Tuesday, 12 December 2017Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions
Unforeseen, unanticipated, unpredicted, unexpected. These are frightening words to pharmaceutical quality and compliance professionals because an unexpected event often indicates a costly, risky problem; it means that something is not completely under control.
This, of course, has regulatory implications. One familiar regulatory example is 21 CFR 211.192: “Any unexplained discrepancy…shall be thoroughly investigated…The investigation shall extend to other batches…that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and follow-up.”
Friday, 08 December 2017Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions
The road to regulatory compliance for Combination Products has been a long one, and we’ve not yet arrived at our final destination.
At a recent AdvaMed Workshop in Washington DC, Pilgrim Quality Solutions, alongside FDA experts, had the privilege to present a Past, Present and Future perspective on Combination Products, diving into topics such as Product Registration (PMA, 510K); the De Novo pathway for Combination Products; Requests For Designation (RFD); Primary Mode of Action (PMOA); Labeling and Cross Labeling of Combination Products; CGMP; Adverse Event Reporting and Post Market Safety Reporting; and, Combination Product Inspections and Quality System Regulations.
Thursday, 30 November 2017Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions
Last week’s post was the first in a two-part series on practical tips for managing supplier risks in the life sciences industry. In the previous post
we discussed how resource planning, understanding the rules, preparation, and planning lay the foundation for a successful supplier-risk management program. In today’s post we’ll provide practical tips for setting goals, coaching recommendations, and best practices for supplier performance and risk monitoring.
Thursday, 16 November 2017Florian Czaszewicz, Industry Solutions Consultant, Pilgrim Quality Solutions
Recently, I had the opportunity to explore practical tips for managing life sciences supplier risks along with Dr. Carmine Jabri of E.M.M.A. International Consulting Group
, Aida Markham of QACV Consulting
, and Kenneth Christie of VTS Consultants, Inc
. This post is the first in a two-part series where we’ll review key takeaways from Pilgrim’s portion of that webinar and presentation. If you’d like to view the entire webinar, you can watch the on-demand version here
Thursday, 09 November 2017Bernard Jee, Product Manager, Pilgrim Quality Solutions
The U.S. Food and Drug Administration (FDA) announced, on June 8, 2017, that updates and changes are being made to its Electronic Submission Gateway (ESG) system for electronic medical device reporting (eMDR). If you are not subscribed to the FDA listserv
, this information may not be readily available unless you visit the FDA Gateway website
to see the full list of the planned updates.
In the interim, there are key updates that will impact various components of the submissions process.