ISO 22716 GMPs for Cosmetic and Personal Care Professionals

Dates

Times

2 days

Location

Virtual Learning

Availability

About This Course

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 This course has been updated with information from the U.S. FDA's draft guidance for cosmetics manufacturing, U.S. FDA's GMP Inspection Checklist for Cosmetics, and general requirements from the Modernization of Cosmetic Regulations Act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 Learners will understand the globally recognized ISO 22716 standards and the U.S. FDA’s draft guidance for cosmetics manufacturing.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

Who Should Attend?

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

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.

Additional Recommended Courses

21 CFR 111 Dietary Supplement GMP Overview Intro

This course provides an overview of 21 cCFR 111, the Dietary Supplement CGMPs. This abridged course includes an introduction to current good manufacturing practices (cGMPs), required product quality elements, documentation, investigations and a brief overview of the relevant subparts. We will also review the proper way to execute GMP records, detail the personal hygiene requirements, examine the meaning of master and batch records for control of production, labeling and packaging, clarify the requirements of quality and describe the purpose of GMP rules, regulations and FDA enforcement.
o Personnel
o Buildings and Facilities
o Equipment
o Facility Records
o Production and Process Control
o Holding and Distribution
o Batch Records
o Packaging and Labeling
o Quality Control and Quality Assurance
o Laboratory Operations
o Product Complaints
· The role of the FDA and their authority
· The roles and responsibilities of the Quality Unit
As a part of maintaining compliance to 21 CFR 111, dietary supplement personnel must have GMP training on a regular basis.
Dates: December 5, 2024 & December 6, 2024
Time: 1:00 P.M to 5:00 P.M Eastern Time

Cost: $900.00
Course Prerequisites: None

*Register 3 or more attendees from the same company and receive a 10% discount off each registration*

Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.

Course log in details will be sent in a separate email. Certificate of attendance will be issued upon completion of the course. Completion of the course means being in attendance 95% of the log in time.

Virtual Classroom Training
Vendor Qualification and Audit Training for Dietary Supplements

Vendor Qualification and Audit Training


Unless you intend to test every shipment of every component for every specification, you must qualify your vendors. But FDA does not provide much guidance on how to qualify vendors. This class is designed for to give people who want to improve quality in their facility and who already have a basic understanding of the Dietary Supplement GMPs, the knowledge and skills necessary to qualify suppliers. Since the evaluation of all types of suppliers often involves auditing, this course will incorporate a fresh look at the process of auditing and the skills and techniques necessary to get the most from these activities. The auditing skills and techniques learned in this course are independent of the type of auditing or the standard being audited. These skills and techniques will be useful when conducting internal audits as well as performing audits of suppliers

Day 1: June 20, 2024 1:00pm.-5:00pm Eastern Time
Day 2: June 21, 2024 1:00pm-5:00pm Eastern Time

Cost: $900.00

Completion of the course means being in attendance 95% of the log in time. Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification. Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification.

Virtual Classroom Training
Internal Auditing Training for Dietary Supplement

This course is 8-Hours. This dietary supplement internal auditing course will help you understand the fundamentals of auditing and how to conduct an internal audit focused on cGMP and other FDA requirements. The training incorporates internal audit best practices, regulatory requirements and information on turning internal audit findings into useful information. Requirements for 21 CFR 111, supplier programs and FSMA are incorporated into the content.
You’ll learn how to prepare, perform, report and close an audit and discuss the importance of using CAPA systems as a follow-up to your internal audit findings.

Part 1 - October 17, 2024 1:00pm.-5:00pm Eastern Time
Part 2 - October 18, 2024 1:00pm-5:00pm Eastern Time

Cost: $600.00
*Register 3 or more attendees from the same company under the "General Registration" type, and receive a 10% discount off each registration*

Attending NSF training sessions does not provide an advantage, nor is it linked in any way to the granting of certification. Course log in details will be sent in a separate email. Certificate of attendance will be issued upon completion of the course. Completion of the course means being in attendance 95% of the log in time.

Virtual Classroom Training