Falls Church, VA (PRWEB) October 31, 2014
FDAnews Inspection Insider
Those who have been in the drug and device business for a while know one thing: every investigator who arrives at the plant will have their own way of doing things. Whether they work for the FDA, the EU, Japan’s PMDA or China’s CFDA, no visit will be the same.
Even though regulations and guidances give a framework for how the inspection will go, there’s the reality of what’s actually happening in the field:
- The devicemaker whose surprise inspection consisted of the investigator spending 90 percent of his time grilling employees on SOPs;
- The drugmaker whose Indian facility had investigators from the US show up at the door unannounced for the first time ever;
- The devicemaker whose China suppliers are seeing half of their inspections result in 483s and warning letters; or
- The drugmaker who had the FDA bypass the SOPs altogether and make a beeline for the laboratory data system to look at testing data that seemed “too good.”
How does FDAnews know these issues are plaguing drug and device companies? Because each week their reporters spend hours talking to the quality managers at recently inspected facilities, surveying them about what happened during the inspection and what caught them by surprise.
And now FDAnews is launching a new service that reports on these findings, bringing subscribers the latest inspection intelligence every week.
Introducing FDAnews Inspection Insider, designed to help manufacturers stay on top of regulatory inspections worldwide.
Why wait? Open the door to the information service that can make a difference in FDA inspections.
Subscribe to Inspection Insider before Nov. 15, 2014 and receive a bonus DVD, Face to Face with FDA Investigators.
This 135-minute DVD features six current and former FDA investigators offering candid answers to the most pressing questions about topics such as:
- Is an investigator entitled to see a company’s internal audit reports?
- Should a manufacturer hire a former FDAer as an inspection consultant?
- What should manufacturers do while the investigator has to wait for document retrieval?
- Will investigators view a company’s website and YouTube channel while preparing for the inspection?
- And much more
This informative Q&A discussion, a favorite of attendees at FDAnews’ Inspections Summit is a $497 value, and it’s free with membership to FDAnews Inspection Insider.
FDAnews Inspection Insider
Price: Special Introductory Offer $997; Regular Price: $1,297
Easy Ways to Order:
By phone: 888-838-5578 or 703-538-7600
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.