Establishing an Effective & Pragmatic Vendor Qualification Program for cGMP Compliance in the Pharmaceutical Industry

Nada Kuganathan Instructor:
Nada Kuganathan 
90 Minutes
Webinar ID: 500804

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Price Details
Recorded Webinar
$199 One Attendee
$399 Corporate Recorded

Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)

Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)


This webinar will benefit all pharmaceutical & biotech professionals who work in QA, Compliance, Regulatory Affairs, Purchasing, and Supply Chain. This seminar will cover the importance of vendor qualification programs, and how well these programs can be implemented in a pragmatic & compliant manner.

This program will capture key aspects of the process from selection, monitoring, and taking remedial measures as necessary with the support of cross-functional groups within the organization from a small company to a multi-national corporation perspective.

Suggestions for cost-effective and pragmatic solutions will be discussed based on different scenarios. This will include applying risk management principles with a strong emphasis on risk mitigation efforts to sustain regulatory compliance and enhance the growth of the business.

Various types of audits, and how they can be implemented in a cost-effective manner will be discussed. Emphasis will be on the application of quality metrics using trending of various data.

The effective communication process of vendor-related quality & compliance metrics to cross-functional management groups to have a proactive approach will be also discussed. The aim is to find the root cause of the problem and correct the issue to prevent such recurrences in the future.

We will provide adequate opportunities to have your questions answered during the webinar.

Why should you Attend:
As stated in the "background" above, it is obvious that a vendor is considered an extension of your own operation. Hence their performance cannot be ignored. If they fail, companies using their products/services will also fail. Therefore, scrutiny of their business and regulatory compliance based on risk is of paramount importance. Implementation of a pragmatic, cost-effective, and robust audit program is vital for vendor qualification programs. Onsite audit performance is strongly suggested in applying risk management concepts in the vendor qualification program on a continuous basis. As a risk mitigation strategy, qualified backup suppliers should be readily available for usage.

It should be noted that if a component (from a qualified supplier) is not available from the vendor, there will not be a product by the manufacturing company. This will have a significant impact on the company’s business overall. Hence strong partnership with the vendors is important. In conclusion, a proactive approach with a bilateral communication process with the vendors in a healthy environment is vital for the success of the companies from a business and regulatory perspective.

Areas Covered in the Session:

  • Introduction
  • Outline the agenda
  • Presentation (Introduction, Main topics & Discussion & Summary Conclusion)
  • Question & Answer Session

Who Will Benefit:
  • Quality
  • Compliance
  • Purchasing
  • Supply Chain
  • Manufacturing & Business Development (Specialists, Supervisors, Managers & Senior Managers in those areas)

Speaker Profile
Nada Kuganathan Nada Kuganathan is a seasoned Quality and Compliance professional with extensive experience, knowledge, and a proven track record for more than 30 years in the pharmaceutical industry in the global arena. This experience included branded, generic, contract and consulting business environment in QA, QC, Compliance, Vendor Qualification, and Training. 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, Vendor Qualification & Supplier Audits, Training and US FDA Inspection Readiness. His work involves a variety of dosage forms of drugs, combination products (both sterile and non-sterile), biologics, and OTC.

Prior to consulting, Nada served as Executive Director, Global Compliance with Actavis (Formerly Watson and now Abbvie). During his career in management positions in QA and Compliance areas, he had conducted numerous strategic quality compliance audits in the lead capacity which included numerous supplier/contractor audits such as API, cell banks, excipient, contract manufacturing, laboratories, R&D facilities, and distribution centers for small and large molecule pharmaceutical products around the world. This also included due diligence audits for product and company acquisition. Nada has actively participated in leadership roles in successful strategic vendor qualification projects at a global level.

He was a member of the board of directors & chair of the evening seminar committee of Pharmaceutical Sciences Group of Canada (1999-2001) and a working group member of the auditor qualification team for Rx 360, an international pharmaceutical supply chain consortium (2011-2012). Nada has delivered numerous onsite presentations to pharmaceutical and API industry professionals on QA, Compliance, Vendor Qualification, Mock PAI, Auditing, Validation and Microbiology/Aseptic topics via leading professional organizations such as PDA, ISPE, IVT, CBI, SWE, PSG & other in the US, Canada, Europe, and India.

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