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FDA Penalties for Regulatory Non-Compliance in the Pharmaceuticals Industry - 2017 in Review

GlobalCompliancePanel

Course

In Chicago ()

£ 1,197.93 VAT inc.

*Indicative price

Original amount in USD:

$ 1,495

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Description

  • Type

    Seminar

  • Level

    Advanced

  • Class hours

    9h

  • Duration

    2 Days

FDA Penalties for Regulatory Non-Compliance

The FDA is increasing its enforcement actions both for domestic and foreign inspections. Enforcement statistics have not been summarized yet because 2017 has not ended yet. We are certainly seeing more Warning Letters and Import Alerts based on Data Integrity (21 CFR Part 11: Electronic Records; Electronic Signatures. In the past FDA used to issue several Warning Letters to the same firms upon consecutive inspections. Today, after receiving one Warning Letter the next regulatory action is elevated to Import Alert, Consent Decree, and Injunctions for domestic manufacturers.

About this course

This hands-on seminar provides a comprehensive approach to learning how to proactively prevent non-compliance. There will be intensive reviews on the negative consequences of receiving regulatory enforcement actions. FDA Warning Letters are posted publicly on the CDER web site. Your competitors, shareholders, the public and your patients now become aware of your shortfalls. Many Warning Letters today mandate the hiring of third party consultants, which can be quite expensive. An Injunction will require pharmaceutical companies to spend millions of dollars and require years until you "bounce back." Multimillion disgorgement penalties are being levied along with Injunctions.

CEOs
VPs
Compliance Officers
Attorneys
Complainant Managers
Managers (RA, QA/QC, CA)
Consultants
Contractors and Subcontractors
Anyone interested in the topic
Quality Control Personnel & Management
Manufacturing Personnel & Management
Senior Management
Regulatory Affairs Personnel & Management
Quality Assurance Personnel & Management
Supplier Quality Personnel & Management
Quality Managers
Project managers
Senior management for companies developing new products for US market
Regulatory affairs professionals
People investing in FDA-regulated products intended for the US market
Operations, Plant and Facility Managers

Questions & Answers

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Reviews

Subjects

  • Fda
  • FDA perspective
  • Regulatory Affairs
  • Regulatory
  • Regulatory Compliance
  • Pharmaceutical Management
  • Pharmaceutical laboratory administration
  • Healthcare
  • Food safety
  • Compliance
  • Quality

Teachers and trainers (1)

Brian G. Nadel

Brian G. Nadel

President/Sole Proprietor

Brian G. Nadel President/Sole Proprietor of Brian G. Nadel, GMP Consulting, LLC Brian G. Nadel is the President/Sole Proprietor of Brian G. Nadel, GMP Consulting, LLC. He has over twenty-five years of diverse experience in: Pharmaceutical Quality Assurance and Quality Systems; FDA Pre-Approval and Inspection Readiness Inspections; International CGMP Auditing for finished drug products, Active Pharmaceutical Ingredients, Fermentation, Process Validation and botanical extraction.

Course programme

Day 1 ScheduleLecture 1:

Introduction and Background

  • Introductions / Participants' Understanding / Participants' Objectives for the Course (Please come prepared to discuss)
  • Background
  • Industry Context
  • Key Concepts
Lecture 2:

Summary and Highlights of 2017 Enforcement Actions

  • Warning Letters
  • Import Alerts
  • Consent Decrees
  • Injunctions
Lecture 3:

Penalties and Negative Financial results of Enforcement Actions

  • Detailed Costs and Expenditures for Remediation
  • Loss of Sales and Customers
  • Decreases in Patients Access
  • Loss of Good Reputation
  • Loss of Jobs
Lecture 4:

ICH Guidelines on Quality Risk Management

  • Science Based Quality Risk Management
  • Quality Risk Management Process
  • Initial Risk Assessment
  • Implement & Verify Appropriate Controls
  • Review Risks & Monitor Controls
Day 2 ScheduleLecture 5:

Adequate Responses to FDA

  • Comprehensive Corrective and Preventative Action (CAPA) Plans
  • Sincere and Specific timelines
  • Quarterly Follow-ups
  • Adequate but not overwhelming documentation
  • Training
Lecture 6:

Change in Attitude and Culture

  • Full Support and Commitment of Senior Management
  • Responsibilities to Customers
  • Proactive Not Reactive
Lecture 7:

Metrics on Improvements

  • Management Involvement
  • Personnel Involvement
  • Positive Increases in Metrics Lead to Positive Attitudes
  • Incentives and Acknowledgements
Interactive Session:

Group Activities Writing FDA-483 Responses

  • Instructors Evaluation and Recommendations

Additional information

Contact us today!
NetZealous LLC DBA GlobalCompliancePaneljohn.robinson@globalcompliancepanel.com   support@globalcompliancepanel.com  Toll free: +1-800-447-9407Phone: +1-510-584-9661 Website: http://www.globalcompliancepanel.com
Registration Link - https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901471SEMINAR?SEO-2018-march-emagister
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See related categories

FDA Penalties for Regulatory Non-Compliance in the Pharmaceuticals Industry - 2017 in Review

£ 1,197.93 VAT inc.

*Indicative price

Original amount in USD:

$ 1,495

The best Other Health courses

See all

See all