Klassen Consulting, LLC

Dan Klassen is a Microbiologist and independent consultant in the field of pharmaceutical, biotechnological, and biological drug products with 32 years of industry experience in Regulatory Affairs, Regulatory Compliance, and Quality Assurance. He advises companies on regulatory strategy; regulatory compliance; inspection preparation and management, regulatory authority meetings; crisis management; remediation and continuous improvement situations. Dan specializes in current Good Manufacturing Practice (cGMP), Chemistry, Manufacturing, and Controls (CMC), Regulatory Compliance, Inspection Management, and cGMP Training. He has participated in more than 550 regulatory submissions, more than 16,000 hours in domestic and foreign regulatory inspections, and has conducted over 800 manufacturing, laboratory, and supplier cGMP audits in 16 Countries.

In 2010, on the recommendation of the Office of the Commissioner, U.S. Department of Health and Human Services (HHS), the FDA Advisory Committee Oversight and Management Staff appointed him Consultant to the Pharmaceutical Sciences and Clinical Pharmacology Advisory Committee.  In this Special Government Employee (SGE) of the Executive Branch role, he is called upon as needed for divisional assignments and advisory committee meetings. 

Since 2015, Dan has played a voluntary role at NSF International as Chairman, Joint Committee Global Retailers and Manufacturers Alliance (GRMA) for establishment of NSF/ANSI Standard 455-4, Good Manufacturing Practices for Over the Counter (OTC) Drugs. The Joint Committee is charged with development of the standard for OTC drugs combining retailer and regulatory requirements into a single standard and auditing program which will help reduce audits and costs while strengthening safety, quality and trust throughout the supply chain. As a Joint Committee Chairman, he is also a Liaison Member of the NSF International Council of Public Health Consultants.

In 2018 Dan also became an Instructor for the University of California, Berkeley Regulatory Affairs Extension program which provides professional and career development opportunities for current and aspiring industry professionals. The courses Dan instructs include Principle of Regulatory Affairs; BLA/NDA/MAA submissions and Commercialization; Harmonization Across Worldwide Applications; Post Approval Activities; Principles of Quality and Compliance; Principles of Supply Chain and Manufacturing; Principles of Product and Process Development; CMC Regulatory Compliance for Pharmaceutical Products; and Drug Development Process.

Prior to his consulting role, Dan held industry positions including Principal Consultant for PAREXEL Consulting; Vice President Regulatory Affairs & Quality Assurance for AlleCure Corporation; Director Regulatory Affairs for Alpha Therapeutics; Senior Associate Regulatory Affairs & Quality Assurance for Cangene Corporation, and Manager Quality Assurance and Quality Control for Abbott Laboratories (Canada).

Dan holds a Bachelor of Science degree in Medical Microbiology from the University of Saskatchewan, Canada and has a subject certification in Diagnostic Medical Virology.  He also participated in postgraduate studies in Parenteral Medications at the University of Tennessee, College of Pharmacy. He has served in several roles in industry organizations and has presented and/or moderated at more than 30 industry conferences and workshops. He has also participated as guest lecturer for University of Southern California, School of Pharmacy, Master of Regulatory Science program; and at the Keck Graduate Institute, Claremont California.