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Joseph J. Stojak
 

joseph@cGxP.com

http://www.cGxP.com

25 Harbor Drive., Suite101

Vernon Hills, IL,60061

Practical Compliance Solutions

 (847) 549- 0626 ext.222

 

Joseph J. Stojak had a 38-year career within the federal government and all aspects of the FDA.  Mr. Stojak is a former FDA National Expert.  As a former National Expert, Mr. Stojak is recognized as a valuable resource person providing advice and direction to many of the FDA Field  inspectors. He recently retired from FDA's Office of Regulatory Affairs (ORA), Division of Emergencies and Investigational Operations (DEIO).  For more than 22 years he performed numerous inspections at drug and device manufacturers throughout the United States, Europe, the Middle East, Asia, and Australia. 

Mr. Stojak's FDA experience with both drug GMPs and Device GMP (QS requirements) were primarily obtained during the performance of many ANDA, NDA, PAI, PMA, 510(k) and other special assignment inspections at firms located nationally and abroad.  His specialized experience with sterile drug device products and sterilization processes qualified him as lead FDA instructor for FDA's "Industrial Sterilization of Drugs and Device Products" courses.  Mr. Stojak was also an instructor in FDA's "Process Validation", "Basic Drug", "Basic Device" and "Orientation to Foreign Inspection" courses presented to FDA personnel.

In addition to Mr. Stojak's inspection and training experience, he was a FDA Certified Performance Auditor conducting audits of FDA Device Investigators and Team Biologics Investigators.  He received Certification from Accadema Qualitas and completed both a ISO 9000 Documentation course and the ISO 10011 Auditor Training Course.

Some of Mr. Stojak's activities outside of FDA included active participation in several committees of the Association for the Advancement of Medical Instrumentation (AAMI) where he worked on the sterilization standards for health care products.  He was a co- chair of the working group for " Process and Product Equivalency for Ethylene Oxide Sterilization" and an active member of the AAMI working groups for "Aseptic Processing" and "Process and Process Equivalency for Radiation Sterilization."  In addition, he has provided training and formal presentations to individual manufacturing firms and industry group meetings such as: PDA, HIMA, ISPE, DIA, ASQ, and others.

Current activities include assessment audits of sterile drug manufacturers, biotech facilities, and medical device manufacturers in the US, Europe, and South America.  The work with clients includes the development of Quality Assurance, Manufacturing, and Regulatory strategies for compliance with FDA and worldwide regulations.

 

 

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