Since 1998
Publications
Our Training Manuals
To purchase a copy, please visit our
Merchandise page
The fourth edition of
Medical Product Risk Management Training Using HACCP Principles
is now available.

The second edition of
Pharmaceutical Risk Management Training Using HACCP Principles
is now available.

Older editions of our training manuals are also available at reduced prices.
Other HACCP/Risk Management related publications
HACCP for Medical Devices - by CAPT Joseph L. Salyer, RS, MPH. (originally published by Medical Device Summit)
Service Solutions: Mitigating Risks in Service - by William A. Hyman, ScD, PE.
HACCP: Resolving Product Safety and Liability Nightmares - by Lorena L. Williams, The Chubb Group of Insurance Companies.
The Application of HACCP in Clinical Engineering - by William A. Hyman, PhD. Biomedical Dept., Texas A&M University.
Standard Practice for the Application of HACCP to Medical Device Manufacturing - by William A. Hyman.
Medical Industry Adopts Seafood HACCP as a Model of Quality Assurance. This is a press release dated November 25, 2002.
Download a letter to Edward R. Kimmelman, BME, JD containing proposed changes for the ISO 13485 document which have been suggested by the Medical HACCP Alliance Board.
Hazard Analysis and Critical Control Point (HACCP) for Medical Products brochure. Learn how HACCP relates to medical products.
Implementation of Hazard Analysis and Critical Control Points (HACCP) Plan as a Continual Improvement Initiative in the Manufacturing Process of Medical Devices - by Victor Oparah.
Mr. Oparah presented this paper to the Graduate faculty of the Massachusetts College of Pharmacy and Health Sciences in partial fulfillment of the requirements for the degree of Master of Science. He can be contacted at voparah@excite.com.
HACCP Week PowerPoint Slide Show 1 courtesy of Cyberonics HACCP Program Committee.
HACCP Week PowerPoint Slide Show 2 also courtesy of Cyberonics HACCP Program Committee.
Hazard Analysis and Critical Control Points (HACCP) A Study for Medical Device Manufacturing - HACCP Team, Adrianne Galdi, Team Leader, Center for Devices and Radiological Health, Food and Drug Administration.
A basic HACCP plan form to help create your HACCP plan. To download in MS Word format, click here.
A basic hazard analysis worksheet to help you properly analyze your operation. Note: this is different from but goes with the HACCP plan worksheet above. To download in MS Word format, click here.
A hazard analysis worksheet with decision tree. To download in MS Word format, click here.
If you participate in any training, seminars, speeches, etc. related to HACCP please send Laura Douglas (Email: medicalhaccpalliance@yahoo.com and/or grma@globalriskmanagementalliance.com) a brief description of the meeting, etc. (One or two paragraphs would be great.) The Alliance would like to list such information on the HACCP webpages and give you some recognition for your efforts and support of HACCP. Also, it may be possible to have your presentations on the Alliance webpage for review.