Pharmaceutical Quality Assurance and Control

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 provides an understanding of the principles and practice of pharmaceutical quality assurance and control and of specific topics which have become important because of regulatory interest or recent technological achievements. Throughout the course an emphasis is placed upon quality as viewed on a cost/benefit basis as well as a cGMP basis.

The first day provides an understanding of the basic principles and practice of the QA and QC functions, covering their role during product design, production and revision, with the role in production being dealt with in particular detail. The second, third and fourth days consist of reviews, first of broad current quality issues including FDA activities, and then the QA/QC aspects of a number of specific issues including: handling of laboratory controls, validation (equipment, processes, computers, cleaning and test methods), label and labeling, water systems, change control, electronic records and signatures, deviations and discrepancies, (including OOSs), FDA inspections, internal and supplier audits, vendor and contract supplier qualification, annual product reviews, and training. A general question and answer session is also provided. The fifth day is devoted to the QA/QC aspects of stability program operation and also to documentation. The course includes hands-on workshops as well as lectures.
...''

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

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
System Validation, GAMP Harmonization and P.A.T
Lyophilization Technology
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
Industrial Drying of Heat Sensitive Materials
Powder Mixing Technology

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