This course provides helpful information by presenting topics associated with the writing, formatting, execution and management of SOPs & MBRs that contribute to consistent and efficient operations. It also discusses good documentation practices required by companies to ensure GMP compliance and relates the role which SOPs & MBRs play in achieving the required level of compliance and quality.

_{^{Who Should Attend}}

• Quality Assurance
• Production
• Laboratory
• Documentation
• Compliance
• Regulatory Affairs

_^Outlines

• Good Documentation Practices
• Regulatory inspectors expectations for SOPs & MBRs
• The role of SOPs & MBRs with respect to manufacturing and GMP operations, global harmonization, documentation and document control
• Reviewing current SOPs & MBRs to determine gaps and overlaps to strengthen the existing documentation system
• Maintenance of SOPs & MBRs
• Designing SOP & MBR templates to optimize efficiency of organization
• The team approach to SOP & MBR writing, defining responsibilities and knowing the audience
• The importance of capturing the actual flow of an operation within the document
• Writing tips on how to keep the document concise, unambiguous and accurate
• Training of SOP & MBR documents
• Managing revisions and deviations through a document Change Control System