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Introduction to 21 CFR 111 cGMP Requirements (PCER1322-1)

COURSE CUSTOMIZATION OPTION

After conducting a learning needs assessment, we can customize this course so participants can relate to their organization's specific operations and resources. Participants may be eligible to earn Continuing Education Units (CEUs). Contact us to learn more about how we can create a similar customized course for you and your team!

ABOUT THE COURSE/ UNIT

  • Title - Introduction to 21 CFR 111 cGMP Requirements

  • Event Code - PCER1322-1

  • Learner Level – *Level 2 - Introduction

  • Delivery – Blended (Remote & Online)

  • Duration - **Minimum six (6) days of participant contact time.

  • Offering - Customized Only. (Closed to the public)

  • Cost/ Fees – Per Client Service Agreement.

  • NOTE:

*Learner Level is defined by our Continuing Education & Training (CET) Team.

**Contact time and online access duration to be confirmed with client and communicated by the instructor to the participants.

 

OVERVIEW

The purpose of this unit is to improve the participants’ understanding of the requirements of Current Good Manufacturing Practices (cGMP). The lessons will be taught within the context of Dietary Supplement manufacturing.

 

EVENT OBJECTIVES

By the end of this event, participants should be able to:

  1. Describe in basic terms the risks and reasons for controls related to cGMP for Dietary Supplements (21 CFR 111 Sub-parts B to P).

  2. Identify at least three (3) activities at a manufacturing facility that can be associated with the requirements described in Sub-parts B to P of 21 CFR 111.

 

KEY TOPICS

  • The FDA’s definition of Preventive Controls.

  • Risks and related controls associated with 21 CFR 111 Sub-parts B- P.

  • Overview of the requirements of 21 CFR 111 Sub-parts B- P.

  • Typical activities associated with 21 CFR 111 Sub-parts B- P.

 

INTENDED AUDIENCE

This unit was designed for the following audience:

  • Individuals seeking to improve their ability to develop, maintain and improve a cGMP program for Dietary Supplement manufacturing.

  • Individuals interested in understanding FDA and other requirements for a cGMP program for Dietary Supplement manufacturing.

  • Supervisory/ Management level responsibility and authority.

  • Plant Manager, Production Manager, Quality Manager, Quality Engineer

 

WHY ATTEND?

  • By attending this event, you can learn more about the FDA cGMP requirements for Dietary Supplement manufacturing.

  • You will hear from a Food Safety Specialist regarding 21 CFR 111.

  • This is an opportunity to better understand the purpose of the food safety-related activities at your facility.

  • Do you Supervise a Team? Be better prepared when communicating with them regarding your internal programs by learning more about the requirements of cGMP as outlined in 21 CFR 111.

 

PREREQUISITES/ PRIOR KNOWLEDGE

Individuals participating in this unit should have the following level of knowledge and skill:

  • Awareness of the purpose of one or more of the following:

    • Good Hygiene Principles

    • Prerequisite Programs (PRP)

    • Good Manufacturing Practices (GMP)

    • Preventive Controls

  • Familiarity with the typical activities in a manufacturing environment is preferred.

 

WHAT TO EXPECT

  • Links to information from regulatory agencies/ standards owners.

  • Live, instructor-led, remote session.

  • Online access to participant materials (if required).

  • Feedback on learning progress from the instructor and via results of online activities.

  • Support for technical or other questions.

 

SUCCESSFUL COMPLETION CRITERIA

To successfully complete this unit, participants are required to:

  • Attend all instructor-led sessions and complete any required group or online activities.

  • Achieve a passing score of 70%, or higher on Final Test. Note: Two (2) attempts allowed.

  • Comply with Onazry policies.

  • Complete activities before the unit expires (Instructor will provide dates).

 

COMPLETION ACKNOWLEDGEMENT

  • Attendance certificate.

 

PRESENTATION DEVELOPER & PRESENTER/ TRAINER

  • Content developed by our Continuing Education & Training (CET) Team.

  • Presenters are experienced, trained, qualified, subject matter experts.

  • Michelle Ryan is the Lead Developer and Trainer for this course. She is also the co-owner and COO at Onazry LLC.

 

EVENT SCHEDULE

  • Dates TBD

  • Dates for instructor-led sessions will be confirmed by the instructor.

 

ACCESS TO ONLINE PORTAL

Online Account Set-Up

  • Each participant will be provided with unique user information which is to be used to access the course/ unit online.

  • Participants are required to provide an email address.

  • Accounts expire upon completion of the established duration for the course. After the course duration has passed, if you have not successfully completed the course, you will be assigned an “incomplete” status.

  • A computer will be required.

  • Reliable internet connection will improve your experience.

 

Online Account Access (Talent LMS)

Go here to access the log-in page to the Learning Management System.

 

SUPPORT – CONTACT US

  • Explore our website for more about our people, policies and courses: https://onazry.com

  • If you have questions or are experiencing technical issues before, during or after the event, please contact us at support@onazry.com .

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