Kenneth H. Muhvich, Ph.D. is a globally-recognized consultant specializing in Microbiology and Regulatory Compliance. Based in Charlotte, NC, USA, Ken lives within a half hour drive from the Charlotte Douglas International Airport, the 6th busiest airport in the world.
Specialties:
- Investigations - guiding pharmaceutical firms needing investigations into sterility assurance failures
- Environmental Monitoring - assistance in identifying negative trends in facility EM data and in performing EMPQ.
- Filamentous Mold Investigations & Mitigation Activities
- Audits of sterile manufacturing facilities and microbiology labs in preparation for FDA Mock Inspections
- Assistance in developing 483 Response Strategies
Affiliations: Jeff Yuen and Associates