Writing Effective SOPs for the GMP Laboratory

Duration: 90 Minutes
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.
Writing Effective SOPs
Instructor: Gregory Martin
Product ID: 501541
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.

Areas Covered
  • 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
Who can Benefit
  • Quality Assurance
  • Documentation and Technical Writing
  • Quality Control Laboratory
  • Regulatory Affairs
  • Contract Laboratory
  • Analytical Laboratory
  • Project Management
  • Consultants
$375
Recorded Session for one participant
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How it works
Live Session - How it works
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  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Greg Martin is the President of Complectors Consulting, which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years experience in the pharmaceutical industry and was the 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 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 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 is the author of several papers in the areas of dissolution and analytical method validation, and was the past chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.
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