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Best Practices for FDA 483 obs & Warning Letter Responses

August 15, 04.00 pm IST

BEST PRACTICES FOR FDA 483 OBS & WARNING LETTER RESPONSES

Educational Session by Daniel J. Roberts

About the Webinar

It is critical that an appropriate regulatory response is made to the Agency following a U.S. FDA inspection. There are strict deadlines to respond to the FDA 483 Observations and the Agency also has internal deadlines to meet to determine the classification of a facility following an inspection. Often times an adequate response can make the difference between an inspection being classified as Voluntary Action Indicated (VAI) acceptable status or Official Action Indicated (OAI) with recommendation for further action including warning letter, application withhold recommendation and import alert. The regulatory response should communicate in an efficient manner the nature of the observation made at the facility and discuss the corrections that were made during and following the inspection. The response to the Agency should be comprehensive and holistic in the approach to addressing the observation as well as provide evidence of corrections and timelines for completion for any pending corrections that may take additional time to complete. This webinar will discuss some best practices in an open forum for responding to Form FDA 483, Inspectional Observations, warning letter responses and other regulatory compliance queries.


Daniel J. Roberts, Senior Specialist Pharmaceutical and Biotechnology Practice, has over 19 years of government regulatory and pharmaceutical/biopharmaceutical industry experience. He was a United States FDA investigator for 8 years including 2 years overseas as the primary point of contact for conducting pharmaceutical inspections at the FDA India Office located at the United States Embassy in New Delhi, India.

As an investigator, Mr. Roberts conducted Pre-Approval Inspections (PAIs) and for-cause investigations and inspections of pharmaceutical manufacturers of human and veterinary sterile and non-sterile finished dosage forms and APIs worldwide. During his tenure at the Agency, he conducted over 100 pharmaceutical inspections as a lead investigator. Significant compliance actions including 24 Warning Letters and Untitled Letters as well as 5 Import Alerts were issued because of the inspections that Mr. Roberts has conducted. Mr. Roberts was also the lead investigator for the first biosimilar inspection conducted by FDA in India. Mr. Roberts has also graduated from the U.S. FDA Biotechnology Partnership training through North Carolina State University where upscale fermentation and bioreactor processes, as well as downstream purification processes, aseptic processing and quality control laboratories were covered. Prior to joining U.S. FDA, Mr. Roberts worked in the biopharmaceutical/biotechnology industry for 8 years specializing in quality control analysis for large molecule biotherapeutics. Mr. Roberts has also worked in scale-up bacterial and yeast fermentation process development to optimize parameters prior to handing over the process to the commercial production operations in a GMP facility.

As a Senior Specialist at Hogan Lovells, Mr. Roberts successfully guides domestic and international clients in the preparation for and management of successful U.S. FDA pre-approval inspections and systems based inspections. He evaluates and assesses pharmaceutical quality systems and specializes in detecting and remediating data integrity concerns and evaluating compliant automated manufacturing process and related computerized systems. He provides guidance and assists clients in responding to FDA-483 observations, correspondences with regulatory agencies, and mock U.S. FDA facility audits.

Mr. Roberts has a B.S. in Molecular Cellular and Developmental Biology from the University of California-Santa Cruz, California. Mr. Roberts is also an ISPE’s Pharma 4.0™ Special Interest Group (SIG) member for Holistic Control Strategy.