Re: Certified Biomedical Auditor(CBA) exam preparation material
Thanks Ajit
The reason for asking or suggestion, becasue I have seen some folks try to scare, I believe misleading. Every one has different views. IN ASQ forum one guy mentioned 10 different books. Where as according to other hand book is sufficient.
As you suggest King01, "Everyone has different views" and when you ask for opinions that is what you get. No one can tell you what to do.
A few things that you may want to know about the CBA:
1. In 2004 when I took the exam, it was known as the CQA-Biomedical which meant that you had already demonstrated auditing expertise by passing the Certified Quality Auditor (CQA) and were seeking recognition for your understanding of the Biomedical-industry or medical device regulations and principles & practice.
2. Now that it is a "stand-alone" certification, the CBA candidate needs to demonstrate auditing capabilities on the CBA exam. Recommended references include The ASQ Auditing Handbook, Third Edition, or The Quality Council of Indiana's (QCI's) CQA Primer.
3. If you refer to list of references for the CBA on the ASQ Certification website, you will find that many references are available on the web for free by following the links. Also, it is recognized that not every standard and reference listed is absolutely necessary to pass the exam. In terms of references, the CBA has been recognized as having one of the most extensive and diverse sources of information listed according to its Body of Knowledge (BOK). Your preparation will be based upon your experience and knowledge (or lack thereof) among the reference list. Also, please understand that this list remains applicable until the BOK is updated, usually on a five year interval. So, the questions on the exam may not necessarily reflect the most-current standards that have been introduced since the BOK was last updated.
4. As areas of cGMP include food, medical devices, and pharmaceuticals, you may be interested in the Certified Pharmaceutical GMP Professional which was recently approved by ASQ for development by Certification Offerings. I am unsure how long it will be before this new certification will be available. Also, for food, CHA (Certified HACCP Auditor) is also currently available.
5. I believe that the Biomedical Division is currently developing new materials for a CBA Refresher Course and/or handbook. However, these materials may also not be available for quite some time. The existing Biomedical Quality Auditor Handbook (BQAH) is written at a very general or high-level and may not contain an exhaustive amount of information on every subject within the BOK. It is a very useful reference, but the extent of the CBA BOK makes it impossible to be summarized in such a convenient package. The "free" materials in the reference list do not fit easily into a three (3) inch thick binder.
As you may know, the BQAH and the Auditing Handbooks sell to ASQ members for $66.15 US each or $110.25 US each at list on the ASQ website. At current, I haven't thought about selling these items as yet, but might consider any reasonable offer.