Drug Specifications for APIs and Drug Products

The Center for Professional Advancement
East Brunswick, New Jersey, United States

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

Course Description:

'' The course will present a review of the activities that will occur in the process of setting specifications for APIs made by synthesis or conventional fermentation. Critical specification issues for drug substances and drug products will be reviewed, specifically focusing on the interactions and dialogue necessary between analytical and pharmaceutical/ chemical groups during the development of specifications. Using practical examples, the importance of understanding ¡°real-life¡± constraints and regulatory requirements will be highlighted across a wide variety of drug product formulations. Strategies for Out-Of-Specification (OOS) findings will be discussed. The course will review the latest activities of ICH with respect to specifications for drug substances and drug products. You will benefit in your job by applying facts learned in this course. Increases in productivity will result. An open and interactive environment is encouraged throughout the course.
...''

Phone:(732)238-1600

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: East Brunswick
Houses & Roommates: East Brunswick

Analytical Methods Validation for FDA Compliance
Drug Product Stability and Shelf-Life
Microbiological Control and Validation
Process Validation for the Pharmaceutical and Medical Device Industry
Non-Clinical Drug Safety Evaluation and Drug Development
ADME: Absorption, Distribution, Metabolism and Elimination
Root Cause Investigation for CAPA
Complaint Procedures for Medical Devices
Early Stage Clinical Studies for Drugs and Devices
Drug Delivery Technologies
The Quality System
Good Clinical Practices (GCP)
Generic Drug Approvals
Generic Drug Approvals
Good Clinical Practices (GCP)
Quality Audits
Packaging of Pharmaceuticals
Preparation, Packaging and Labeling of Clinical Trial Materials
Tablet Production for Operators and Supervisors

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