Overview of GXP Compliance and FDA Trends in 2019

Explore the circumstances that impact the quality, safety, and availability of drugs and gain new perspectives and discuss best practices on the evolving regulatory landscape, supply chain risks, quality culture, and challenges in manufacturing:

  • Latest FDA inspection findings;
  • Compliance/enforcement trends;
  • Quality trending;
  • Effective quality systems;
  • Consent decree lessons learned).

A wonderful opportunity to share some of our experiences as professionals working in biopharma and regulatory affairs.

Objective of Workshop

To provide over view  of the GXP and its importance in Life Science /Pharma industry.

Proposed topics in the workshop

  • Overview of the GXP compliance and Regulatory issues and Current FDA observations on Pharma Industry.
  • Drug Development and Regulatory Strategy (NDA and ANDA) and prepare the companies for Pre Approval Inspections.

Presenters


DR. Kris Venkat

Extensive experience in the development and manufacturing of pharmaceuticals, recombinant proteins and vaccines. Held senior level positions at J&J, Covance, GSK, BMS and Pfizer.

Contributed to the development of anti -T3, anti-CD20, anti-RSV, anti-IL 4 and IL-5, Orencia, Eribitux, Mylotarg and Prevnor-13. Provided consulting services to India based companies on the development of generic cancer drugs and Biosimilars. Provided consulting services to the US and Europe based biologics and pharma companies on data integrity remediation, analytical methods validation, process development and validation, warehouse operations and consent decree/warning letters remediation activities. Performed CRO/CMO audits and provided regulatory strategy on CMC changes to US, Europe and India based companies. Currently providing consulting services to US-based companies on preclinical development, GLP/GMP training, data integrity assessment and remediation of FDA observations.

Dr. Kenneth E Cleaver

Supply expertise in Quality Assurance, Clinical Research and Regulatory Affairs to assist in quality systems improvements, product development, and marketing approval of medical products. Experienced in all aspects of quality management for pharmaceuticals, medical devices, and biologicals. Expertise includes GLP, cGMP, GCP, ISO-10971, ISO-13485 and ISO-9000 regulations as they apply to Quality Systems. Activities include Quality System design and revisions, audits, training and Expert Witness reviews.

Managed Quality Assurance of laboratory services, including GLP and cGMP compliance. Supervised the IND development, analytical testing, contract manufacturing, clinical trials and licensing of an FDA-approved orphan drug for premature infants. Developed client confidence, resulting in a 30% growth in staff and new contracts.

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Date: August 8, 2019

Time: 10.30 am to 12.30 pm EST