Training Course:Preparing for and Surviving an FDA InspectionSchool/Trainer:The Center for Professional Advancement
New Brunswick, United States
Course Format: Classroom | E-learning | Virtual Class | Online | On-site | Blended | Self-paced
Course Description:
'' This course provides a background and understanding of the role played by the Agency, it¡¯s administrative and enforcement powers. It takes the participant step by step through the entire inspection process and describes various types of inspections, i.e. pre-approval inspections (PAI), routine GMP inspections, bioresearch monitoring inspections, quality systems inspections techniques (QSIT) applied to device companies and system-based inspections program applied to drug companies. A detailed description of the six systems will be provided.
The course offers methodologies and techniques on:
How a firm should prepare for an FDA inspection
Ways to train employees in view of the inspection
How to ensure that required documentation is in place
How to interact with the investigator¡ªDO¡¯s and DON¡¯T¡¯s
What companies should do when the inspection ends
How to reply to 483¡¯s and warning letters
Legal implications of non-compliance
Post inspection actions
The course consists of lectures, discussions, and a practical workshop which will enable participants to work in small groups and design a company policy/procedure for handling FDA inspections.
...''
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: New Brunswick
Houses & Roommates: New Brunswick
Other training courses offered by The Center for Professional Advancement:
Excipient GMPs
Sulfonation and Sulfation
Pharmaceutical Process Development
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
cGMP Auditing - Strategies for Compliance
Patent Law
INDs, NDAs vs CTDs Global Regulations
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
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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