EAS Presents Summer Webinar Series on Regulatory Topics Pertaining to Cannabis, Foreign FDA Inspections and Temporary Marketing Permits

Quality Systems for the Cannabis Industry – Preparing for State GMPs

Tara Lin Couch Ph.D., Senior Director for Dietary Supplements and Tobacco Services, will present a webinar on August 6, 2018, at 1:00 pm Eastern to help cannabis firms prepare for cannabis Good Manufacturing Practices (GMPs). Titled “Quality Systems for the Cannabis Industry, Preparing for State GMPs”, she will discuss how GMPs applications to this unique industry cannot be understated. While regulations vary from state to state the quality systems under which cannabis products are grown and manufactured have similarities that can begin to pave the way for putting practices and procedures in place to meet compliance expectations, including those of testing and quality control of in-process materials, finished batches and packaged/labeled products. The time is right for the cannabis industry to begin assessing manufacturing processes and implementing sound and effective quality systems in order to begin preparing for GMP regulations. Stay ahead of the curve, standardize your product quality and be a leader in your industry. Join Tara on August 6, 2018, at 1:00 pm Eastern for this free webinar by clicking here.

Preparing for Foreign FDA Inspections

Have you ever wondered why your foreign suppliers: API, intermediates, food ingredients, etc. are suddenly in trouble with regulatory authorities? Did they just go astray or is your auditing program not performing as designed? Actually, there are several things at play. EAS Independent Consultant, Peter Saxon, will shed some light on reasons FDA inspections can “go south” as well as provide insight on how disappointing results can be managed. Saxon has personally attended 90 FDA inspections of foreign facilities and another 15 inspections by other regulatory agencies (TGA, WHO, EDQM). His insights will provide an opportunity for companies to consider improvements to their internal audit structure to help minimize regulatory risks. Join us August 14, 2018, at 1:00 pm Eastern for a free webinar on Preparing for FDA Inspections where you will learn where most regulatory problems are found by the FDA, how OAI (Other Action Indicated) results are categorized by the FDA and what you can do to avoid these disappointing results.

Temporary Marketing Permits – Opportunity and Pitfalls of the Specialized FDA Application

Food Standards are an important component of FDA’s oversight, ensuring honesty and fairness to the consumer through requirements that provide for the basic nature of a standardized food to be uniform in terms of its characteristics as well as the ingredients that it must or may contain. But what happens when a newly developed food or production method warrants consideration of a product category outside of the standard? Petitioning to amend a food standard or to create a new one, is a lengthy and complicated process; however, a temporary solution may be available through a specialized category called a Temporary Marketing Permit (TMP’s). With TMP’s companies with novel standardized food innovations may apply to market test a food product that deviates from the standard of identity for that particular food, providing FDA with data needed to consider a future petition to amend the standard. Join Independent Consultant April Kates, on August 21, 2018, at 1:00 pm for this informative webinar on Opportunities and Pitfalls of Temporary Marketing Permits where you’ll learn best practices for submitting a successful TMP application.

Posted in 2018 July, EAS in Action.