The A to Z`s of Writing and Enforcing Effective SOPs (Standard Operating Procedures) 2015 is a conference dedicated to Standard Operating Procedures writing. Topics include:
- Development and formatting recommendations:
- Improve your writing skills
- Tips for creating clear and concise procedures
- The SOP end user, required sections and best practices for SOP development
- Create SOPs for the target audience
- FDA and overall global expectations and requirements for SOP development, enforcement and implementation
- Have increased confidence in planning and writing your SOPs
- Provide appropriate level of details and use writing conventions
- Understand the full life cycle of SOPs
- Understand the industry standards for procedure writing, including typical components of documents, and using document templates
- Control, archival and disposal
- Understand how training is integral to document approval
- Tools to define a logical procedure
- Identify ways to avoid or reduce risk of regulatory compliance through better writing of your procedures
- Ensure the document is written for the correct audience
- LWrite a concise, unambiguous SOP for its intended purpose and stay on-point and on-message
- Define clear responsibilities, roles and goals for personnel involved in SOP development
- Link SOPs to good documentation practices
Who should Attend
Representatives responsible for:
- Quality Assurance/Quality Control
- Manufacturing and Technical Services
- Clinical Affairs
- Regulatory Affairs
- Compliance
- 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
