Research and Markets has announced the addition of the "Writing and Enforcing Effective SOPs" conference to their offering.
Who Should Attend:
- Regulatory Affairs
- Clinical Affairs
- Quality Assurance/Quality Control
- Compliance
- Marketing & Sales
- Manufacturing and Technical Services
- Engineering
- IT/MIS
- Executive Management
- Laboratory Operations
- Customer Service
- Clinical Research managers and personnel
- Specialists/SMEs in all departments
- QA/RA managers and personnel
- Quality System auditors
- Distributors/Authorized Representatives
- Legal Counsel
- Consultants
Agenda:
Day 1 Schedule
Lecture 1: The SOP end user, required sections and best practices for SOP development
Lecture 2: Tips that help and work when you need to create, clear, concise procedures
Lecture 3: Improve your writing skills
Lecture 4: Development and formatting recommendations: Content and Structure
Lecture 5: Reminders that you need to know when you critique your own procedures
Lecture 6: FDA and overall global expectations and requirements for SOP development, implementation and enforcement
Lecture 7: Create SOPs for the target audience
Lecture 8: Provide appropriate level of details and use writing conventions
Lecture 9: Have increased confidence in planning and writing your SOPs
Lecture 10: Understand the industry standards for procedure writing, including typical components of documents, and using document templates
Day 2 Schedule
Lecture 1: Understand the full life cycle of SOPs
Lecture 2: Understand how training is integral to document approval
Lecture 3: Control, archival and disposal
Lecture 4: Identify ways to avoid or reduce risk of regulatory compliance through better writing of your procedures.
Lecture 5: Use various tools such as flowcharting to define a logical procedure
Lecture 6: Write a concise, unambiguous SOP for its intended purpose and stay on-point and on-message
Lecture 7: Ensure the document is written for the correct audience
Lecture 8: Link SOPs to good documentation practices
Lecture 9: Define clear responsibilities, roles and goals for personnel involved in SOP development
For more information about this conference visit http://www.researchandmarkets.com/research/klj4p8/writing_and
View source version on businesswire.com: http://www.businesswire.com/news/home/20161202005510/en/
Contacts:
Laura Wood, Senior Manager
press@researchandmarkets.com
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Related
Topics: Pharmaceutical
Manufacturing