ComplianceOnline

Full-day Virtual Seminar: Addressing Impurities in Pharmaceutical Products

Instructor: Gregory Martin
Product ID: 702374
  • Duration: 7 hrs

Training CD

$899.00
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

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Read Frequently Asked Questions

This 7-hr webinar on Impurities in Pharmaceutical Products will provide a comprehensive overview of impurities which must be controlled in pharmaceutical products and the strategies for controlling them.

Course "Full-day Virtual Seminar: Addressing Impurities in Pharmaceutical Products" has been pre-approved by RAPS as eligible for up to 7 RAC credits towards a participant's RAC recertification upon full completion.

Why Should You Attend:

This webinar is designed to provide a comprehensive overview of impurities which must be controlled in pharmaceutical products, detailed review of the guidance documents related to each of the categories of impurities and strategies to address each, including reporting of test results. Topics for discussion include general impurities (not structurally related to the drug substance), such as residual solvents, elemental impurities, and microbial issues, and drug-related impurities, including process impurities, normal degradation products and potential genotoxic impurities.

Interaction and questions from the participants are actively encouraged throughout, and there will be ample time for questions at the end of the presentation.

Learning Objectives:

Upon completion of this course the learner should be able to:

  • Identify the various categories of impurities likely to be present in pharmaceutical products.
  • Be familiar with the guidance documents related to the various categories, and have an understanding of the requirements included in each.
  • Develop a strategy for addressing each of the categories of impurities, if appropriate for the particular dosage form.
  • Report the results of testing consistent with expectations of regulatory agencies.

Agenda (All time in EDT):

10:00 - 10:30

Overview of Impurities in Pharmaceutical Products Requiring Control

10:30 - 12:30

General Impurities

 

Residual Solvents

 

Elemental Impurities

 

Microbiological and Endotoxins Tests

12:30 - 1:30

Lunch

1:30 - 3:30

Drug Related Impurities

 

Process Impurities

 

Degradation Products

 

Potential Genotoxic Impurities

3:30 - 3:45

Break

3:45 - 4:45

Strategies for Control of Impurities

4:45 - 5:00

Questions

Areas Covered:

1. Overview of Impurities in Pharmaceutical Products Requiring Control

  • Residual Solvents (USP <467>)
  • Elemental Impurities (USP <231, 232, 233>)
  • Microbiological and Endotoxin Tests (USP <61, 62, 71 and 85>
  • Drug Substance Impurities (ICH Q3A)
  • Drug Product Impurities and Degradation Products (ICH Q3B)
  • Potential Genotoxic Impurities (FDA Guidance 2008 and EMEA Guidance 2006)

2. General Impurities

  • Residual Solvents
    • Understanding the requirements
      1. Solvents covered
      2. Classes of solvents
    • PPM and PDE
    • Testing methodology
  • Elemental Impurities
  • Understanding the requirements
    • Heavy Metals: The current standard
      1. Elements covered
      2. Limits
      3. Testing and methodology
    • Elemental Impurities : The coming standard
      1. Elements covered
      2. Route of administration
      3. Limits
      4. PPM and PDE
      5. Testing and methodology
  • Microbiological and Endotoxins Tests
    • Understanding the requirements
    • 61 Microbial Enumeration Test for Non-sterile Products
    • 62 Tests for Specified Organisms in Non-sterile Products
    • 71 Sterility Test
    • 85 Bacterial Endotoxins Test

3. Lunch

 

4. Drug Related Impurities

  • Process Impurities
    • Chromatographic tests
    • System suitability tests
  • Degradation Products
    • Forced Degradation Studies
    • Chromatographic tests
    • System suitability tests
  • Potential Genotoxic Impurities
    • Understanding the requirements
    • Predicting degradation products
    • Structural alert
5. Break

6. Strategies for Control of Impurities

  • Residual Solvents
    • PPM or PDE?
    • Components or finished product?
    • Reporting results
  • Elemental Impurities
    • PPM or PDE?
    • Components or finished product?
    • Reporting results
  • Microbiological and Endotoxins Tests
    • What tests are required?
    • Components or finished product?
  • Process impurities
    • Drug substance and/or drug product?
    • Establishing specifications
    • Reporting results
  • Degradation products
    • Drug substance and/or drug product?
    • Establishing specifications
    • Reporting results
  • Potential genotoxic impurities
    • Evaluating genotoxicity potential
    • Establishing specifications
    • Reporting results
  • Sample COA
7. Questions

    Who Will Benefit:

    Chemists (Research, Quality Control, and CRO) involved with dissolution method development or testing and their managers, formulators who rely on dissolution data and regulatory affairs/CMC personnel responsible for filings involving dissolution.

    • Laboratory chemists, supervisors or managers responsible for development, testing, release or stability of pharmaceutical drug substances or drug products.
    • Quality Assurance or Regulatory Affairs personnel responsible for review or reporting of data for drug substances or drug products.

    Instructor Profile:

    Greg Martin, is President of Complectors Consulting which provides consulting and training in the area of Pharmaceutical Analytical Chemistry.  He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) 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 has over 30 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for many years.  In addition, he has volunteered for the USP for over 12 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee, where he is a core member of the Residual Solvents Subcommittee.  He is also Chair-elect of the AAPS In Vitro Release and Dissolution Testing Focus Group.  He serves on the Editorial Advisory Board of the Journal of Validation Technology and Journal of GXP Compliance.

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