Writing Effective SOPs for the GMP Laboratory
About This Event
Description
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.
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.
For Registration
http://onlinecompliancepanel.com/webinar/WRITING-EFFECTIVE-SPOs-GMP-LABORATORY-501541/JULY-2016-ES-WORLDCONCAL
Note: Use Promo code NEROC and get 10% off on registration (Valid till July 31st 2016)