Cosmetic Good Manufacturing Practices: Understanding ISO 22716
Discussion and Working Groups:
A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice. Additionally, discussion periods will provide delegates with plenty of time to obtain answers to their specific questions and concerns.
About This Course:
This course is intended to provide manufacturers of cosmetics, as defined in the FD&C Act, Sec. 201(i) an understanding of, and the necessary information for implementation of ISO 22716: Good Manufacturing Practices of Cosmetics in their manufacturing, distribution, warehousing, and labeling operations. This course provides an in-depth review of the globally recognized ISO standard, along with information on FDA’s recently updated (June 2013) Draft Guidance for Industry: Cosmetic Good Manufacturing Practices.
About NSF International's Cosmetic and Personal Care Program:
The Cosmetic and Personal Care program provides manufacturers of these product categories GMP auditing and facility certification, training and education, consulting, contaminant testing, label claim verification testing, R&D, and regulatory guidance for the cosmetic, personal care, and consumer product industries throughout the entire product lifecycle. NSF International developed the only American National Standard for Organic Personal Care (NSF/ANSI 305) and evaluates and certifies supplements against this standard. NSF's Cosmetic and Personal Care Program operates globally throughout North America, Europe, the Middle East, Africa, Asia and Latin America. NSF International offers ISO 22716 registrations for cosmetic manufacturers delivered through NSF International Strategic Registrations, Ltd. (NSF-ISR).
Benefits/What You Will Learn:
Comprehensive review of ISO 22716, Good Manufacturing Practices for Cosmetics, providing a thorough understanding of each section relevant to a company’s operations
Who Should Attend:
Jan L. Warner BS, MS, MBA BIO
Jan Warner is an accomplished, broad-based regulatory, quality and compliance professional with over 25 years of experience in the following products and industries: pharmaceutical, medical device, OTC and personal care, homeopathic drugs, dietary supplements and cosmetics. He has held numerous upper management responsibilities in quality assurance, compliance and quality control at companies such as Pall Corporation, L’Oreal, Axiom Pharmaceuticals, Johnson and Johnson and Nobel Biocare. He is the owner of IQA Consulting Services; a niche provider of quality and compliance services to the FDA and similarly regulated industries. Jan has extensive experience working for Fortune 500 as well as start-up companies.
His expertise encompasses the following:
FDA regulated product manufacturing, packaging, Quality Assurance, Laboratory Operations and Regulatory Affairs.
Creation, implementation and management of Quality Systems for the following standards: GXP, ISO 13485, ISO 22716, ISO 15378, ISO 9001, ICH Q7 and EFfCI
Manufacturing, Quality and Complaint investigations
Training, technical writing and SOP development
CAPA and change control management
FDA Field Alerts, 483s, recalls and consent decree remediation
Supplier, API, contract manufacturing and packaging, internal and third party auditing
Jan received his B.S. in Biology from SUNY Stony Brook and his MS and MBA in Management of Technology from New Jersey Institute of Technology.