Wednesday, December 18, 2019

FDA cGMP QSR GMP Online Training Courses by SkillsPlus International Inc.

FDA cGMP QSR GMP Online Training Courses by SkillsPlus International Inc.
FDA cGMP QSR GMP Online Training Courses by SkillsPlus International Inc.


FDA cGMP QSR GMP Online Training

Benefits

  • Use in the classroom as a training video
  • Standardize content delivery
  • Reduce training expense with our online learning pricing
  • Use in one-on-one training environments
  • Make these classes a part of corrective and preventive actions 

Details

  • $50 per individual course 
  • Once a course is purchased, you'll be able to view the course one-time (within 48 hours from the time of purchase). 
  • Call us about Annual Global License pricing.

  • Interested in a course? Give us a call:  (415) 948-5220

Courses Available

  • 21 CFR 211: Pure, Safe, and Effective  - This program reviews 21 CFR 211 with the reminder that all these rules help us produce a product that is pure, safe and effective. This program is a must for new employee orientation training at all levels of the organization.
  • Documentation Practices  - This program provides a most interesting review of proper documentation practices for both paper-based and electronic record environments. 
  • Equipment and CGMPs - This topic discusses the requirements of 21 CFR211 Subpart D - Equipment, specifically the design and construction requirements for equipment including lubrication and coolants. The class addresses cleaning and maintenance requirements including automatic and electronic equipment. The class also covers the requirements for equipment identification, and required documentation.

Courses Coming Soon!

  • Buildings and Facilities (Coming 2019) - This topic provides a review of the requirements of Building and Facilities issues well beyond Subpart C, Buildings and Facilities.  This program, uses many video segments from actual plant operations to review the essential elements of this Subpart.
  • Surviving an FDA Inspection  (Coming 2019) - Learn what to expect, how to plan for an inspection, and how to behave. This program has demonstrations of interviews and different response strategies. Some are intended to be humorous, while some are common mistakes made when interacting with the FDA. Use this program to plan for your next inspection.
  • Understanding Validation  (Coming 2019) - Delve into the intricate rules and practices of validation. This course is based on guidance documents on validation. The concepts of validation are explained in simple language. This is a great introduction to validation as well as preparation for the plant's next major validation initiative.
  • Contamination Control  (Coming 2019) - This topic discusses the sources of contamination and methods to prevent contaminating products. This is a great session for new employees needing to learn about the risks and proper behaviors to controlling contamination. Use this program as part of a corrective or preventive action as a result of contamination control breaches.
  • Materials and CGMP  (Coming 2019) -  This topic traces the CGMP requirements from supplier qualification through to manufacturing and packaging. A solid review of 21 CFR 211 Subpart E, Control of Components, Drug Product Containers and Closures.
  • Organization and Personnel  (Coming 2019) -  This topic summarizes the essential elements of 21CFR211 Subpart B, Organization and Personnel. This is a great orientation to this subpart for new employees or serves as a quick refresher.
  • Production and Process Control  (Coming 2019) -  This topic provides a review of the requirements of 21 CFR 211 Subpart F, Production and Process Controls.  This program, uses many video segments from actual plant operations to review the essential elements of this Subpart.
  • Implementing A Successful Change Control Program (Coming 2019) - This program reviews the requirements of change control and components of a successful change control program.

From SkillsPlus International Inc.

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