Cleanroom Fundamentals - Regulation, Science, Design, Practice, Operation & Management
Course Director
Course Fee
$2650.00 Regular Registration
$2450.00 Early Bird Pricing (Register 30 Days in Advance)
Course Brochure
Future Live Stream Sessions (click to register)
Course Description
This 20 hour cleanroom fundamentals course provides comprehensive practical information on microbial contaminants and contamination control in modern cleanrooms. Extensive guidance is presented on the daily functions and monitoring necessary to maintain required cGMP microbial and particle cleanliness levels in cleanrooms.
Topics to be discussed in this cleanroom facility training include:
- Basics of microbial biology and physiology
- Cleanroom management and cleanroom design requirements
- Sources of microbial contamination in cleanrooms
- Non-viable airborne particle standards and monitoring
- Airborne and surface microbial standards and monitoring
- Origin and minimization of pyrogen contamination
- Cleaning technologies and operations
- Disinfection and sanitization materials and techniques
- Rapid microbial monitoring methods
- Training methods for proper contamination control
Emphasis is placed on attendees sharing information on their practical cleanroom knowledge and experiences with the group.
An extensive appendix providing tables, technical discussions, and scientific literature references is included with the course notes and is intended to provide background material for attendees wishing to go deeper into the subject of cleanroom microbiology.
Who Should Attend
This cleanroom facility training course is designed for professionals of the biotechnology, life sciences, medical, pharmaceutical and cosmetic industries who are interested in gaining a basic, practical understanding of cleanroom technologies. This includes professionals working in:
- Regulatory Affairs / Regulatory Operations
- Microbiology
- QA/QC
- Manufacturing
- Maintenance
- Facility Management
- Validation
FAQs
Certification Tracks
- (BDCP) Biopharmaceutical Development Certified Professional™
- (CCCP) Clinical Compliance Certified Professional™
- (CPVP) Certified Process Validation Professional™
- (GLPCP) Good Laboratory Practices (GLP) Certified Compliance Professional™
- (GMPCP) Current Good Manufacturing Practices (cGMP) Certified Professional™
- (GRACP) Global Regulatory Affairs Compliance Professional™
- (PDCP) Pharmaceutical Development Certified Professional™
Related Courses
- Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products™
- Best Practices for an Effective Cleaning Validation Program
- Molecular Biology Techniques - Applications in the Biotechnology and Pharmaceutical Industries
- Overview of the New EU Medical Devices Regulations: MDR, IVDR, CE Mark and Compliance, QMS Fundamentals
- RNA Biotechnology - An Introductory Course
Registrant Information:
Each person attending a course will be asked to set up an Attendee Profile Account during the registration process. Creating an Account helps you view your order history and manage your training programs. If you are registering for others, please set up an Account in the Attendee’s name. If you are registering more than one person, you’ll need to set up a separate account for each Attendee.