How to Write SOPs which are Compliant for Inspections for a GXP Compliance 2018

Topics

• Expectations for an effective written documentation
• Why we need written SOP procedures
• Creating effective SOPs and other written documents to minimize costly revisions
• Regulatory requirements for the creation, compliance and maintenance of SOPs
• How training and implementation of SOPs should be carried out to meet inspectors expectations
• Roles and responsibilities for the review and approval of written documents consistent with compliance requirements
• Effective control, archival and disposal of SOPs

Who should Attend

• Clinical Research Associates
• Drug Research and Development Managers and Personnel
• Quality Assurance Managers and Auditors
• Clinical Research Archiving and Document Management Personnel
• Manufacturing
• Clinical Development Managers and Personnel
• Laboratories
• Pharmacovigilance
• Project Management
• CROs
• Sponsors who Have their Own Laboratories for Analyzing Clinical Trial Samples
• Sponsors and Non-Commercial Sponsors
• Laboratories Analyzing Samples from Clinical Trials
• Consultants
• Clinical Trial Supply
• Regulatory Affairs
• To those Departments who have SOPs
• Document Management
• Legal, Regulatory Authorities and all Other Professionals who want to know More about Inspection of SOPs