"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
Tammy M. Pelnik
Tammy Pelnik is an industry expert, a quality systems consultant and President of The St. Vrain Group, Inc., a management and technology consulting firm. Ms. Pelnik is noted for her subject matter knowledge, expertise in presenting engaging courses, and her frank, direct approach to addressing attendee questions throughout each class.
She works with client firms to establish cost-effective quality systems and innovative process improvement plans. She provides staff assessment/enhancement planning and “crisis” project management services for product development efforts. Ms. Pelnik has significant experience in developing integrated Quality Systems and development processes for combination products. Prior to joining The St. Vrain Group, Inc., Ms. Pelnik was a Senior QA Manager with an international Class III device firm.
Ms. Pelnik is an ASQ Certified Quality Manager and Certified Quality Engineer, IRCA QMS Principal Auditor and holds a MS degree in computer science. Ms. Pelnik is on AAMI’s Board of Directors and has been a member of the AAMI faculty for many years. She has served on the Biomedical Instrumentation and Technology Editorial Board, the Regulatory Affairs Professionals’ Rocky Mountain Chapter steering committee and the ASQ Boulder Section’s leadership team. She has published articles in Regulatory Affairs Focus, Medical Device and Diagnostic Industry, Software Quality Journal, Biomedical Instrumentation & Technology and numerous conference proceedings.