ComplianceOnline

Responding to 483s and Warning Letters

Instructor: Ashish Talati
Product ID: 700213
Training Level: Intermediate to Advanced
  • Duration: 60 Min

recorded version

$249.00
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
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CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

In this FDA compliance training will discuss the important tips on how to respond to both 483s and Warning Letters in an effective way and how to avoid common pitfalls.

Pharmaceutical, biotech, medical device and generic drug companies will be most interested in attending this program. At the conclusion of an FDA inspection (see prior webinar FDA Inspections-Dos & Don’ts), FDA investigators issue a form FDA 483 which lists the adverse observations made during the inspection.

Following review of the 483 and the establishment inspection report (EIR), the FDA District Office may elect to send the inspected company a Warning Letter. No company ever wants to receive a Warning Letter and/or Form 483 from the US Food and Drug Administration (FDA). However, a 483 or a Warning Letter from the FDA doesn’t have to be a nightmare. By effective and timely communication with the FDA, developing well thought out corrective action plans, and by following through to make certain actions have been carried out as promised, companies can reduce or eliminate the risk of further regulatory action. It is important to prepare and respond to each of these situations carefully and thoughtfully. Failure to properly act in these situations could possibly result in business being shut down, criminal/civil actions being filed, and/or huge financial losses. The seminar teaches important tips on how to respond to both 483s and Warning Letters in an effective way and how to avoid common pitfalls.

Areas Covered in the seminar:

  • 483s and Warning Letters
  • Challenging/Disputing a 483
  • Timeliness Of Response
  • Drafting effective response letter
  • Avoiding Common Pitfalls

Who Will Benefit:

  • Regulatory Affairs
  • Quality Assurance/Control
  • Plant Management
  • Auditing
  • Engineering
  • Research & Development
  • Quality Systems Management
  • Documentation Management
  • VPs, Directors and Heads of: Quality Assurance, Compliance, Validation & Regulatory Affairs

Instructor Profile:

Ashish Talati, is an Associate at Amin Law, LLC. whose key practice areas include Food and Drug Administration (FDA), Federal Trade Commission (FTC), U.S. Customs, U.S. Drug Enforcement Agency (DEA), U.S. Department of Agriculture (USDA) and related Federal and State regulatory compliance and litigation matters, advertising law, intellectual property including patents, trademarks, copyrights, trade secrets and licensing, contracts, and business litigation. Ashish R. Talati primarily counsels companies and trade associations in the pharmaceutical and biotechnology industry on a wide range of issues surrounding U.S. Food and Drug Administration’s (FDA) review, approval, and oversight of drug and biological products. He counsels such drug and biotechnology clients as well as food, dietary supplement, cosmetic and medical device companies on matters of regulatory compliance, helps them anticipate and address regulatory issues in their day-to-day business operations and strategic planning, and advocates on their behalf before the FDA, FTC, Customs, USDA, DEA and other federal and state agencies, and in court.

Mr. Talati has significant experience managing compliance and crisis situations and frequently speaks at industry conferences and seminars. Mr. Talati has provided training to consultants on various FDA related regulations including 21 CFR Part 11, GxPs, HIPPA, PDMA, DSHEA etc. Mr. Talati has consulted on regulatory issues for over 6 years assisting major pharmaceutical and biotechnology companies in assessing their compliance programs and in reviewing and revising policies and procedures governing compliance with the FDA’s rules and regulations.

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