What homeopathic manufacturers need to know, and what the FDA wants to see.

By Eric Foxman, AAHP Secretary

Late last month, I joined Mark Vermette and Lyn Agostinelli of Halloran Consulting Group as they prepared for our upcoming Compliance Thru Education webinar: Document Control. I heard their presentation points and had a glimpse at their presentation materials. Simply put, they are packing a lot of information into a one-hour session for our industry.

Document Control can’t be viewed as a standalone topic. Lyn and Mark wove Standard Operation Procedures (SOP) and Document Management together as a congruent whole from a perspective of integration and simplification. I was particularly impressed with how they tied the two together both in terms of regulatory realities and a practical overview of implementation.

I suppose I am as guilty as others when I think of SOP and Document Control as pertaining to manufacturing and quality departments with websites being in the realm of marketing. Thus, I found their statements regarding website development in this context totally eye-opening. I think just that section of their presentation will make it worthwhile to attend the webinar.

For the webinar, Lyn and Mark will share their decades of firsthand experiences regarding FDA’s expectations of documentation during inspections. It will be only an hour-long webinar, but the two will also provide a wide variety of points to consider regarding solutions to these regulatory issues facing our industry.

It is very rare that I get a chance to hear and see one of our webinars ahead of time. I and another AAHP Board member had the opportunity to provide Lyn and Mark with feedback and insights into the homeopathic industry so they could tailor their presentation to our audience. I found them open, receptive and really listening to learn what will be most helpful for you to hear.

Based on what I experienced, I can say: you and your management staff won’t want to miss this information-packed session. Join us for AAHP’s upcoming Compliance Thru Education Webinar on Document Management on Thursday, Sept. 8, 2016, at 1:00 pm EDT • 12:00 pm CDT • 11:00 am MDT • 10:00 am PDT. Click here to register.