Webinar: FDA inspections of homeopathic manufacturing facilities
24 Nov 2016
The American Association of Homeopathic Pharmacists (AAHP) will host an educational webinar on Thursday, 1 December 13:00 Eastern Standard Time (19:00 CET) on best practices for homeopathic manufacturing facilities as they relate to US Food and Drug Administration (FDA) inspections.
The webinar is designed for CEOs and managers responsible for compliance, production and quality assurance. It will be led by Tamara Ely, Senior Policy Advisor in the FDA’s Office of Manufacturing Quality and will examine the FDA’s considerations for inspections regarding compliance in homeopathic medicines manufacturing facilities. Featuring feature case studies and compliance outcomes, the 90-minute program will provide an overview of what homeopathic manufacturers should expect from an FDA inspection of their facility. It seeks to answer the following questions:
- There are six areas the FDA might address in an inspection. Which one is always a part of every inspection?
- What pivotal finding will turn a routine FDA inspection into a regulatory action?
- Considering the range of starting materials for homeopathic drug products, what specific concerns does the Agency have for each kind of material?
AAHP webinars are open to all, and members receive discounted registration. Founded in 1923, AAHP is the leading industry association for the manufacturers, distributors and marketers of homeopathic drugs in the US. It promotes excellence in the practice of homeopathic pharmacy, manufacturing, marketing and distribution by supporting the requirements, criteria and published guidelines in the HPUS, relevant Federal statutes, as well as other industry regulations/compendia to help members provide safe, effective homeopathic medicines to consumers, retailers and healthcare practitioners.