Register for FDA Seminar on “Avoiding Inspections Leading to Warning Letters, Seizures and Injunctions”
July 10 - 11, 2014 - Boston CA USGlobalCompliancePanel
support@globalcompliancepanel.com
Phone:8004479407
Fax:302-288-6884
Overview: 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. 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 Instructor/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. Date, Venue and Price: Location: Boston Date: July 10th & 11th 2014 Venue: Courtyard Boston Logan Airport Address: 225 William F. McClellan Highway - Boston, Massachusetts 02128 USA Price: $1295.00 Discount: Register now and save $200. (Early Bird) Until June 16, Early Bird Price: $1,295.00, From June 17 to July 08, Regular Price: $1,495.00 Contact Information: Event Coordinator Toll free: 1800 447 9407 Fax: 302 288 6884 Email: support@globalcompliancepanel.com Website: https://www.globalcompliancepanel.com LIVE CHAT SUPPORT ALSO - http://www.globalcompliancepanel.com/chat/client.php GlobalCompliancePanel NetZealous LLC 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA For More Info Click Here: http://bit.ly/FDAandAvoidingInspections To Download Seminar Boucher: http://bit.ly/CombinationProductApproval GlobalCompliancePanel Seminar Gallery: http://bit.ly/1mCjvMb