Understanding FDA

FDA inspections are typically the starting point for the sequence of enforcement actions, since serious violations discovered at inspections.

Medical & Health Care, Pharmaceuticals/Drug Discovery

Understanding FDA 5 Jun 2014 Minneapolis, Minneapolis, United States
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FDA inspections are typically the starting point for the sequence of enforcement actions, since serious violations discovered at inspections will often result in Warning Letters, which in turn, if not properly responded to, can turn into seizures, injunctions, prosecutions, or recalls or consent decrees. So you can look at the number of inspections as one indicator of how aggressive FDA is being regarding enforcement. The seminar will provide an in-depth overview of the various enforcement actions, with primary focus an emphasis on Warning Letters, Seizures, Injunctions and Prosecutions. However, this seminar address as part of a high-level snapshot a multitude of enforcement actions, including 483/EIR enforcement actions, but not limited to:
• Application Actions
• Certification Withholding or Revocation
• Citation
• Civil Penalty
• Disqualification
• Demand for Destruction
• Emergency Permit Disapproved
• Injunction
• License Action (Denial, Suspension, Revocation)
• Prosecution
• Recall
• Remove from Shippers' List
• Seizure/Detention
We will address FDA enforcement stats in this space with some regularity, trying to discern patterns and trends as related to current state vs. future state. We will address the critical approach necessary to develop a quality remediation plan for inspectional observations (e.g., FDA Form 483/Warning Letter) submitted by FDA. We will examine the importance of having a detailed understanding of the observations and their impact on all quality sub-systems. Management will need to ensure a clear and scientific strategy is developed and communicated to FDA. This is critical to re-establish credibility with FDA and, hopefully, prevent an escalation to a Warning Letter or injunction (i.e., Consent Decree). There are also important technical writing and formatting rules that should be followed when writing one's response. Inadvisable response strategies and deficient remediation efforts will be discussed. Ultimately, the hard work in developing a quality remediation plan will help ensure FDA does not proceed to enforcement actions such as a Warning Letter or worse.
Why should you attend?
• Address different types of Warning Letters
• Understanding FDA's enforcement strategy and what it means to your firm
• Understanding how auditors think and their expectations
• Being prepared to receive regulatory inspections
• Recognizing when inspectional findings or events indicate potential regulatory actions
• When to take or not immediate action during an inspection
• Making better responses to FDA both during and following inspections
• How to make written procedures and training more effective
• How to increase the effectiveness and efficiency of internal audits
• How to identify effective compliance metrics
• Seminar attendees are encouraged to bring examples of their work from the functional area on the various topics as applicable for group discussion as applicable
• Review and discuss pain points, challenges and solutions
• Understand the use of FDA's Administrative Enforcement Tools
• Inspectional Options based on Inspectional Violations
• Current FDA Enforcement Priorities: Application and Data Integrity PolicyAddress Civil and Criminal Penalties
• Collateral Damage
• Keys to Compliance Programs
• Why Does FDA Enforce
• FDA's New Enforcement Culture
• FDA's Expectation on Replying to Inspections and Warning Letters
• How to Handle the Inspection
• Lessons Learned from the Actual Response
• How to Avoid Adverse Inspections and Warning Letters - its simple - COMPLY!
• Learn the methodology and strategy behind Warning Letters, Seizures, Injunctions/Consent Decrees) and Criminal Prosecution
• Understand what the OIG does as an enforcement body with FDA and the latest trend with CIA (Corporate Integrity Agreements)
• Why Recalls are an example of an Enforcement Tool
• Identify and discuss the latest FDA and industry trends with statistics and data regarding enforcement and inspection data
• Leave the seminar with a better understanding of FDA's new approach to inspections and why state of readiness and preparation are business critical going forward
Areas Covered in the Session:
FDA History, Inspectional Strategy and Techniques
1. SOPs
2. Training
3. Audits
4. Managing the Inspection and State of Readiness
5. Responding to FDA Inspectional Observations (483s)/Warning Letters
6. Mock Inspections
Warning Letter and Notice of Violation Responses
1. Strategy and Remediation Implementation
2. Drafting
3. Liaison with FDA to ensure Close-out
Formal Enforcement
1. Import Detentions
2. Seizures
3. Injunctions and Consent Decrees
4. Criminal Prosecutions
5. Application Integrity Policy
1. Assessing need for recalls
2. Implementation
1. Risk classification process
2. Logistics
3. Managing Product Liability Risks
Who Will Benefit:
This seminar will provide an overview and in-depth snapshot of the process for preparing for and managing an FDA inspection efficiently, effectively and successfully. Employees who will benefit include all levels of management and departmental representatives from key functional areas and those who desire a better understanding or a "refresh" overview of the FDA inspectional process, strategy, the tools to be used to assess and gauge state of preparation and readiness, including:
• Managers responsible for GMP/GLP/GCP compliance and seeking a better understanding of FDA, inspections, regulatory actions and how they can improve their own firm's operations and monitoring of their state of GMP compliance
• Individuals who come in contact with regulatory inspectors
• Auditors
• Compliance/Regulatory affairs professionals
• QA/QC professionals
• Senior management executives (CEO, COO, CFO, etc.)
• Manufacturing managers, supervisors & personnel
• Project Managers
• Regulatory Affairs Management
• Regulatory Affairs Specialist
• Auditors
• Compliance Officer
• Compliance Specialist
• Clinical Affairs
• Quality Assurance Management
• Marketing & Sales
• Distributors/Authorized Representatives
• Legal Counsel
• Engineering/Technical Services
• Operations/Manufacturing
• Consultants

Course Outline:
Day 1:
Lecture 1: FDA History, Inspection Preparation, Handling and Closure
Lecture 2: Warning Letters
Lecture 3: Recap of Day 1
Day 2:
Lecture 4: Seizures
Lecture 5: Injunctions
Lecture 6: Prosecution
Lecture 7: Exercise and Recap of Day 2
Speaker Profile:
David R. Dills, Regulatory & Compliance Consultant with more than 24 years of hands-on experience and a proven track record within the FDA regulated industry, has an extensive regulatory and compliance background with Class I/II/III and IVD devices, pharmaceutical operations, and manages activities within the global regulatory and compliance space. He has been involved in many FDA and other regulatory inspections as well as part of multiple FDA remediation activities involving CIA's Consent Decrees, Seizures and other enforcement actions, including responding to Warning Letters. He manages quality, regulatory and compliance projects with multiple competing priorities having a direct impact on site operations and commercial opportunities and develops strategies for governmental approval to introduce new products to market, provides guidance on regulatory and compliance requirements and prepares/reviews worldwide submissions/dossiers/technical files and addresses global regulatory requirements. Background encompasses broad capabilities in quality systems, validation, regulatory affairs, compliance, auditing, interfacing with the regulatory agencies, addressing enforcement actions and mitigating compliance exposure for companies via remediation, compliance engineering support, post-marketing surveillance and vigilance reporting; clinical affairs, establish and/or remediate Quality Management and documentation systems for GxP compliance; preparation for ISO 13485 registration and CE Mark; and multi-country product registrations and licensing; and working with Notified Bodies, and AR's. David manages regulatory problems (e.g. AE's, MDRs, Agency enforcement, complaints/investigations, field alerts/recalls) related to development, manufacturing, and commercialization, and recommends action to senior leadership to ensure effective resolution for manufacturers to achieve sustainable and proven compliant systems. This is based on analyzing the benefits/risks for informed decision-making and interprets the regulatory precedents and new legislation. He strives to optimize business performance through proactive strategies to mitigate compliance exposure by providing strategic and tactical solutions that facilitate the achievement of regulatory and quality milestones. David has been previously affiliated with well-known device manufacturers and service providers, including a global CRO and has served in various quality, regulatory and compliance management and advisory capacities with increasing responsibilities. David is an industry speaker and author of technical and compliance related topics published in industry journals. Please refer to his profile provided herein for additional information about his background and areas of interest and focus.
Date, Venue and Price:
Location: Minneapolis
Date: June 5th & 6th 2014
Price: $1295.00
Discount: Register now and save $200. (Early Bird)
Until April 30, Early Bird Price: $1,295.00, From May 01 to June 03, Regular Price: $1,495.00
Contact Information:
John Robinson
Toll free: 1800 447 9407
Fax: 302 288 6884
Email: support@globalcompliancepanel.com
Website: https://www.globalcompliancepanel.com
Live Chat - Online Help Desk: http://www.globalcompliancepanel.com/chat/client.php
NetZealous LLC
161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA
For More Info on This Seminar Kindly Go through the Below Link:

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GlobalCompliancePanel Seminar Gallery: http://bit.ly/1mCjvMb

From: June 05, 2014 09:00
To: June 05, 2014 18:00

Minneapolis, Minneapolis, United States


Medical & Health Care, Pharmaceuticals/Drug Discovery


Compliance Training, ComplianceOnline, FDA Compliance, FDA Training, FDA inspections

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