Conducting an Effective Mock Pre-Approval Inspection (PAI) and Implementing Robust Remedial Measures for Successful US FDA Inspections

Nada Kuganathan

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In this FDA inspection webinar attendees will learn the proactive strategies and robust due diligence mock audits during pre-submission and post submission periods prior to FDA’s pre approval inspection to mitigate the potential compliance risk identified during the mock pre approval inspection in a proactive manner.

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”.
  • Current FDA’s thinking on cGMP concerns & Warning Letters.
  • How to recommend effective, pragmatic remedial measures for the noted findings to mitigate potential compliance risk for successful FDA’s PAI inspections.
  • “Audits are meaningless if CAPA are not successfully implemented”- A key take home message.
  • Ideal course for learning opportunities for auditors

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
  • Legal Staff

Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Nada Kuganathan, President and Principal Consultant, Enkay Consulting Se

Nada Kuganathan is a seasoned Quality and Compliance professional with extensive experience & knowledge and proven track record for more than 30 years in the pharmaceutical industry. This experience included branded, generic, contract and consulting business environment in QA, QC, Compliance, Validation, and Training in the global arena with good understanding of cultural differences.

Nada is currently the president & principal consultant of “Enkay Consulting Services Inc.”, CA, and USA. In this capacity, Nada has successfully completed several consulting activities with large, medium and start-up pharmaceutical companies related to Quality, Compliance, Microbiology and Training areas. This not only included Vendor Qualification, strategic cGMP Gap Analysis, Mock PAIs, Due Diligence audits, but also to support pragmatic and robust implementation of remedial measures, Site preparation for US FDA compliance & remedial measures for 483s and warning letters in the globe arena. His work involves a variety of dosage forms of drugs, combination products (both sterile and non-sterile), OTC and dietary supplements.

Prior to consulting, Nada served as Executive Director, Global Compliance with Actavis (Formerly Watson and now Allergan). Nada held management positions in quality, compliance, microbiology and technical projects with increasing responsibilities in pharmaceutical industry with hands on experience. During this period, he had conducted numerous strategic quality compliance audits in the lead capacity which included Mock PAI, cGMP gap analysis, corporate internal audits, and project implementation, vendor/supplier audits such as API, cell bank, excipient, contract manufacturing, laboratories, R&D facilities, and distribution centers for small and large molecule drug products around the world. This also included due diligence audits for product and company acquisition.

Nada had delivered several presentations to pharmaceutical industry professionals on QA, Compliance, Auditing & Vendor Qualification, Validation and Microbiology/aseptic topics via professional training organizations such as PDA, ISPE, IVT, CBI, SWE, PSG and other in the US, Canada, Europe and India.

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