Qualification of the Dissolution Apparatus


Instructor: Gregory Martin
Product ID: 705342

  • Duration: 90 Min
This webinar will focus on the USP and FDA requirements for qualification of the dissolution apparatus including guidelines for USP Performance Verification Test and FDA Advanced Mechanical Calibration. It will also provide an overview of USP General Chapters <1058> and <711>.
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Why Should You Attend:

This webinar covers options available for qualification of the dissolution apparatus, how to perform the tests and how to develop a plan for successful qualification that will withstand regulatory inspections.

Upon completion of this course the learner should:

  • Be familiar with the rationale for instrument qualification, and the options available for USP Apparatus 1 and 2
  • Be familiar with the requirements and performance of USP Performance Verification Test and FDA Enhanced Mechanical Calibration
  • Understand some of the pitfalls associated with dissolution apparatus qualification
  • Be prepared to develop a laboratory policy for qualification of the dissolution apparatus

Areas Covered in the Webinar:

  • Basis for Qualification
    • Calibration and qualification of equipment requirements in GMP guidelines for FDA and EMA
    • USP General Chapter <1058> Analytical Instrument Qualification
    • USP General Chapter <711> Dissolution refers to Performance Verification Test
  • Approaches to Dissolution Instrument Qualification
    • Why is it challenging?
    • USP performance verification test tablets allow holistic evaluation of apparatus
    • FDA Enhanced Mechanical Calibration
  • USP Performance Verification Test
  • FDA Advanced Mechanical Calibration
  • Comparison of Mechanical Requirements: USP vs FDA
  • Common Pitfalls in Qualifying Dissolution Apparatus
  • Recommendations: Plan Ahead; Train; Anticipate Failures

Who Will Benefit:

  • Quality Control Personnel
  • R&D Scientists
  • Metrologists
  • Laboratory Supervisors and Managers
  • Quality Assurance Personnel
  • Chemists/Managers
  • Regulatory Affairs Personnel
Instructor Profile:
Gregory Martin

Gregory Martin
Founder and President, Complectors Consulting LLC.

Gregory Martin is President of Complectors Consulting (www.complectors.com), which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years’ experience in the pharmaceutical industry, including Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company to solving challenging problems. He provides consulting services to over 50 companies, including human and veterinary pharmaceutical companies, manufacturers of OTC and nutritional supplement products, and contract organizations.

In addition, he has volunteered for the USP for over 10 years, and currently serves on the General Chapters – Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules. He also serves on the Steering Committee of the AAPS IN Vitro Release and Dissolution Testing Focus Group.

He has particular interest in QbD/Lean approaches to dissolution testing, method lifecycle (development/validation/transfer), impurity testing and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin is has presented at several scientific meetings, and authored of several papers in the areas of dissolution and analytical method validation.

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