CGMP Training: A New Generation - SkillsPlus International Inc.

Course Descriptions

Select from these to create a custom course for your CGMP Training: A New Generation.

Image of piles of notes with the text, "We make the regulations easy to understand." — SkillsPlus International Inc. makes the regulations easy to understand

21 CFR 211: Pure, Safe and Effective – Overview of 21 CFR 211
Your Personal Responsibilities: Organization and Personnel – Detailed review of 21 CFR 211 – Subpart B
Foundation to Facility – Detailed review of 21 CFR 211 – Subpart C
Maintaining Compliant Equipment Practices – Detailed review of 21 CFR 211 – Subpart D
Supplier to Plant – Detailed review of 21 CFR 211 – Subpart E
Plan To Production – Detailed review of 21 CFR 211 – Subpart F
Plant To Patient – Detailed review of 21 CFR 211 – Subpart G, H, & K
Laboratory To Release – Detailed review of 21 CFR 211 – Subpart I
Proper Documentation Practices – Detailed review of 21 CFR 211 – Subpart J
21 CFR Part 820: Overview of QSR – Detailed review of 21 CFR 820 – Subpart A-O

Course Descriptions For CGMP Training: A New Generation Series

Image of the hierarchy of compliance from CGMPs: The New Generation Series. — Hierarchy of compliance from CGMPs: The New Generation Series.

21 CFR 211: Pure, Safe and Effective – Overview of 21 CFR 211
This course provides a solid basic understanding of the CGMP Regulations for Pharmaceutical Manufacturers and Packagers. This is a great starting course for all all employees from pharmaceutical, biologic and bio-tech drug manufacturers.

Email us or give us a call to discuss your training needs. Simply contact us for more information about CGMP Training: A New Generation!

All of the courses below can be customized by selecting or excluding specific topics:

Slide image from "Your Personal Responsibilities" — Your Personal Responsibilities – Handwashing

Your Personal Responsibilities: Organization and Personnel – 21 CFR 211 – Subpart B
This course provides a detailed explanation into: the role of the Quality Unit; what is really meant by “training, education, and experience”; the application of the adequate staffing requirements; source of contamination; the history of handwashing; hand washing methods in a world with Covid-19; basic gowning; and reporting of illness and lesions. This is a great starting course for all all employees from pharmaceutical, biologic and bio-tech drug manufacturers. Consider this topic for handwashing refresher training also.

Email us or give us a call to discuss your training needs. Simply contact us for more information about CGMP Training: A New Generation!

Slide image from "Foundation to Facility" — Foundation to Facility – Shipping & Receiving

Foundation to Facility – 21 CFR 211 – Subpart C
This course is offered in two levels. A basic level for all plant employees and an advanced level for employees responsible for the design and construction or renovation of production and laboratory facilities. This complete course provides a detailed discussion of: the design and use of space; the requirements for adequate construction; the uses of defined spaces; a comprehensive survey of plant utilities; a concise discussion of air filtration; an in-depth discussion of temperature and humidity; an explanation of air classifications; the requirements for plumbing systems, the standards for water storage; a discussion of steam and chilled water; pest control requirements with insights from pest control technicians; facility cleaning and maintenance requirements, and a review of environmental monitoring requirements. This is a great starting course for all all employees from pharmaceutical, biologic and bio-tech drug manufacturers. It is also a great orientation for engineers new to pharmaceuticals and specifically the CGMP. It is also a good review for engineers as an annual refresher or prior to launching new facility based projects.