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QA/RA Consulting, Auditing & Training

Introduction to Cosmetics Manufacturing Regulations and ISO 22716:2007 GMP

Stay ahead in the cosmetics industry by diving deep into current US requirements and ISO 22716:2007 GMP guidance with our comprehensive course.

Designed for industry professionals seeking to bridge the gap between pre-MoCRA regulations and the new era of cosmetic oversight, this course offers real-world exercises to help you assess the impact of these changes on your existing management systems.

Develop a strategic roadmap for compliance and ensure that your operations meet the latest regulatory standards.

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Brief Overview of This Cosmetics Regulatory Training Class

SkillsLab Class ?

Class Content

In-Depth

Class Duration

2 Days

Teaching Format

Live, Instructor-Led

Delivery Options

Private Team Training Only*

Certification of Completion

Yes

Continuing Education Units (CEUs)

1.6

* This class is only offered privately to groups of six or more. We can conduct this class virtually or at your facility.

Upcoming Classes

Upcoming Cosmetics Regulatory Overview Training Classes

SkillsLab $3300

SkillsLab $3300

There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

What We Cover in This Cosmetics Regulatory Overview Training Class

Participants of this course will be equipped to navigate the evolving cosmetics regulatory landscape by understanding current US requirements and ISO 22716:2007 GMP guidance. They will be able to assess the impact of regulatory changes on their existing management systems and develop strategic roadmaps for compliance. Through real-world exercises, participants will gain practical skills to ensure that their operations meet the latest regulatory standards and maintain compliance in the cosmetics industry.

Course Overview

SkillsLab Class

MoCRA Regulatory Overview

What is MoCRA?
What's new? Obligations for manufacturers, packers, and distributors
Resources and impact of the requirements
Effects of registration suspension

Exercise! Identify Potential Action Points

MoCRA Facility and Product Registration Requirements

Facility and product review and registration
Supply chain review
Determine facility registration

Exercise! Assess the Impact of Facility and Product Registration Requirements on Your Processes and Your Supply Chain

MoCRA Safety Substantiation and Adverse Event Reporting

Safety substantiation requirements
Responsible person checklist
Adverse event reporting requirements

Exercise! Assess the Impact on Your Organization’s Processes

MoCRA Production Impact

Good Manufacturing Practices
Other provisions: Asbestos in talc-containing products, PFAS

Exercise! Assess GMP Impact on Your Organization’s Processes

Exercise! Assess the Labeling and Other Provisions Impact on Your Organization’s Processes

MoCRA Enforcement Authority

Preemption
Recalls
Inspections
Suspension
Next steps action planning

Exercise! Enforcement Activities

Overview of ISO 22716:2007 and US FDA GMPs

What are GMPs? Why GMPs?
How GMPs support the quality management system
Introduction to ISO 22716 and US FDA GMP

Exercise! Consider Your Gaps

Resource Management

Scope and definitions
Personnel
Premises
Equipment
Raw materials and packaging materials

Exercise! Identify Key Action Points for Personnel

Exercise! Assess Equipment and Raw Materials

Product Realization

Production of product and packaging
Finished products
Quality control laboratory
Treatment of product that is out of specification
Wastes

Exercise! Assess the Impact on Production Processes, Finished Product Processes

Exercise! Assess Quality Control Laboratory Processes

Exercise! Assess the Impact on Waste Handling Processes

Measurement, Analysis, and Improvement

Subcontracting
Deviations
Complaints and recalls
Change control
Internal audits
Documentation
Action planning and next steps

Exercise! Assess the Impact on Measurement, Analysis, and Improvement Processes

What You Will Learn

At the conclusion of this training class, you will be able to

SkillsLab

Determine and map the impact of MoCRA on your existing cosmetic manufacturing processes, creating an action plan for compliance regarding registration, safety substantiation, adverse events, labeling, GMP, testing, recalls

Gain awareness of MoCRA regulatory enforcement risks, and FDA authority regarding inspection, recall, and suspension

Review US FDA regulatory requirements for cosmetics and discuss compliance with the US FDA timeline for MoCRA implementation

Based on discussions about the differences between ISO 22716:2007 guidance and US FDA Guidance for Industry Cosmetics GMP 2013, create an ISO 22716 impact map to plan actions, assign resources needed, and determine timeframes for implementation

Who Should Attend

This course is recommended for cross-functional team members in cosmetics manufacturing, distribution, or packing.

Quality managers
Regulatory professionals
Operations managers
Internal auditors

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