Analytical Procedures and Method Validation for Drugs and Biologics

Duration: 120 Minutes
In July 2015, the FDA published an updated guidance on Analytical Procedures and Methods Validation, replacing the 2000 draft guidance with similar title and the 1987 Guidelines for Submitting Samples and Analytical Data for Methods Validation. This recent guidance represents the current thinking of the FDA on this topic. It provides recommendations on how an applicant can submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products. It will help you assemble information and present data to support analytical methodologies. The recommendations presented in the guidance document apply to drug substances and drug products covered in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and supplements to these applications. The principles in this guidance also apply to drug substances and drug products covered in Type II drug master files (DMFs).
FDA Updated Guidance
Instructor: Angela K. Dunston
Product ID: 501322
Objectives of the Presentation
  • Be familiar with the new guidance and its scope
  • Understand expectations for method development, including robustness and risk assessment
  • Be familiar with expectations for contents of procedures and reporting of data
  • Be familiar with expectations for validation of compendial and noncompendial methods
  • Understand life cycle management of procedures, including when to revalidate or use method comparability testing
Why should you Attend
It is required of regulatory agencies that Analytical Procedures be provided with NDAs, ANDAs, BLAs and Supplements. A thorough understanding of the current thinking of what regulatory agencies consider to be appropriate as supporting documentation will help with the approval process and prevent unnecessary delays.

Areas Covered
  • Introduction
  • Background
  • Analytical Methods Development
  • Content of Analytical Procedures
  • Reference Standards and Materials
  • Analytical Method Validation
  • Statistical Analysis and Models
  • Life Cycle Management of Analytical Procedures
  • FDA Methods Verification
Who can Benefit
  • Senior Management
  • Regulatory Affairs Management and Personnel
  • Compliance Officer and Personnel
  • Quality Assurance Management and Personnel
  • Research and Development
  • Validation
  • Auditing Management and Professional
  • Quality Control Management and Professional
  • Contract Manufacturing and Contract Testing Facilities
  • Chemist
  • Scientist
Topic Background
Regulatory agencies require that analytical procedures are included with applications to ensure the identity, strength, quality, purity, and potency of the drug substance and drug product. Data must be available to establish that the analytical procedures used in testing meet proper standards of accuracy, sensitivity, specificity, and reproducibility and are suitable for their intended purpose.
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Instructor Profile:
Angela K. Dunston has over 20 years of experience in manufacturing and laboratory quality and compliance in the pharmaceutical, biotechnology, and medical device (diagnostics) industries. Her expertise is in defining, implementing, and maintaining Quality Management Systems that are cohesive and properly interact with all areas of the organization.

During these 20 years, Angela has actively participated in global regulatory inspections to include US FDA in the capacity of host, SME, and scribe. Through consulting with a variety of companies, Angela has worked with US FDA agents to ensure compliance for her clients.

The international experience obtained has assisted global organizations such as Johnson and Johnson, the Croda Corporation, Novartis, Hospira, Sanofi Pasteur, and Quintiles to exceed regulatory expectations. She has authored company best practices manuals and has trained on those procedures from the V-suite to the manufacturing floor. Angela works closely with the company’s staff to ensure a cohesive transition for non-compliance to policy approval.
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