ComplianceOnline

Development and Validation of Stability Indicating Methods-Planning-Design-Conduct-Documentation

Instructor: Dr. Ludwig Huber
Product ID: 701002
  • Duration: 90 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$500.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

Email: customercare@complianceonline.com

Read Frequently Asked Questions

In this FDA compliance training learn regulatory expectations for stability indicating methods & Purpose and requirements for stability indicating methods.

Description

There is a lot of concern related to the stability of various drugs over different periods of time and different companies are following different approaches to this problem.

Why Should you Attend:

Stability indicating methods are quantitative test methods that can detect changes with time of drug substances and drug products. Information of type and amount of degradation products over time is important for safety of drugs. Therefore, FDA and other agencies but also good business practice requires such methods to be well designed and validated.

Areas Covered in the seminar:

  • Regulatory expectations for stability indicating methods.
  • FDA Warning Letters and how to avoid them.
  • Business and compliance reasons for stability methods.
  • Purpose and requirements for stability indicating methods.
  • Planning for development.
  • Design meaningful stress conditions.
  • Procedures and measurement of forced degradation.
  • Special storage conditions.
  • Strategies for validation.
  • Staged validation approach during development.
  • Validation experiments.
  • Practical hints for validation experiments.
  • Documentation for FDA/EU GMP compliance.

For easy implementation, Attendees will receive:

  • Copies of all slides
  • SOPs
    • Validation of Stability Indicating Methods.
    • Validation of Analytical Methods.
  • Checklist:
    • Validation of Stability Indicating Methods.
  • Forms/Template
    • Documentation Validation Summary.
    • Planning template.
  • Reference Paper:
    • Validation of Analytical Methods: Review and Strategy.

Note: These complimentary hand-outs will be sent to customers on request. Please email customercare@complianceonline.com for these documents, stating your order number, and they will be emailed to you within 4 working days.

Who will benefit:

  • QA managers and personnel
  • Analysts and lab managers
  • Managers and staff of stability testing labs
  • Validation specialists
  • Training departments
  • Documentation department
  • Consultants
  • GMP/GCP auditors
  • Teachers

Instructor Profile:

Ludwig Huber,, is Compliance Program Manager at Agilent Technologies. He is the editor of www.labcompliance.com, the global on-line resources for validation and compliance issues for laboratories. He is the author of the books Validation and Qualification in Analytical Laboratories, and "Validation of Computerized Analytical and Networked Systems", Interpharm Press. He is also the author of the Macro & Spreadsheet Quality Package from Labcompliance. For more information, visit Dr. Huber’s website: www.ludwig-huber.com .

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