Enclosed are a series of upcoming microbiological webinars which are being offered between now and the end of September. While many of us are working from home or in the office on a limited basis, this represents a great opportunity to either gain new skills or refresh those that may require refreshing. Just click on the title of each webinar to gain additional information or … [Read more...]
U.S. Food and Drug Administration (FDA) Inspection Cites Chinese Firm for API Issues – Includes Import Alert and Warning Letter
The U.S. Food and Drug Administration (FDA) inspected manufacturing facilities,  Changzhou Jintan Qianyao Pharmaceutical Raw Materials, from February 13-17, 2017. As a result of significant deviations from current good manufacturing practice (CGMP), the FDA placed the firm on Import Alert 66-40 on May 4, 2017. Subsequent to … [Read more...]
Frequently Asked Questions (FAQ) About Combination Products
Recently the Office of Combination Products published a list of ”Frequently Asked Questions (FAQ)” that are often asked of the Office. This list of approximately twenty eight questions include several questions with rather obvious answers as well as questions that include where to obtain additional information regarding annual reports. The list includes the roles of the … [Read more...]
Quality Metrics and Risk Based Inspections
FDA’s Request for Quality Metrics (New Proposed Guidance July 2015) and Its Basis – The FDA’s Safety and Innovation Act (FDASIA) A Live, Interactive Training Webinar; See: http://www.tungstenshield.com/barry-a-friedman-phd/ Date: Tuesday August 18, 2015 Time: 9:30 - 11:30 AM ET (New York Time) Instructor: Barry … [Read more...]
INSPECTION TRACKER: DRUG MANUFACTURING ESTABLISHMENTS (CANADA)
Health Canada Begins Publishing Information Regarding Emerging Issues As part of Health Canada's ongoing commitment to openness and transparency, the Department recently began publishing information regarding emerging issues identified through the drug inspection program. This Inspection Tracker provides a snapshot of the potential health and safety issues Health Canada … [Read more...]
