Industry

Overview

This is a Primer for introducing interested parties to the Biomedical industry, its Regulations and culture. It can also help in Career Transition from technical industries to the biomedical and other highly regulated industries.
This class covers major Biomedical industry segments, e.g., Biomedical devices, Biotechnology, Pharmaceuticals, Health Care and Food regulation. It includes Biomedical industry vocabulary and a Review of regulations in the Medical Device, Biotech and Pharmaceutical and Food regulation fields. Students will have practice exercises in interpreting regulations. There will also be an opportunity for help in developing a transitional resume to attract an invitation for an interview in the biomedical industry.

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Instructor Marieann Shovlin

Instructor Bio

Marieann Shovlin is the founder of Peak Process, a company dedicated to optimizing organizational performance through collaboratively developing processes, implementing quality systems, and achieving continuous improvement goals. With over 25 years experience in high tech, primarily in senior management roles, she has worked in the biomedical device, telecommunications, and software industries. She is recently retired as Director of Quality for a local biomedical company and is currently consulting in the field.

As a consultant, Marieann has worked with organizations to design and document systems and processes to meet organizational goals. Her methodologies include a combination of proprietary tools and participative methods, all based on Systems and TQM theoretical foundations. She has developed and delivered training programs in quality management systems: ISO 9001:2000, ISO 13485:2003 and Quality System Implementation, customer satisfaction, biotechnology job search methods, and continuous process improvement for industry and non-profits. She is a ASQ Certified Biomedical Auditor (CBA), a Senior member in the ASQ (American Society for Quality, Silicon Valley Section), and has served as past Chair, Program Chair, ENEWS Editor, Education and Marketing Chair.

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Course Times

8:00 a.m - 5:00 p.m.

Lunch Break: 12:00 - 1:00 p.m.

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Course Details

Prerequisites: None

Hardware: N/A Software: N/A

Required Materials:

- Proof of online Payment

- Pencil & Paper or laptop/tablet if you prefer

- If you are an ASQ member, a current-dated ASQ Membership ID

- Valid ID(s): sites may require US citizens to provide a Driver's License or a State-Issued ID; if you are not a US citizen you must bring 2 valid forms of identification

Learning Method: Lectures, teams, case studies, hands on approach

Class Time: 8 hours

Class Size: 25 max. participants

Facilities: Room with PC projector, whiteboard, etc.

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