Dan Klassen

Vice President
Toscano Consulting Group
 

Dan Klassen is a Microbiologist and consultant in the field of pharmaceutical, biotechnological, and biological drug products. He has more than 35 years of experience in Regulatory Affairs CMC, Regulatory Compliance, and Quality Management Systems, specializing in aseptic processing, and works with companies on product development, regulatory strategy, regulatory submissions, training, inspection preparation, management, and remediation, and regulatory agency meetings. He has participated in the development and filing of more than 550 regulatory submissions, has more than 16,000 hours in domestic and foreign regulatory inspections, and has performed over 800 manufacturing, laboratory, and supplier cGMP audits in 17 Countries. Dan is currently Vice President for Toscano Group Consulting (TCG), after 16 years as an Independent Consultant. Prior to that, he held 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).

In 2010, on the recommendation of the Office of the Commissioner of US Health and Humans Services, the FDA Advisory Committee Oversight and Management Staff appointed Dan as Consultant to the Pharmaceutical Sciences and Clinical Pharmacology Advisory Committee.  In this Special Government Employee role, he is called upon as needed for divisional assignments and advisory committee meetings.

Dan was previously the OTC Joint Committee Chairman at NSF International and oversaw the establishment of NSF/ANSI Standard 455-4, Good Manufacturing Practices for Over the Counter (OTC) Drugs. During this time he was also a Liaison Member of the NSF International Council of Public Health Consultants.

 

Sessions: 

Plenary – Managing Data and Documentation for On-Site and Remote Inspections