This seminar will guide the attendee in effectively handling, addressing and remediating FDA’s and other related compliance issues associated such as FDA’s Form 483, Warning Letter and Consent Decree Compliance Findings. An effective handling and resolution of Compliance issues will prevent further disciplinary actions such as an FDA’s Warning Letter or a formal Consent Decree which ends with a costly impact, fines and possible injunctions by the FDA. Because the impact of non-compliance and remediation of compliance issues are very costly, time consuming and impacting to a business and associated manufactured product including an increasing severity of disciplinary action by the FDA, understanding the triggers, effective preventative and corrective actions and an effective and expedient resolution of such compliance issues will assist a manufacturer of product in preventing expensive remediation of compliance issues, delays to product launch, impact on current commercially available product, overall business reputation, product recall, Fines, loss of impacted Product, loss of business licensure and/or prosecution by the FDA.
Understanding the various implications of not adhering to the rules and regulations of the specific requirements guiding each product types and observed mistakes made by some manufacturers of products that led to the closure of several manufacturing site through an FDA injunction and further bankruptcy of a cGMP product manufacturer will be discussed. This will help in preventing a similar mistake or further detrimental actions from happening or progressing into even more difficult ones. The difficulties and cost associated with remediating an FDA’s Consent decree is very high and most manufacturers of a cGMP drug product have found it very difficult to come out of a consent decree due to the difficulties associated with remediation. Preventing the initiation and progression of compliance related issues and then instituting an appropriate way to address these issues effectively and expeditiously before they become impacting will be discussed. This seminar enhance the attendees’ knowledge as follows:
- A description of what constitutes an FDA’s Form 483 Compliance Findings, Warning Letter or Consent Decree.
- The progression and severity of the various FDA compliance findings, triggers of the various progression of the compliance related disciplinary issues and criticality of each type.
- Discuss what companies are doing “Right” and “Wrong” when they have compliance related findings and letters such as FDA’s form 483 Findings, Warning Letter or Consent Decree.
- Discuss the reasons why some companies with recurrent unresolved FDA’s Form 483 findings end up with further progressive compliance issues such as a subsequent FDA’s Warning Letter and/or a Consent decree.
- Effective Steps in resolving FDA’s Form 483 Findings, Warning Letter and Consent Decree. The importance of expediting a company’s response to each type of compliance citation from by FDA.
- Discuss the entire process of Consent Decree and various scenarios and players in the process through remediation.
- Discuss several damaging effects arising from unresolved and difficult compliance related issues such as FDA’s Form 483 Compliance Findings, FDA’s Warning Letter and Consent Decree.
- The cost and other impact associated with resolving compliance Remediation Costs.
- The overall impact on manufactured products, regulatory filings, employees, product filing, and the overall business and its reputation.
- The most effective ways in addressing, handling and resolving or remediating compliance issues associated with FDA 483, Warning Letter and Consent Decree issues.
- Discuss several case studies of companies with progressive compliance issues that ended up in Consent Decree.
Guidelines: The criticality adhering to the requirements of the Code of Federal Regulations (CFR) and other associated guidelines and best practices cannot be over emphasized. The attendees will be provided a great resource in understanding the various stages of compliance issues and the resulting impact on the manufactured product and business.
Processes and Compliance Issues: A step by step process and description of the various levels of compliance issues and the progressive discipline issued by the FDA such as an FDA’s Form 483 Findings through Warning Letters and into a Consent Decree will be addressed. Discussions of what some companies are doing “Right” and “Not Right” in addressing and resolving compliance related issues and triggers of a severe action by the FDA will be discussed in detail.
Cost Effective Ways: Attendees will be able to understand the most effective and cost efficient ways in handling, resolving and/or preventing recurring future difficult compliance related, appropriate remediation process, timelines, overall cost implications associated with unresolved compliance issues.
Case Studies: Several case studies will be discussed on the progression that occurred with some companies that ended up in a Consent Decree situation and how their compliance issues would have been most effectively resolved will be discussed. Learning from past mistakes and preventing further compliance mistakes as observed by these companies with current Consent Decree will be discussed as case studies.
Who will Benefit:
The Seminar will benefit people within the pharmaceutical, biotechnology or medical device industries that currently have a stability testing program but are not savvy about maximizing the use of their data for extending their product’s expiration dating. The employees who will benefit most include:
- Quality Control Analyst and Management
- Senior Management
- Manufacturing Associates and Management
- Shipping and Distribution Personnel
- Stability Testing Department Personnel and Management
- Regulatory Affairs
- Quality Assurance Analyst and Management
- Process Design Personnel and Management
- Drug Packaging Personnel and Management