About FDA Penalties for Regulatory Non-Compliance 2018
FDA Penalties for Regulatory Non-Compliance in the Pharmaceuticals Industry - 2017 in Review will be started on 29 Mar and it will be ended on 30 Mar 2018.
The invites you to Chicago, Illinois for FDA Penalties for Regulatory Non-Compliance in the Pharmaceuticals Industry - 2017 in Review. It will take place at Hilton Garden Inn Chicago OHare Airport.
At the time of the meetings of FDA Penalties for Regulatory Non-Compliance 2018, you are going to have the last updates and exact info concerning Pharmaceutical, Medical Devices and Medical Regulation issues.
FDA Penalties for Regulatory Non-Compliance 2018 is organized three times a year.
The organizer of the FDA Penalties for Regulatory Non-Compliance 2018, FDA Penalties for Regulatory Non-Compliance in the Pharmaceuticals Industry - 2017 in Review is Global Compliance Panel.
When you are in Chicago for FDA Penalties for Regulatory Non-Compliance 2018, uncover these three must visit parts and adore the enchantment of this city:
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. Senior Management must take the initiative in setting the tone of full compliance: Taking "regulatory risks" may no longer be worth the price of getting caught Planned deviations cannot be used as an excuse for not following your written procedures Retesting into compliance has been unacceptable for many years and will no longer be tolerated Senior officials are being held responsible. Today, these "Captains" may go
Important Dates
Day 1 Schedule Lecture 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 Schedule Lecture 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 Lectu
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