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Who should attend Effectively Addressing and Remediating FDA's Form 483 Findings, Warning Letters and Consent Decree Compliance Issues
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
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Seminar Summary:

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. (see full course description)

 
 
 

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Training Course Syllabus:


Effectively Addressing and Remediating FDA's Form 483 Findings, Warning Letters and Consent Decree Compliance Issues: 2-day In-person Seminar.

Course Description:

This seminar will guide the attendee in effectively handling, addressing and remediating FDAs and other related compliance issues associated such as FDAs 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 FDAs 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.

Learning Objectives:

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 FDAs 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 FDAs 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 FDAs form 483 Findings, Warning Letter or Consent Decree.
Discuss the reasons why some companies with recurrent unresolved FDAs Form 483 findings end up with further progressive compliance issues such as a subsequent FDAs Warning Letter and/or a Consent decree.
Effective Steps in resolving FDAs Form 483 Findings, Warning Letter and Consent Decree. The importance of expediting a companys 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 FDAs Form 483 Compliance Findings, FDAs 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.

Areas Covered:

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 FDAs 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.

Course Outline:
Day 1 (8:00 AM 5:00 PM)

8:00 9:00 am: Breakfast and Registration

9:00 am 9:30 am

Regulations Guiding the Manufacture of cGMP Products and/or Services

Understanding the Importance and Criticality of the Code of Federal Regulations (CFR) Guiding the Various Products, Industries and Processes
Description of the Various Parts of the CFR
Compliance Expectations, Requirements and Specific Roles of Manufacturers of Products Regarding Compliance.
Other National and International Regulations Guiding the Manufacture of Various Products and their Relationship and Importance.

Session 1

9:30 am 10:15 am

Topic: Types and Levels of FDAs Regulatory Findings and Disciplinary Actions Relating to Various Compliance Issues
Knowledge Base: Attendees will gain an understanding in the following key areas:
Summary of what constitutes an FDAs Form 483 Findings and the sequence of events that triggers its progression into the next stage of FDAs disciplinary action FDAs Warning Letter.
Summary of what constitutes an FDAs Warning Letter and the sequence of events that triggers its progression into the next stage of FDAs disciplinary action Issuance of a Consent Decree.
Understanding what an FDAs Consent Decree is and what triggers the initiation of a Consent Decree.
Detailed Understanding of an FDAs Form 483 Compliance Issue Findings
What triggers an FDAs Form 483 Compliance Issue Findings?

Session 2

10:15 am - 11:00 am

What Constitutes an Adequate response time to an FDAs Form 483 Compliance Issue Findings?
What Constitutes an Effective Handling and Response to an FDAs Form 483 Compliance Issue Findings?
How to Resolve an FDAs Form 483 Compliance Issue Findings?
What Some Companies are Doing Well in Effectively Addressing and Resolving an FDAs Form 483 Compliance Issue Findings?

11:00 am 11:15 am(Break)

Session 3

11:15 am - 12:00 pm

What Some Companies Not Doing So Well in Effectively Addressing and Resolving an FDAs Form 483 Compliance Issue Findings?
What Does a Recurring Non-compliance of an FDA Form 483 Compliance Issue Findings mean?
Impact and Next Disciplinary Actions if the Compliance Issue Findings are not effectively resolved by Companies.
How to Effectively Perform a Remediation of an FDAs Form 483 Compliance Issue Findings?
Remediation Activities Associated with FDAs Form 483 Compliance Issue Findings?
Preparing for Future FDA Visits and Audits after a Previous FDAs Warning Letter Compliance Issue Findings.

12:00 pm - 1:00 pm (Lunch Break)

Session 4

1:00 pm - 2:00 pm

Topic: Detailed Understanding of an FDAs Form 483 Findings-Compliance Issues

Knowledge Base: Attendees will gain an understanding in the following key areas:
What triggers an FDAs Warning Letter?
What Constitutes an Adequate response time to an FDAs Warning Letter
What Constitutes an Effective Handling and Response to an FDAs Warning Letter
How to Resolve an FDAs Warning Letter
What Some Companies are Doing Well in Effectively Addressing and Resolving an FDAs Warning Letter?
What Some Companies Not Doing So Well in Effectively Addressing and Resolving an FDAs Warning Letter.

Session 5

2:00 pm - 3:00 pm

What Does a Recurring Non-compliance of an FDA Warning Letter Compliance Issues mean?
Impact and Next Disciplinary Actions if FDAs Warning Letter Compliance Issues are not effectively resolved by Companies.
How to Effectively Remediate an FDAs Warning Letter
Remediation Activities Associated an FDAs Warning Letter Compliance Issue?
Preparing for Future FDA Visits and Audits after a Resolution of a Previous FDAs Warning Letter FDAs Form 483 Compliance Issue?

3:00 pm - 3:15 pm (Break)

3:15 pm - 4:00 pm(Review of Case Studies)

Review of Case Studies on Pharmaceutical Stability Testing - FDAs Warning Letters to Companies: Issues Encountered by Drug Product Manufacturers Based on Failure to Address Compliance Issues, Recurring Form 483 Compliance Issues, Warning Letters and Consent Decree:

Case Study Category #1 (Companies with Recurring FDAs Form 483 Compliance Issues):

Discussion of several Case Studies relating to companies with a recurring FDAs Form 483 compliance findings and triggered Warning Letter issuance.
What was not done Right in addressing the compliance related issues based on the FDAs Form 483 Findings?
Effective ways and approach to resolution that was not applied. Best practices that these companies would have applied that would have prevented the progressive discipline by the FDA into the issuance of an FDAs Warning Letter.
Examples will be discussed and an interactive session on this case study will be applied.

Case Study Category #2 (Companies with an Issued FDAs Warning Letter)

Discussion of several Case Studies relating to companies with an FDAs Warning Letter and what triggered the issuance of the FDAs Warning Letter.
What was not done Right in addressing the compliance related issues based on the FDAs Warning Letter?
Effective ways and approach to resolution of the Warning Letter that was not applied.
Best practices that these companies would have applied that would have prevented the progressive discipline by the FDA into a Consent Decree.
Examples will be discussed and an interactive session on this case study will be applied.

4:00 pm - 5:00 pm (Questions and Answer Session)

5:00 pm (Close of Seminar)

Day 2 (8:00 AM 5:00 PM)

8:00 9:00 am: Breakfast and Registration

9:00 am 9:30 am

Regulations Guiding the Manufacture of cGMP Products and/or Services

Understanding the Importance and Criticality of the Code of Federal Regulations (CFR) Guiding the Various Products, Industries and Processes
Description of the Various Parts of the CFR
Compliance Expectations, Requirements and Specific Roles of Manufacturers of Products Regarding Compliance.
Other National and International Regulations Guiding the Manufacture of Various Products and their Relationship and Importance.

Session 1

9:30 am 10:15 am

Topic: Effectively Handling, Resolving and Remediating an FDA Issued Consent Decree
Knowledge Base: The Attendees will gain an understanding in the following key areas:
What triggers an FDAs Consent Decree?
Steps that may lead to the issuance of an FDAs Consent Decree
What Constitutes an Effective Handling and Response to an FDAs Consent Decree?
How to Resolve an FDAs Consent Decree Compliance issues
What Some Companies are Doing Well in Effectively Addressing and Resolving an FDAs Consent Decree Compliance issues.

Session 2

10:15 am - 11:00 am

What Some Companies Not Doing So Well in Effectively Addressing and Resolving an FDAs Consent Decree Compliance issues.
Impact and Next Disciplinary Actions if FDAs Consent Decree Compliance issues are not effectively resolved by Companies.
How to Effectively Remediate an FDAs Consent Decree Compliance issues.
Remediation Activities Associated an FDAs Consent Decree Compliance issues.
FDA Consent Decree and Third Party Consulting Companies
Role of FDA Approved Third Party
Role of the Companys Executives and Employees
Outside Consultants and Costs

11:00 am 11:15 am(Break)

Session 3

11:15 am - 12:00 pm

Commitments and Timelines Associated with an issued Consent Decree Agreement
What is known as Commitments and understanding the Criticality of Consent Decree Commitments
Timelines Associated with Consent Decree
Fines Associated with Consent Decree Timelines
Impact of a Consent Decree on a Business
Costs Associated with a Consent Decree
Impact to Personnel Within the Company
Impact to the Company
Impact to all Manufactured and New Products
Possible Facility Closure
Possible Business Bankruptcy
Possible FDA Injunction
Possible Debarment-Who may be affected?
Product Recall and Investigations
Gaining back Reputation after a Consent Decree Compliance Related Issues
Preparing for Future FDA Visits and Audits after a Previously Issued Consent Decree.

12:00 pm - 1:00 pm (Lunch Break)

Session 4

1:00 pm - 2:00 pm

Topic: Damaging Effects, Associated Impact and Preventative Measures Associated with FDAs Form 483, Warning Letter and Consent Decree Compliance Issues
Knowledge Base: Attendees will gain an understanding in the following key areas:
Impact of a Compliance Issues on a Manufactured Product and Business
Costs Associated with Compliance Issues
Impact on Personnel Within the Company
Impact on the Business or Companys Bottom Line
Impact to all New and Existing Manufactured Products
Possible Facility Closure
Possible Business Bankruptcy
Possible FDA Injunction
Possible Debarment-Who may be affected?
Product Recall and Investigations

Session 5

2:00 pm - 3:00 pm

Case Study Category #3 (Companies with an Issued Consent Decree)

Discussion of several Case Studies relating to companies with FDAs Consent Decree and triggered issuance of the Consent Decree.
What was not done Right in addressing the compliance issues based on the FDAs Findings?
Effective ways and approach to resolution that were not applied to prevent a Consent Decree.
Best practices that these companies would have applied that would have prevented the progressive discipline by the FDA.
Examples will be discussed and an interactive session on this case study will be applied.

3:00 pm - 4:00 pm (Open Questions and Answer Session)

4:00 pm - 5:00 pm (Closing Comments and Adjournment)

Seminar Summary:

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. (see full course description)

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