Training Course:INDs, NDAs vs CTDs Global RegulationsSchool/Trainer:The Center for Professional Advancement
Millbrae, New Brunswick, United States
Course Format: Classroom | E-learning | Virtual Class | Online | On-site | Blended | Self-paced
Course Description:
'' The content of this course is designed to present the intricate parts of INDs, NDAs, BLAs, ANDAs, SNDAs and CTDs. These regulatory submissions for drug and biologic products will be based on the requirements of the US Code of Federal Regulations, the ICH Guidelines for global submissions and the EU Directives. Specifics of the IND, NDA, BLA, ANDA, SNDA and CTD will be detailed for safety, quality, and efficacy. Non and pre-clinical data, clinical data and CMC data to achieve product approvals globally will be enumerated for expediting new product approvals. Other subject areas include:
FDAs internal structure, policies, and procedures
GCP, GLP and GMP regulation requirements for INDs, NDAs, BLAs, ANDAs, SNDAs, CTDs and Drug Master Files
The FDA review process for new product approvals, including FDA/Industry Meetings and Liaison Acceptance of foreign data for new product approvals, EU Directives on global submissions.
...''
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: Millbrae, New Brunswick
Houses & Roommates: Millbrae, New Brunswick
Other training courses offered by The Center for Professional Advancement:
Skin Product Development
Laboratory Control Systems
Pharmaceutical cGMPs and FDA Inspections
Cosmetic Product Formulation
Regulatory Compliance for the Personal Care Products Industry
Clinical Protocols
Hair Product Development
Preparing for and Surviving an FDA Inspection
cGMP Auditing - Strategies for Compliance
Patent Law
Granulation, Tabletting and Capsule Technology
System Validation, GAMP Harmonization and P.A.T
Lyophilization Technology
Pharmaceutical Quality Assurance and Control
Critical Process Cleaning and Cleaning Validation
cGMP for Pharmaceutical Production Supervisors
Good Laboratory Practices (GLP)
Emulsion-Suspension
Aerosol Technology
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