The "Writing and Enforcing Effective SOPs" conference has been added to ResearchAndMarkets.com's offering.

This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents. We will review examples from warning letters and then review the good and bad SOPs and templates. Standard operating procedures work best when they are designed to achieve specific results. Decide what business goals will be achieved through better management with SOPs and how those goals will be measured.

The lack of or inadequate standard operating procedures (SOPs) continues to dominate the FDA's inspectional observations. Following SOPs are much more important than writing them. Even the best written SOPs are useless if they are not followed. SOPs are therefore the most popular documents audited by FDA and other Agencies, and certainly your auditors and customers.

This session will provide insightful and useful information by presenting topics associated with the writing, formatting, execution, management and global harmonization of SOPs. It also discusses good documentation practices required by companies to ensure GMP compliance and relates the role which SOPs play in achieving the required level of compliance and quality.

The employees who will benefit include basically anyone and everyone at your organization who are required to write and/or comply with SOPs, including all levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview of the SOP process from start to finish, including:

  • 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

For more information about this conference visit https://www.researchandmarkets.com/research/nvz76x/writing_and?w=4