CMC Submissions in CTD Format

The Center for Professional Advancement
Amsterdam, Netherlands

Course Format: Classroom | E-learning | Virtual Class | Online | On-site | Blended | Self-paced

Course Description:

'' This course will provide an in depth review of the chemistry, manufacturing and controls (CMC) requirements for development and ultimate submission to the FDA and European regulatory bodies in the new drug application (NDA). Emphasis will be placed on current FDA, European and ICH requirements for the filing of the quality section of the CTD for manufacturing, analytical, sterility and stability issues as they apply to the drug substance and drug product. In addition, details on supplemental applications for changes to an NDA will be presented focusing on SUPAC requirements.

This course is intended for all personnel in pharmaceutical companies especially those in:

Regulatory Affairs
Chemistry and Analytical Departments
Pre-formulation
Pharmaceutical Development
QA/QC for the CMC section of the NDA/CTD
It is recommended that you have at least one year experience in either regulatory affairs, chemistry, analytical, QA/QC or pharmacy department or pharmaceutical development to fully benefit from this course. ...''

Phone:+31/20/638.28.06

School Address:

Corporate Office
Box 7077, 44 West Ferris Street
East Brunswick, NJ USA 08816-7077
Phone: (732)238-1600
Fax: (732)238-9113
Email info@cfpa.com

Europe Office
Oudezijds Voorburgwal 316A, 1012 GM
Amsterdam, The Netherlands
Phone +31/20/638.28.06
Fax +31/20/620.21.36
Email amsterdam@cfpa.com



Jobs & Resumes: Amsterdam
Houses & Roommates: Amsterdam

Analytical Methods Validation for FDA Compliance
Excipient GMPs
Sterilization in the Pharmaceutical Industry
Good Laboratory Practices (GLP)
Non-Clinical Drug Safety Evaluation and Drug Development
Pharmaceutical Process Development
Packaging of Pharmaceuticals
Pharmaceutical cGMPs and FDA Inspections
Drug Product Stability and Shelf-Life
Pharmaceutical Water Systems
Gums and Hydrocolloids
Complaint Systems-The Essential Requirements
Choosing Sensors, Monitors and Instruments for PAT Programs
Good Distribution Practices
Lyophilization Technology
Hair Product Development
Drug Product Stability and Shelf-Life
Surfactants, Colloids and Interfaces
Crystallization Technology

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