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.