Winning Strategies for Successful US FDA Inspections: Conducting an Effective Mock Pre-Approval Inspection & Implementing Robust Remedial Measures


Instructor: Nada Kuganathan
Product ID: 705925

  • Duration: 90 Min
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.
Last Recorded Date: Feb-2019


$219.00 $279.00 (21%)SAVE: $60.00
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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
Instructor Profile:
Nada Kuganathan

Nada Kuganathan
President and Principal Consultant, Enkay Consulting Services Inc

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, 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 global 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.

Nada holds a Master of Science degree from University of London, England. He served in the Board of Directors of Pharmaceutical Sciences Group (PSG) of Canada from 1998 to 2000. He was the chair of the Seminar Committee of PSG, Canada in 2000. He also served as a working group member (2011-2012) for defining “Auditor Qualification” for Rx 360, an international pharmaceutical supply consortium.

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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).




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