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Writing Effective SOPs for the GMP Laboratory - Webinar

  • ID: 3784232
  • Webinar
  • 90 Minutes
  • Online Compliance Panel
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This course is designed to provide participants with tools for writing effective Standard Operating Procedures. A general process for creating and implementing SOPs will be presented, including discussion on the important sections which should be included in each SOP, how to generate the consensus ultimately required for the SOPs to be followed consistently, training requirements and post-implementation evaluation and periodic review. We will discuss a list of SOPs which every analytical laboratory should have.

Objectives of the Presentation:

- Understand the rationale for SOPs
- Understand the process for creating and implementing SOPs
- Identify the major sections which should be included in each SOP
- Develop a strategy to maximize the effectiveness and consistent use of SOPs

Why Should you Attend:

Regulatory Agencies require written procedures for all systems and operations which impact the quality and safety of pharmaceutical products. Standard Operating Procedures (SOP's) provide the main forum for the documentation of a Company's systems and operations. SOP's are therefore the most popular documents audited by Regulatory Agencies during GMP inspections to ensure they reflect current practices and are followed as written.
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- Rationale for having Standard Operating Procedures
- Format for SOPs: Sections all good SOPs need
- General Process for Creating New SOPs
- - First draft
- - Circulate for comment
- - Trial use of the SOP
- - Circulation for Approval
- - Implementation
- Training for SOPs
- - New SOPs
- - New employees
- Post-implementation evaluation
- Periodic review of SOPs
- SOPs which each Laboratory should have
- Attendee Questions and Answers
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  • Gregory Martin Mr Gregory Martin,
    President ,
    Complectors Consulting

    Complectors Consulting provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin 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 25 years experience in the pharmaceutical industry and was Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves as Vice Chair of the General Chapters – Physical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Weights and Balances and Use of Enzymes for Dissolution Testing of Gelatin Capsules. 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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- Quality Assurance
- Documentation and Technical Writing
- Quality Control Laboratory
- Regulatory Affairs
- Contract Laboratory
- Analytical Laboratory
- Project Management
- Consultants
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