4 Training Courses on How to Manage FDA 483s and Warning Letters

When the FDA documents that a firm has significant deviations from applicable legal requirements, it will issue that firm a Warning Letter. As an enforcement tool, the FDA Warning Letter tells you that your firm is facing harsh enforcement action unless you correct the errors of your ways. What you say and, more importantly, what you do can make or break your future with the FDA. The Warning Letter is a regulatory spring board that leads you into treacherous waters. Currently, the FDA aggressively manages Warning Letters. The threat of further legal action is real. You have little, if any, breathing room for mistakes or oversights in your response. By effectively managing your Warning Letter response, you can avoid being a statistic for other legal actions, like seizure, injunction, prosecutions, fines and product detention.
Instructor: Angela Bazigos, Casper E Uldriks, Jerry Dalfors
Product ID: PACK70034

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Who will benefit?

  • CEO
  • IT VPs
  • Regulatory Affairs Professionals
  • Quality Assurance Managers
  • Small Business Owners
  • Senior Operations and Finance Executives
  • In-house Legal Counsel
  • FDA Consultants
  • Public Relations Professionals
  • Sales and Marketing Executives
  • Manufacturing Executives
  • Design Engineers
  • Third Party Consultants

Webinars included in the Package:

The Hitchhiker's Guide to 483s and Warning Letters (Duration: 120 Minutes)

Audits by the FDA are perhaps the most intimidating of all events at a regulated facility. Each year, the FDA conducts several thousand audits, approximately half of which lead to findings that result in Form 483s. Most Form 483 audits are amicably resolved, but a few lead to serious consequences for the audited parties, starting with Warning Letters and ending with heavy fines and jail time for a few. This webinar will assist you in responding to a 483 or Warning Letter so the consequences of the findings do not escalate beyond the current status.

Objectives of the Presentation:

  • FDA Inspections - background
  • Causes of Form 483 / Warning Letter
  • Some recent results of companies failing to respond appropriately
  • Best Practices for Responding to 483
  • Best Practices for Responding to Warning Letter
  • What to do if the responses fail

Instructor Profile:

Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc. "Knowledge is Power". She has 35 years of experience in the Lifesciences industry spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at speeding up Software Compliance.

Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA and RAPS. She works closely with the FDA on behalf of her clients. She consults to LifeScience Investment Groups as well as to Pharma / Biotech / Medical Device companies on compliance matters, including strategy, submissions, quality assurance and remediations following action by the FDA.

The Infamous Form FDA 483: How you respond can Make or Break you (Duration: 60 Minutes)

Prior to an inspection, the consumer safety officer (CSO) will review prior 483s issued to the establishment and the responses previously made by the firm concerning promised corrections. You will be held accountable for your prior response. What you promise and what you do, or don't do, become critical factors in the FDA's assessment of a firm's capacity to operate in compliance with the FDA's applicable requirements. A failure to establish and implement a corrective action to prevent prior deficiencies reflects poorly on the firm's management. The FDA will hold the firm's management accountable for its failure to adequately correct its regulatory problems. In some cases, the FDA will hold senior management personally liable for their managerial actions or inaction. Again, what a firm promises and what a firm does in response to a 483 makes a difference. It creates a body of proof that may set the basis for legal action by the FDA.

Objectives of the Presentation:

  • What the Form FDA 483 means
  • How to manage the FDA's 483 observations during and after an inspection
  • What the FDA considers important
  • How to respond effectively to 483 observations
  • Plan for the wake of problems generated by a 483
  • Learn how to restore, or destroy, your regulatory profile with the FDA

FDA Warning Letter Management (Duration: 60 Minutes)

The risk of receiving a Warning Letter should prompt you to develop a plan of action before the "bad news" is actually delivered. Once you receive a Warning Letter, you face short and rigid time deadlines, a credibility issue with the FDA and painful consequences in terms of time, money and reputation. An effective Warning Letter response can mitigate most of the inevitable damage. On a more positive note, a firm can develop and implement an impressive change in its regulatory program and apply it going forward to other areas. It happens.

Objectives of the Presentation:

  • Gauging the likelihood of receiving a Warning Letter
  • Preparing for a Warning Letter
  • Interpreting a Warning Letter as a micro and macro problem
  • How and when to respond a Warning Letter
  • Interacting with FDA staff
  • Immediate, intermediate and long term business impact
  • Warning Letter Post Mortem
  • Mapping your regulatory future

Instructor Profile:

Casper E Uldriks held a number of positions at FDA, such as an investigator in FDA's New England office, in the Office of the Commissioner in Legislative Affairs and in the Center for Devices and Radiological Health (CDRH), where he served as CDRH's Associate Director for Regulatory Guidance and Government Affairs. He helped to guide CDRH to develop and implement various medical device related amendments to the Food, Drug, and Cosmetic Act, regulations and guidance documents. For years he has trained FDA staff on medical law and has been a featured speaker at many professional conferences involving FDA's medical device program.

CAPA Training and Causes of Warning Letters due to Lack of Comprehension (Duration: 90 Minutes)

A timely, well documented, Corrective / Preventive Action program validates a quality system that is not only capable of identifying potential problems but also effectively correcting problems when incidents do occur and as part of the Continuous Quality Improvement program, correcting potential problems prior to occurrence. Adequate incident tracking is the primary foundational element for an effective CAPA system. Proper completion of the required forms in the "proper" order as described in the corporate directives and site procedures is what is required to remediate and prevent future observations by auditors and inspectors who have found numerous implementation issues and execution as result of variances in overall comprehension (failure to establish and maintain an adequate CAPA program).

Objectives of the Presentation:

  • CAPA
  • Identification of the incident
  • Evaluation of the impact or magnitude of the incident
  • Initiation and Risk Assessment
  • Investigation
  • Root Cause Analysis
  • Action Plan
  • Implementation Plan
  • Verification
  • Effectiveness monitoring plan
  • And moreā€¦

Instructor Profile:

Jerry Dalfors has extensive (40+ years) of business administration, consultative, technical and managerial experience in the development and manufacture of highly regulated biopharmaceutical products including injectables, biologics, medical devices and oral dosages. He has held permanent employee, temporary employee and company representative management positions with a multitude of the major pharmaceutical and biotechnology companies in the US.

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