Training Course:ICH Q10: Pharmaceutical Quality SystemSchool/Trainer:The Center for Professional Advancement
New Brunswick, New Jersey, United States
Course Format: Classroom | E-learning | Virtual Class | Online | On-site | Blended | Self-paced
Course Description:
'' The draft of ICH Q10 is the latest document that aims to define the requirements for a quality system for pharmaceutical operations. It discusses how the function of the system should evolve during pre-market operations, what its function is when a drug is marketed and how opportunities for product improvement should be identified and implemented throughout the product life cycle. The main element discussed in Q10 is what management, especially senior management, should be responsible for in assuring an effective Quality System. Other important elements receiving an emphasis in Q10 are the Quality System components such as change control, deviation control, CAPA, root cause determination, input/process/output monitoring, product reviews and documentation.
This course analyzes the content of Q10 and compares it with previous standards including the FDA Guidance on Quality Systems and ISO 9000. It analyzes its relationship with Q8 (Product Development) and Q9 (Risk Management) and the FDA Guidance on their Six-Systems Inspection Program and discusses the quality systems to which Q10 refers with particular reference as to how such systems can be effectively managed & integrated in accordance with Q10.
Throughout the course interactive discussion on this new, most important and far reaching Guideline will be encouraged.
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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: New Brunswick
Houses & Roommates: New Brunswick
Other training courses offered by The Center for Professional Advancement:
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
Pharmaceutical Technology Transfer
ICH-Q7A
IQ, OQ, PQ
Current Good Manufacturing Practice (cGMP) for Purchasing
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
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