04.25.17
The United Natural Products Alliance (UNPA) is launching a new training series, “Beyond GMPs: Mastering The Key Elements Of Dietary Supplement Quality Before Your Next FDA Inspection or Audit,” to be taught by former FDA investigator, Larisa Pavlick, UNPA’s vice president of global regulatory and compliance.
The two-day training course will be held in Provo, UT, June 27-28, and will address the key elements of dietary supplement quality: identity, purity, strength and composition, which manufacturers will need to master to be in full compliance with good manufacturing practices as mandated by the Dietary Supplement Health and Education Act.
Ms. Pavlick, who has been in more than 200 facilities on behalf of FDA in her role as an investigator, will share her FDA knowledge and experience to help industry companies achieve the level of quality FDA requires during facilities inspections. The training will cover all pertinent inspection topics, including:
“This training is the culmination of UNPA’s many years of promoting best practices for the dietary supplement industry,” said Loren Israelsen, UNPA president. “To our knowledge, no one is offering a comprehensive GMP training program that includes the experience and insights of a former FDA investigator. We are pleased to be able to offer this unique training to the UNPA membership and to the industry.”
“One of the reasons I joined UNPA was to be able to help companies be prepared for FDA audits and to provide them actionable, in-the-trenches resources to do just that,” said Ms. Pavlick. “This training will enable industry companies to be fully prepared to complete a successful FDA inspection, which will also enable them to be prepared for all customer and certifier audits.”
For more information, including the full training agenda, lodging information and to register, visit www.unpa.com/events.
The two-day training course will be held in Provo, UT, June 27-28, and will address the key elements of dietary supplement quality: identity, purity, strength and composition, which manufacturers will need to master to be in full compliance with good manufacturing practices as mandated by the Dietary Supplement Health and Education Act.
Ms. Pavlick, who has been in more than 200 facilities on behalf of FDA in her role as an investigator, will share her FDA knowledge and experience to help industry companies achieve the level of quality FDA requires during facilities inspections. The training will cover all pertinent inspection topics, including:
- The state of the industry, including trends, regulatory actions, 483 Observations and new regulations
- Understanding the laws, regulations and guidance documents
- A review of the FDA Establishment Inspection (EI)—section by section—and how to be prepared
- Facilities registration
- The Request for “Written Procedures”
- Manufacturing Operations—a section by section review
- Understanding the quality control section in the Compliance Program
- The FDA Product Review: Expectations and establishing release criteria
- Attachment E and raw materials of special interest
- The close-out meeting
- Preparing a written response to an FDA 483
- EI classifications and what to expect post-EI
- FSMA: Are you ready?
- And much more.
“This training is the culmination of UNPA’s many years of promoting best practices for the dietary supplement industry,” said Loren Israelsen, UNPA president. “To our knowledge, no one is offering a comprehensive GMP training program that includes the experience and insights of a former FDA investigator. We are pleased to be able to offer this unique training to the UNPA membership and to the industry.”
“One of the reasons I joined UNPA was to be able to help companies be prepared for FDA audits and to provide them actionable, in-the-trenches resources to do just that,” said Ms. Pavlick. “This training will enable industry companies to be fully prepared to complete a successful FDA inspection, which will also enable them to be prepared for all customer and certifier audits.”
For more information, including the full training agenda, lodging information and to register, visit www.unpa.com/events.
