ISO 22716 GMPs for Cosmetic and Personal Care Professionals

The ISO 22716 GMP cosmetics training will show you how to identify regulatory non-compliances before they become an issue, minimizing risk while adding measurable value to the manufacturing process. This course has been updated with information from the U.S. FDA's draft guidance for cosmetics manufacturing, U.S. FDA's GMP Inspection Checklist for Cosmetics, and general requirements from the Modernization of Cosmetic Regulations Act (MoCRA) enacted in December 2022. Learners will understand the globally recognized ISO 22716 standards and the U.S. FDA’s draft guidance for cosmetics manufacturing.

At the end of the course, you will understand:

• Understand the role that Quality plays in ISO 22716 and Cosmetic GMPs
• Provide an in-depth understanding and knowledge base of the essential principles and requirements of ISO 22716, Good Manufacturing Practices (GMPs)
• Understand how the U.S. FDA Guidance aligns with ISO 22716
• Explain the special requirements needed to build a quality management system (QMS) in compliance to the ISO 22716 standard and FDA Guidance
• Understand the scope of ISO 22716
• Recognize the effective rules and organizational guidelines focused on human, technical and administrative factors affecting product quality
• Understand how the newly enacted Modernization of Cosmetic Regulations Act impacts cGMP and related requirements for cosmetic manufacturing

This course is geared to those individuals involved in the cosmetics industry including:

• Marketing
• Quality Control/Assurance
• Packaging
• Manufacturing
• Laboratory Operations
• Suppliers and Distributors
• Auditing
• Regulatory Affairs
• Sales
• Retailers
• Product Development
• Brand Holders

Course instructors will be selected from the following:

Heidi Horn - Heidi Horn is a Life Science Regulatory professional with 20+ years of experience leading regulatory teams responsible for drug, dietary supplement, and cosmetic product compliance. Starting her career as a Quality Control Technician, Heidi became interested in gaining a deeper understanding of the regulatory requirements impacting healthcare products and was quickly promoted into a Regulatory Affairs role.

During Heidi’s tenure in Regulatory Affairs, she and her teams were responsible for reviewing product safety and efficacy, identifying a product’s legal basis to market, developing and ensuring labeling content accuracy, substantiating label claims, completing drug listing and site registrations, as well as conducting merger and acquisition (M&A) due diligence.

As a trusted and well-respected leader, Heidi was often relied on to represent the company’s interests at Food & Drug Administration (FDA) and Consumer Product Safety Commission (CPSC) public meetings, conferences, and trade association meetings. For several years, Heidi was the Co-chair of the Council for Responsible Nutrition Regulatory Affairs Committee. As a former educator, she is passionate about coaching, developing, and growing the experience of others.

Heidi worked 30+ years for a global Life Science Fortune 500 company, with 20+ years of Regulatory leadership experience and 10+ years leading the Risk Management function. She holds a Bachelor of Science degree in Biology from Alma College, a Master of Arts degree in Teaching Biology from Central Michigan University, and a Master of Business Administration from Grand Valley State University.

Nicole Leitz - Nicole Leitz has more than 20 years of experience in the 21 CFR regulated industries. She has written and presented numerous training sessions on quality system elements and best cGMP practices to corporate clients and at national conventions. Nicole is also an experienced remediation consultant. She has advised, and written documentation, such as SOPs and WIs and completed root cause investigations, CAPAs and complaints for corporate clients.

Nicole has a Master of Science degree in organic chemistry from Bucknell University and a Bachelor of Science in ACS chemistry from Hope College.