Training Course:System Validation, GAMP Harmonization and P.A.TSchool/Trainer:The Center for Professional Advancement
Boca Raton, FL, United States
Course Format: Classroom | E-learning | Virtual Class | Online | On-site | Blended | Self-paced
Course Description:
'' This course is designed to provide the basics of computer system validation. Utilizing lectures, discussions, hands on exercises, the class will address the rules, tools and techniques needed to develop, manage, and conduct a validation process and project. The program focuses on the best validation practices utilizing, Risk assessment, PAT, GAMP 4 and more. Included in this comprehensive course is:
Validation testing, The Validation Plan, SOPs
System Life Cycle, Hazard Assessment
Validation Requirements of Predicate Rules including: cGMPs, GLPs, QSRs and GCPs
ERES 21 CFR Part11, Electronic Submissions
Disaster Planning and Business continuation, IQ, OQ, PQ
System Security, Training Requirements, Traceability
Source Code Vendor Review
COTs and Shrink Wrapped Systems
GAMP 4 and PAT
Sarbanes Oxley
FDA Guidance for Industry-Computerized Systems Used in Clinical Trials
The course workbook is designed to support you in class and to be a detailed and complete validation reference guide. ...''
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: Boca Raton
Houses & Roommates: Boca Raton
Other training courses offered by The Center for Professional Advancement:
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
INDs, NDAs vs CTDs Global Regulations
Granulation, Tabletting and Capsule Technology
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
Process Analytical Technology
Color Additives and Their Use in Decorative Cosmetics
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