In this Webinar, attendees will learn the winning strategies for successful FDA inspections and as how to conduct robust mock audits during pre-submission and post submission stages of drug product applications. This webinar will also include strategic approaches to implement robust remedial measures to mitigate the potential quality and compliance risks identified during the mock pre-approval inspection in a proactive manner.
The objective of this course is to teach the participants as to how effectively and strategically to target successful US FDA inspections.
Strategy for forming a cross functional robust audit team.
Key aspects of Development, Tech. transfer, Exhibit Batches, Submission of Application & FDA Correspondence.
Review of the CMC (Quality) section of the application & understanding of the big picture.
Strategic Pre-Onsite Audit Preparation- Gather key documents & How to identify strengths & Weaknesses of cGMPs & Product Quality.
On-site Audit Process, evaluate application commitment Vs Site findings and evaluate impact & potential risk.
How to utilize the time effectively during facility tour? Seeing is believing. Do not miss this golden opportunity to identify some critical issues during auditing.
Key focus areas for the audit & how to tackle those issues with time constraints.
Focus on change control, deviations, investigations, CAPA effectiveness & risk management process.
How to write an effective and meaningful audit report to communicate the message to management, loud and clear? Emphasis on “report is for the reader, and not for the author”.
FDA’s current thinking on Data Integrity issues, cGMP concerns, and Warning Letters.
How to recommend effective and pragmatic remedial measures for the noted findings to mitigate potential quality and compliance risks for successful FDA’s PAI inspections.
“Audits are meaningless, if CAPAs are not successfully implemented”- A key take home message.
Ideal course for learning opportunities for auditors and auditees.
Why Should You Attend:
Do It Right the first Time (DIRFT) is the challenge to many pharmaceutical companies to get the approval for their drug application from US FDA within the target timeframe for commercial marketing. If the companies failed to get the approval from regulatory agencies to meet their committed timeframe, it may have a significant impact on their business and regulatory areas for both private and public companies.The objective of this course is to teach the participants as to how effectively and strategically to target successful US FDA inspections.
Learning Objectives:
FDA’s Pre-Approval Inspection Program & Why Mock PAI?Strategy for forming a cross functional robust audit team.
Key aspects of Development, Tech. transfer, Exhibit Batches, Submission of Application & FDA Correspondence.
Review of the CMC (Quality) section of the application & understanding of the big picture.
Strategic Pre-Onsite Audit Preparation- Gather key documents & How to identify strengths & Weaknesses of cGMPs & Product Quality.
On-site Audit Process, evaluate application commitment Vs Site findings and evaluate impact & potential risk.
How to utilize the time effectively during facility tour? Seeing is believing. Do not miss this golden opportunity to identify some critical issues during auditing.
Key focus areas for the audit & how to tackle those issues with time constraints.
Focus on change control, deviations, investigations, CAPA effectiveness & risk management process.
How to write an effective and meaningful audit report to communicate the message to management, loud and clear? Emphasis on “report is for the reader, and not for the author”.
FDA’s current thinking on Data Integrity issues, cGMP concerns, and Warning Letters.
How to recommend effective and pragmatic remedial measures for the noted findings to mitigate potential quality and compliance risks for successful FDA’s PAI inspections.
“Audits are meaningless, if CAPAs are not successfully implemented”- A key take home message.
Ideal course for learning opportunities for auditors and auditees.
Who Will Benefit:
- Quality Compliance Auditors
- Compliance Staff
- R&D Staff
- Pharm Tech Staff
- Regulatory Affairs Staff
- Project Managers
- SMEs from Quality, Laboratory, Engineering, Production & Supply Chain
- Management from cross functional team
Speaker
Nada KuganathanCourse Provider
Nada Kuganathan,
