Training Course:Analytical Methods Validation for FDA ComplianceSchool/Trainer: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:
'' One of the most critical factors in developing and marketing pharmaceutical drug substances and drug products today is ensuring that the analytical methods used for analysis can generate valid data upon which business and regulatory decisions can be made. FDA, ICH and USP have each recognized the importance of this to the drug development process and have separately expanded method validation requirements in recent years. However, with only limited guidance, industry has been left to interpret how to adequately comply with the regulations.
Whether involved in method development, method validation, method optimization or method transfer, this course will provide a broad understanding and ¡°hands-on¡± knowledge of the method validation process and the difficulties encountered in validating methods to comply with today¡¯s upgraded FDA CDER requirements. Lectures will include not only theoretical basis and practical applications, but actual validation examples of HPLC, GC, UV/Vis, AA, and titration methods for small organic molecules. Some of the more common mathematical and statistical treatments of validation data will also be discussed. Because of the tremendous effort that can be expended in conducting validation studies, efficiency of experimental design and documentation will be stressed throughout the discussions.
Although the general principles in this course may be applied to methods for testing biological molecules and medical devices, the focus of this course is on the validation of methods for the analysis of small molecules.
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Please go to the school's official website for training price and schedule:
http://www.cfpa.com
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
Other training courses offered by The Center for Professional Advancement:
Food Extrusion Technology
Complaint Procedures for Medical Devices
Microencapsulation and Particle Coating
Nanotechnology
ISO 13485, ISO 9001 and QSR Regulations for Medical Device Companies
Project Management
Risk Analysis & Human Factors Engineering
Gums and Hydrocolloids
Microencapsulation and Particle Coating
Documentation Management and Control
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
Notice: The course description on this page was captured from the Internet as historical reference or submitted by visitors. It was archived statically and not updated from day to day.
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