Currently there are no upcoming 21 CFR 121 Food Defense Plans for the Dietary Supplement Industry courses scheduled. Contact us to find out when the next course will run or if you need customized training. We can deliver this course and a broad range of other training topics at your location, off-site or virtually.Contact us
Food defense is a new area of compliance for the food industry and includes dietary supplement manufacturers. This training is an introduction to the 21 CFR 121 regulation focusing on how to create a compliant food defense plan for the dietary supplement industry as required by the FDA. This convenient short online training delivers extensive industry experience, real-world case studies and sample worksheets for immediate use with your business.
On completion of this course, you will know and understand:
You will also receive FDA references and guidance documents.
Course instructors will be selected from the following:
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 has 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.
Jennifer Alfrey - Jennifer has a master’s degree in nutrition and over 25 years of experience in the dietary supplement and cosmetic industries. Her experience ranges from product innovation to global regulatory compliance with experience in formulating, developing, and registering nutrition and cosmetic products in over 150 different countries.
Jennifer has also successfully built cGMP compliant quality management systems from the ground up for dietary supplement manufacturing operations. She has launched quality systems that include compliant documentation of procedures, MMRs, specifications, complaints, laboratory testing, test method development and manufacturing processes.