Foreign Supplier Verification Program Failures – FDA’s Number One FSMA Citation
Foreign Supplier Verification Program Failures – FDA’s Number One FSMA Citation Presented by EAS Independent Consultant, Carlos Ortiz July 15, 2021, 1:00pm eastern Did you know that FSMA requires an established FSVP that places the onus of compliance verification for...
PMTA Deficiency Letter Readiness and Response Preparation
PMTA Deficiency Letter Readiness and Response Preparation Part 2 of a special series focusing on CTP’s requirement of PMTA submissions With Willie J. McKinney, Ph.D., Scientific Advisor for Labstat International and CEO and Founder of McKinney Regulatory Science...
Medical Device or a Wellness Device?
Wellness devices are big business, creating an accountability partner for the user and providing real-time data to their medical provider. But where does a wellness device cross the line to a medical device and what does that mean for the manufacturer? From design, to claims to special
EPCRA SARA SDS RCRA An Alphabet Soup and Customer Notifications Post FDA Regulations
Ingredient suppliers have an alphabet soup of compliance requirements, beyond those of FDA. From EPA to OSHA to even DOT, all product ingredients are regulated depending on the hazards
Scientifically Sound Specifications – No “By-Inputs” Here
Learn how to develop scientifically sound Finished Product Specifications, even when no analytical test method is available to test the final product. An EAS Complimentary Webinar June 8, 2021 at 1pm eastern presented by Steve Cammran, Ph.D., Independent Consultant.