FDAnews Announces — FDA Inspection Intelligence: New Focus on Data Integrity and cGMP Compliance Webinar, March 7, 2018

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Drug and biologics makers are facing an FDA data crackdown with inspectors digging deeper into data integrity issues amid rising concerns over Forms 483 and warning letters. Former Deputy Director of OCBQ, CBER, Mark Schwartz Esq. brings an insider perspective to shifts within the agency.

FDA Inspection Intelligence:
New Focus on Data Integrity and cGMP Compliance
**An FDAnews Webinar**
March 7, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/fdainspectionintelligence    

Drug and biologics makers are facing an FDA data crackdown. Inspectors are digging deeper into data integrity issues amid rising concerns over Forms 483 and warning letters.

FDAnews has reached out to the former Deputy Director of OCBQ, CBER. Mark Schwartz Esq. brings an insider perspective to shifts within the agency.

Mark the calendar for Wednesday, March 7, when Mr. Schwartz, now a lawyer in private practice with Hyman, Phelps & McNamara, a leading Washington regulatory firm, shares inspection-passing knowledge including:

  •     Background: Why the FDA is stepping up pursuit of data integrity issues now
  •     The product adulteration threat: How FDA is invoking the FDASIA provision when companies balk at inspections
  •     Sec. 704(a)(4): Why the agency may invoke this provision regarding advance request of records or in lieu of an inspection
  •     The draft Quality Metrics initiative: Where it stands
  •     And much more!

This is a chance to pick the brain of a CBER ex-insider, still intimately involved in agency affairs as a lawyer in FDA practice.

Meet the Presenter:
Mark I. Schwartz Esq., Director, Hyman, Phelps & McNamara, is the former Deputy Director of OCBQ, CBER. In a 13-year FDA career, Mr. Schwartz also worked closely CBER’s Division of Manufacturing and Product Quality and Division of Biological Standards and Quality Control, and served as Associate Chief Counsel of the FDA. Now in private practice, he advises clients on drug, biologic and device compliance, chemistry, manufacturing and control, and combination products, and has served as an expert witness in FDA-related litigation.

Who Will Benefit:
This session is appropriate for anyone concerned with quality and inspections at pharmaceutical and biologics facilities, including:

  •     QA/QC
  •     Regulatory/compliance
  •     cGMP/manufacturing
  •     Data analysis
  •     Legal counsel

Webinar Details:
FDA Inspection Intelligence:
New Focus on Data Integrity and cGMP Compliance
**An FDAnews Webinar**
March 7, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/fdainspectionintelligence    

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/fdainspectionintelligence                                                                                        
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.

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Michelle Butler
FDANEWS
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