Contract Manufacturing - The Paperwork Trail

  • September 24, 20131:00 P.M.-3:45 P.M. EDT/10:00 A.M.-12:45 P.M. PDT

What Is This?

Digital summits are a new experience in online education, optimized for professionals who need deeper-dive information to help them make key business decisions. These immersive education programs are presented by thought leaders in contract manufacturing, addressing the industry’s top challenges.

As a registered user, you can attend the live event on September 24th to view video content in real time with live Q and A interaction with the presenters, or you can watch the content on-demand after the live event. Our program also offers three contact hours of continuing education.

Inside the Digital Summit platform, users have access to a resource library featuring premium content from INSIDER, along with whitepapers, briefs, and webinar content from the event underwriters. You'll have the ability to create your own profile, pose questions, start a dialogue, download resource material, and much more.

Agenda

  • On Demand

    A Guide to SOPs and Compliance for Dietary Supplement Distributors Laurie Meehan and Rosanne Sylvia-Heeter The Dietary Supplement regulations in 21 CFR Part 111 contain 16 subparts. While only one of the subparts includes the word "Distributing" in its title, at least half of the subparts actually apply to supplement distributors. Standard operating procedures (SOPs) detail a company's processes, and hence, outline how a company implements these regulations. This session discusses SOPs for dietary supplement distribution; how to write them and what they should cover to ensure a company is compliant with the regulations, and can demonstrate that compliance to the FDA.
  • On Demand

    Master Manufacturing and Batch Production Records: The Heart of GMPs Aaron Secrist This session will help marketers as well as manufacturers understand the essential nature of master manufacturing records (MMRs) and batch production records (BPRs) to GMP (good manufacturing practice) compliance. Attendees will come away with an understanding of FDA expectations regarding the required elements of MMRs and BPRs, the relationship between the MMR and BPR, how to audit MMRs and BPRs for compliance and FDA's expectations for having this type of documentation available during an inspection for each business type (manufacturers and own label distributors).
  • On Demand

    The Top Eight Compliance Hot Spots on Your Dietary Supplement Label Brian Frisby There are many ways to be out of compliance on your dietary supplement labels. This session, presented by Brian Frisby, 21st Century Healthcare, and co-presented by the United Natural Products Alliance, will highlight eight dietary-supplement-specific hot spots and how not to get burned.
    • Brian Frisby Executive Director of Quality Services and Regulatory Compliance 21st Century Healthcare
  • On Demand

    Are Your Customer Complaints a Ticking Time Bomb? Ensuring Compliance with Dietary Supplement Adverse Event Reporting Requirements Claudia A. Lewis Claudia A. Lewis, partner, Venable LLLP, will review the requirements regarding adverse events for dietary supplement companies, including complaint intake requirements, recordkeeping requirements, and requirements to report serious adverse events to UFDA. She will provide hands-on, useful information and best practices for companies, including examples of adverse events that FDA considered serious (and reportable), but where the companies disagreed. She will also discuss recent events related to adverse events, trends in FDA enforcement, and the March 2013 GAO report.

Speakers

  • Brian Frisby Executive Director of Quality Services and Regulatory Compliance

    Brian Frisby has more than 25 years’ experience in the Quality, regulatory and product development fields within the dietary supplement industry. He is currently executive director of quality and regulatory compliance for 21st Century HealthCare Inc., Tempe, AZ.

    Frisby currently services as chairman of the Arizona State Chapter of the United Natural Products Alliance (UNPA) and vice chairman of the COMPLI/Standards Committee of the Natural Products Association (NPA).

    Frisby's previous experience includes director of quality and regulatory compliance for Nature’s Way, vice president of operations for Marlyn Nutraceuticals and more recently, more than 13 years with Capsugel, a division of Pfizer.

    Co-presented by the United Natural Products Alliance

  • Claudia A. Lewis Partner

    Claudia A. Lewis is a partner at Venable LLP and concentrates in food and drug regulatory law. She represents clients whose products are regulated by FDA under the Federal Food Drug and Cosmetic Act. Lewis counsels companies, scientists, physicians, nutritionists, health care associations and citizen groups on regulatory compliance issues relating to dietary supplements, over-the-counter (OTC) drugs, homeopathic preparations, medical foods, medical devices, California Proposition 65 and the importation and exportation of FDA-regulated goods. Lewis also advises clients on all aspects of marketing of such products, including USDA regulations governing the use of the term "organic," labeling, advertising, manufacturing and distribution issues. She is also experienced in advising international clients on how to establish a U.S. market for their products.

  • Laurie Meehan Internal Project Manager

    Ms. Meehan has been with Polaris Compliance Consultants, Inc. since 2008. She develops the company’s SOPs and manages the internal training program. She also acts as Polaris’ social media manager and writes the company blog. Prior to joining Polaris, she worked at a major telecommunication R&D company where she provided consulting and training on telecom services, and spoke at numerous industry forums. Ms. Meehan also teaches math at a local university and tutors high school students in math and SAT prep. She holds a BA in Computer Science from La Salle University and an MS in Computer Science from Drexel University.

  • Aaron Secrist Quality and Regulatory Manager

    Aaron Secrist is the quality and regulatory manager at NOW Foods. He has more than 20 years of experience in the dietary supplements industry. Before joining NOW, he provided regulatory consulting services in the industry, including conducting GMP (good manufacturing practice) audits under the Natural Product Association (NPA) GMP certification program. He has also been a speaker at many dietary supplement GMP education seminars under the auspices of the NPA, which he continues to do. Prior to his consulting business, Secrist was the director of quality and R&D for Nature’s Way.

  • Rosanne Sylvia-Heeter Director of GMP Compliance

    Ms. Sylvia-Heeter has over 30 years of GMP, GLP, and GCP quality assurance and compliance experience with Active Pharmaceutical Ingredients, Clinical Research Materials, and Finished Product. During her career, she has developed global quality systems and prepared both domestic and international facilities for FDA Pre-approval Inspections. Ms. Sylvia-Heeter has interacted with the FDA at both the Headquarters and District levels. She has held positions as Compliance Manager, Quality Assurance Manager, and Global Director at major research-based and generic pharmaceutical companies and consulting firms. She is a member of American Society of Quality, Regulatory Affairs Professional Society, and the North Carolina Regulatory Affairs Forum. Ms. Sylvia-Heeter holds a BS in Biology from Loyola University.