The Writing and Enforcing Effective SOPs 2016 is a seminar that covers topics such as:
- 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
The Writing and Enforcing Effective SOPs 2016 brings together 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