FDAnews Announces: 10th Annual FDA Inspections Summit, Nov. 4-6, 2015, Bethesda, MD

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• USA - English

Falls Church, VA (PRWEB) August 21, 2015 -- 10th Annual FDA Inspections Summit
**Presented by FDAnews**
Nov. 4-6, 2015 – Bethesda, MD
http://www.fdanews.com/fdainspectionssummit

What’s the state of FDA’s Quality Metrics Initiative? When will drug and devicemakers have to start collecting data? What will they have to track?

What’s the status of the FDA’s mutual inspection program with Europe?

Data Integrity – Is complacency putting companies at risk?

And what are ORA’s Office of Enforcement priorities for 2016

Get those questions answered and many more, at the 10th Annual FDA Inspection Summit, sponsored by FDAnews.

With twin tracks for drug/biologics and device manufacturers, attendees will discover sessions and panels for every FDA-regulated company.

• For drug and biologics makers, there’s a standout panel on understanding OPQ’s new inspection and reporting plan and organizational structure.
• Devicemakers will hear first-hand progress on the Medical Device Single Audit Program from the FDA’s Kim Trautman, who will share lessons learned from the pilot program. Devicemakers will learn what to expect from an audit and how multiple sites should be audited.
• All attendees will learn from FDA experts who will share proven secrets to help them pass their next FDA inspection with flying colors.

The people attendees want to see are right there in the room, rubbing elbows. Multiple FDAers have been invited including:

• Janet Woodcock, Director, CDER, FDA
• Melinda Plaisier, Associate Commissioner for Regulatory Affairs, Office of Global Regulatory Operations and Policy, ORA
• Kimberly Trautman, Associate Director, International Affairs, Medical Device International Quality Systems Expert, Office of the Center Director, CDRH
• Phil Pontikos, CSO, National Device Expert, OMPTO, ORA, FDA
• Dr. Neil Stiber, Operations Research Analyst, Office of Strategic Programs, CDER, FDA

Plus many former FDA insiders have been invited among the private-sector panelists:

• Former Los Angeles District Director Elaine Messa, head of the Medical Device Practice at Becker & Associates Consulting
• Former FDA investigator Vicky Stoakes, now President, IntegRx
• Former FDA Deputy Associate Commissioner for Regulatory Operations, Steve Niedelman, now Lead Quality Systems and Compliance Consultant, King and Spalding

These are just a few of the many speakers at this year’s Inspection Summit.

Over two days, attendees will discover solutions to the sort of problems that keep them up at night:

• The FDA’s mutual inspection program with Europe …
• Latest on the FDA’s Quality Metrics Initiative…
• A day in the life of an FDA field investigator: Current and former investigators explain what they look for – and why – and what’s on the horizon …
• Data Integrity: Are companies at risk …
• Update: The International Medical Device Regulators Forum’s single-audit program …
• Curbing 483s: Newest and most successful “learning” methods …
• And much more

Conference Details:
10 Annual FDA Inspections Summit
**Presented by FDAnews**
Nov. 4-6, 2015 – Bethesda, MD
http://www.fdanews.com/fdainspectionssummit

Tuition:
Early Bird Registration (until Oct. 2, 2015): Complete Summit $1,797
Regular Registration (Oct. 3, 2015 on): Complete Summit $1,997
Additional pricing options are available online.

Easy Ways to Register:
Online: http://www.fdanews.com/fdainspectionssummit
By phone: 888-838-5578 or 703-538-7600

About FDAnews
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.

Michelle Butler, FDANEWS, http://www.fdanews.com, +1 (703) 538-7665, [email protected]