Writing and Enforcing Effective SOPs 2016

Key Topics

• Tips that help and work when you need to create, clear, concise procedures
• The SOP end user, required sections and best practices for SOP development
• Development and formatting recommendations: Content and Structure
• Improve your writing skills
• FDA and overall global expectations and requirements for SOP development, implementation and enforcement
• Reminders that you need to know when you critique your own procedures
• Provide appropriate level of details and use writing conventions
• Create SOPs for the target audience
• Understand the industry standards for procedure writing, including typical components of documents, and using document templates
• Have increased confidence in planning and writing your SOPs
• Understand how training is integral to document approval
• Understand the full life cycle of SOPs
• Identify ways to avoid or reduce risk of regulatory compliance through better writing of your procedures
• Control, archival and disposal
• Write a concise, unambiguous SOP for its intended purpose and stay on-point and on-message
• Use various tools such as flowcharting to define a logical procedure
• Link SOPs to good documentation practices
• Ensure the document is written for the correct audience
• Define clear responsibilities, roles and goals for personnel involved in SOP development

Who should Attend

Attendees involved or interested in:

• Clinical Affairs
• Regulatory Affairs
• Compliance
• Quality Assurance/Quality Control
• Manufacturing and Technical Services
• Marketing & Sales
• IT/MIS
• Engineering
• Laboratory Operations
• Executive Management
• Clinical Research managers and personnel
• Customer Service
• QA/RA managers and personnel
• Specialists/SMEs in all departments
• Distributors/Authorized Representatives
• Quality System auditors
• Consultants
• Legal Counsel