FDAnews Announces — Preparing for an FDA Preapproval Inspection Webinar, July 13, 2016

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It’s time for a preapproval inspection and all sites must be prepared. Join industry expert Gaurav Walia on July 13 for a 90-minute webinar where he explains how to prepare for and manage preapproval inspections.

FDAnews

FDAnews

Preparing for an FDA Preapproval Inspection
July 13, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/preparingfdapreapprovalinspection

It’s time for a preapproval inspection.

Are all of the sites prepared?

Don’t let the FDA doubt that the method of analysis or manufacturing practices are what they are claimed to be.

Join industry expert Gaurav Walia on July 13 as he explains how to prepare for and manage preapproval inspections. In 90 minutes he will cover:

  • A risk-based approach to inspections
  • Inspectional activities guidance — from drug development to QA controls to document reviews
  • How to handle document requests

Register today and learn how to prepare for a preapproval inspection and avoid misunderstandings and delays.

Meet the Presenter:
Mr. Gaurav Walia, M.S. has over 17 years of Pharmaceutical experience with careers at Monsanto/Searle, Pfizer/Oread, Forest Laboratories, and others while also serving as a Pharmaceutical Consultant in various disciplines from Quality Systems, R&D, CD, CSV, Vendor Certification etc. Mr. Walia has managed various technical, quality and compliance groups, such as but not limited to, Pharma R&D, Laboratory Information Management Systems (LIMS), Metrology, Quality Control (QC), Materials Import and Export, Safety, New Facility Design, Validation and Commissioning, Capital Budget (Instrument and Equipment Acquisition from R&D to Commercial), Operating Budget (All Service contracts), Regulatory Compliance, etc.

Who Will Benefit:

  • Compliance Officers
  • Executive Management
  • General/ Corporate Counsel
  • Regulatory/ Legislative Affairs Professionals
  • Risk Management Specialist
  • Sales and Marketing Personnel
  • Training Personnel
  • Medical Science Liaisons
  • Outside Attorneys

Webinar Details:
Preparing for an FDA Preapproval Inspection
July 13, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/preparingfdapreapprovalinspection

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/preparingfdapreapprovalinspection        
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
+1 (703) 538-7665
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