By SkillsPlus International Inc.
If you're interested in a course, just give us a call: (415) 948-5220.
Welcome to SkillsPlus International Inc.
This page provides information about our online training courses.
- $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
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.
Practices - This program provides a most interesting review
of proper documentation practices for both paper-based and electronic
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.
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
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.
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.
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
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.
and Personnel (Coming 2019)
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.
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.
in the classroom as a training video
training expense with our online learning pricing
in one-on-one training environments
these classes a part of corrective and preventive actions
a prompt reply to requests and questions: (415) 948-5220 |
1991-2019 SkillsPlus International Inc.