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.
Who Will Benefit:
Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment
Recorded video session
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.