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EVENT DATE
Jul 2016
M T W T F S S
18192021222324
EXPO DATE
Jul 2016
M T W T F S S
18192021222324

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Online Event
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Type: Online Event

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Avoid Warning Letters in View of the U.S. FDA's Stated Goal - By AtoZ Compliance

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EVENT DESCRIPTION

Key Take Away:

Learn how to minimize the chance of receiving an FDA Warning Letter, what to doing during and after an FDA compliance audit to avoid common areas for critical mistakes.

Overview:

FDA Warning Letters and recent high-profile recalls indicate major cGMP training deficiencies in many companies.

Why Should You Attend:

Targeted cGMP issues. How can a company proactively minimize the chance of receiving a Warning Letter? Areas a company "must review" beforehand. What to doing during an FDA compliance audit training?

What to do immediately after the audit? What to do during the response period. Lessons learned.

Areas Covered In This Webinar:

  • The U.S. FDA's new aggressive implementation plans 
  • Proactive reviews of the applicable U.S. FDA / cGMP guidelines
  • Key areas to focus limited resources

Learning Objectives:

  • FDA Inspectional objectives
  • Common areas for critical mistakes
  • Recent trends and events
  • The compliance audit

Who Will Benefit:

  • Senior Management
  • Project Leaders
  • Regulatory Affairs 
  • Quality Systems Personnel
  • Internal and Supplier Auditor Personnel
  • R&D and Engineering Staff
  • CAPA and P&PC Personnel
  • Speakers Profile:

John E. Lincoln
John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 33 years' experience in U.S. FDA regulated industries, 19 of which are as an independent consultant. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D).

For more detail please click on this below link:

http://bit.ly/1PBs7x1

Email: support@atozcompliance.com
Toll Free: +1- 844-414-1400
Tel: +1-516-900-5509

Fax: +1-516-300-1584

Contact the event managers listed below for more information about how you can participate at the Avoid Warning Letters in View of the U.S. FDA's Stated Goal - By AtoZ Compliance.

EVENT CONTACTS

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EVENT DETAILS

Primary Industry:
Healthcare General
Other Industries:
Healthcare General, Professional Healthcare
Audience:
Senior Management
Project Leaders
Regulatory Affairs
Quality Systems Personnel
Internal and Supplier Auditor Personnel
R&D and Engineering Staff
CAPA and P&PC Personnel
Notes:
Show Owner:
AtoZ Compliance
Sponsorship: Yes

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AtoZ Compliance

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