C
CertifiedDataJunkie
My current goals include successful completion of the ASQ CPGP exam before July 2011. As an ASQ Certified Biomedical and HACCP Auditor (CBA/CHA), it seemed like a natural progression to complete this GMP "trinity." However, I found its extensive reference list (https://asq.org/certification/pharmaceutical-gmp/references.html) and body of knowledge (BOK, https://asq.org/certification/pharmaceutical-gmp/bok.html) overwhelming when attempting this exam about two years ago when it was piloted.
Having successfully completed thirteen (13) other ASQ exams on the first attempt, I still believe that becoming better prepared can lead to the realization of this goal. About a year ago, I subscribed to ASQ's "Certified Pharmaceutical GMP Professional Question Bank," but found the questions much less rigorous than the level of questions on the actual exam. While it helped review the BOK in its entirity, I do not believe that this product is competitive to similar products produced by the Quality Council of Indiana (QCI) for reasons that do not require further elaboration at this time.
A couple other updates on CPGP exam resources have become evident since completing the review of the question bank. While it appeared that ASQ had plans to publish a relevant handbook for this certification in 2011, this product has been almost entirely removed from its website. Previously, the following description was available:
The other update is that the ASQ's Food, Drug, & Cosmetic (FDC) Division is sponsoring a column in the quarterly Journal of GXP Compliance called "ASQ CPGP Basics." This first issue of “ASQ CPGP Basics” published in October 2010 addressed the cleaning and sanitization of facilities, utilities, and equipment (https://www.gxpandjvt.com/ivtnews/templates/IVTNews.aspx?articleid=1986&zoneid=27) and the 2nd issue published in Winter 2011 addressed "Environmental Monitoring" (https://www.gxpandjvt.com/ivtnews/templates/IVTNews.aspx?articleid=2023&zoneid=27).
In providing some details of my journey in pursuing the CPGP certification and background relating to relevant resources, this discussion is posted as a possible topic of interest for the Pharma Vigilant group within the Elsmar Cove. Have you had any interest in CPGP certification? Are there any topics within the Body of Knowledge (BOK, https://asq.org/certification/pharmaceutical-gmp/bok.html) that interest you in particular or that you might be willing to comment on?
For my part, I am considering writing some blog entries related to my CPGP study efforts. I have never written a blog before, but believe that it might further the discussion, create common understanding, and lead to more focus in my current study efforts. This focus results because when you teach, you take responsibility for the learning of others and learn more yourself. Also, my recertification period expires in June 2011, and blogging may represent a possible source of publication recertification units (RUs) if relevant media reviews/articles can be documented and receive some review from peers within the Pharma Vigilant group within the Elsmar Cove.
Any feedback or suggestions relating to these proposed blogs or pursuing CPGP certification is greatly appreciated.
Having successfully completed thirteen (13) other ASQ exams on the first attempt, I still believe that becoming better prepared can lead to the realization of this goal. About a year ago, I subscribed to ASQ's "Certified Pharmaceutical GMP Professional Question Bank," but found the questions much less rigorous than the level of questions on the actual exam. While it helped review the BOK in its entirity, I do not believe that this product is competitive to similar products produced by the Quality Council of Indiana (QCI) for reasons that do not require further elaboration at this time.
A couple other updates on CPGP exam resources have become evident since completing the review of the question bank. While it appeared that ASQ had plans to publish a relevant handbook for this certification in 2011, this product has been almost entirely removed from its website. Previously, the following description was available:
"The Certified Pharmaceutical GMP Professional Handbook" (FDC Division, Item: H1386, Member Price: $73.00, List Price: $121.00) expected to be available in February 2011.
The topics in the body of knowledge (BOK) of this newest ASQ certification cover compliance with good manufacturing practices (GMPs), as regulated and guided by national and international agencies for the pharmaceutical industry. It covers finished human and veterinary drugs and biologics, ectoparasitacides, and dietary supplements (alternatively called nutraceuticals where regulated as drug products), as well as their component raw materials (including active pharmaceutical ingredients (APIs) and excipients) and packaging and labeling operations.
The other update is that the ASQ's Food, Drug, & Cosmetic (FDC) Division is sponsoring a column in the quarterly Journal of GXP Compliance called "ASQ CPGP Basics." This first issue of “ASQ CPGP Basics” published in October 2010 addressed the cleaning and sanitization of facilities, utilities, and equipment (https://www.gxpandjvt.com/ivtnews/templates/IVTNews.aspx?articleid=1986&zoneid=27) and the 2nd issue published in Winter 2011 addressed "Environmental Monitoring" (https://www.gxpandjvt.com/ivtnews/templates/IVTNews.aspx?articleid=2023&zoneid=27).
In providing some details of my journey in pursuing the CPGP certification and background relating to relevant resources, this discussion is posted as a possible topic of interest for the Pharma Vigilant group within the Elsmar Cove. Have you had any interest in CPGP certification? Are there any topics within the Body of Knowledge (BOK, https://asq.org/certification/pharmaceutical-gmp/bok.html) that interest you in particular or that you might be willing to comment on?
For my part, I am considering writing some blog entries related to my CPGP study efforts. I have never written a blog before, but believe that it might further the discussion, create common understanding, and lead to more focus in my current study efforts. This focus results because when you teach, you take responsibility for the learning of others and learn more yourself. Also, my recertification period expires in June 2011, and blogging may represent a possible source of publication recertification units (RUs) if relevant media reviews/articles can be documented and receive some review from peers within the Pharma Vigilant group within the Elsmar Cove.
Any feedback or suggestions relating to these proposed blogs or pursuing CPGP certification is greatly appreciated.