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An Extractable and Leachable Study Overview - by Jason Creasey
This presentation covers:
An Update on Guidance Around E&L
  • Current status of PQRI recommendations
  • Update on revisions and plans for USP chapters (including USP<665> and <1665>)
  • Biopharma Operation Group (BPOG) protocol updates
  • Update on ICH planning for an E&L chapter (ICH Q3E)
  • How E&L data leads to a successful product launch and protects patient safety
An Extractable and Leachable Study Overview - by Dr. Vandana Singh
This presentation covers:
  • ICHQ3D- Industry Perspective
  • Delaminativon- Concerns & screening Methods
  • Leachable in Pharmaceuticals
  • Important Application points & Troubleshooting's
Accelerating Extractable and Leachable Analytical study for better consumer health – by Dr. Venkat Manohar
This presentation covers:
  • Design strategy on Extractable and leachable studies
  • Selection of right conditions for extraction
  • Right analytical technique for target compounds
  • Setting up of best leachable study guidance
  • Profiling of known and unknowns
  • Ways for unknown material study
Extractable Leachable Correlations For Secondary Packaging Materials And Way Forward – by Dr. Srinivasarao Vaddadi
This presentation covers:
Chapters<661> , <661.1> ,<661.2> , <1661> and for Plastic Packaging Systems and Their Materials of Construction. A Status and Implementation Update.
Chapters<665> and <1665> for Polymeric Materials, Components and Systems used in the Manufacturing of Pharmaceutical and Biopharmaceutical Drug Products. Discussion of Contents and Changes.
Common Problems in Toxicological Risk Assessments Submitted to Regulatory Agencies and How to Avoid Them – by Ron Brown
This presentation covers:
  • Best practices for the preparation of a toxicological risk assessment of E&L compounds.
  • The common problems seen in risk assessments included in regulatory submissions and provide practical tips on how to avoid them.
  • Techniques that will help to prepare a risk assessment that will not result in a deficiency letter from the US FDA or other regulatory agencies
Evaluation of Extractables & Leachables in Parenteral Drug Products: Analytical Challenges & Case Studies – Dr. Md Yakub Iqbal
  • Drug Products & Packaging Concerns
  • Extractables Testing Workflow
  • Leachables Testing Workflow
  • Safety Thresholds for E&L Studies
  • Analytical Techniques for E&L Studies
  • Workflow for Screening & identification of Extractables &Leachables
  • Examples & Case Studies
  • Extractables &Leachables: Mitigation Strategies
Extractables & Leachables (E&L):Regulatory Perspective for Vaccines & Biological Product - Parag Nagarkar
Extractable Study Strategy: Risk Identification and E&L Study Strategy for Human Vaccine – By Dr. K.S. Jaganathan
This presentation includes:
  • Regulatory Requirements for E&L
  • Why, When and What to do E&L?
  • E&L risk assessment - Strategy?
Future of Extractable and Leachable testing? – by Jason Creasey
This presentation covers:
  • Discussion on the testing E&L quality & safety through improvements in the technology used
  • Requirements for extractable and leachable studies in biologics & vaccines
  • Potential Futuristic regulatory approaches
Modular and Risk Based Approach Towards Generation of Leachables Data to Support Regulatory Filings – by Dr. Karthik Ramani, Ph.D.
This presentation includes:
  • Regulatory framework
  • Risk Assessment-process and toxicological
  • Considerations and study design

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