Course Agenda
Day 1 (10:00AM-4:00PM) EST

10:00 – 11:00 AM: Lecture 1: SOPs for a given organization: FDA Requirements
  • Regulations describing SOPs
  • Regulatory requirements for different organizations: sites, manufactures, labs
  • Requirements for various products: Drugs, biologics, devices, diagnostics, clinical labs
  • What processes do not need written SOPs
  • SOPs verses working practices and draft scripts
  • Legal requirements for creating and maintaining SOPs

11:00 – 12:00 PM: Lecture 2: Where to Start: Developing a Strategy
  • Listing tasks for a given organization
  • Qualifications of writing leaders and teams
  • Resource allocation and time-lines
  • Policies and procedures
  • Using Templates: Self-created and acquired

12:00 – 12:30 PM: Break

12:30 – 2:15 PM: Lecture 3: How to Get Started
  • List of SOPs for different organizations: Clinical sites, manufacturing facilities, labs, etc
  • Process development and developing SOP on SOPs
  • Prioritizing tasks
  • Minimum requirements for SOPs
  • Risk-based approach for SOPs
  • Types of SOPs

2:15 – 2:30 PM: Break

2:30 – 4:00 PM: Lecture 4: Writing an SOP: 5 Steps to a Good SOP
  • Format for an SOP
  • Essential Components of an SOP
  • Task split, distribution, and attribution
  • Documentation: Checklist, forms, and reports
  • Annotations
Day 2 (10:00AM-4:00PM) EST

10:00 – 11:00 AM: Lecture 5: Essentials of a SOP Driven Process
  • What is Process Mapping and how can it be best used?
  • Categorization and organization of SOPs
  • Rules for electronic SOPs in the cGMP, GLP and GCP environment
  • Maintaining SOPs
  • Best practices for access control and distribution
  • Archiving, retiring, and audit trails for SOPs

11:00 – 12:00 PM: Lecture 6: Effective Writing Strategies
  • Writing Exercise for SOP
  • Style, tone, and content arrangement
  • Best practices for SOP approval process
  • Electronic verses paper SOPs

12:00 – 12:30 PM: Break

12:30 – 2:15 PM: Lecture 7: Education and Training on an SOP
  • Best practices for training and documenting
  • Periodic reviews
  • Tools for SOP tracking and training validation
  • Train the trainer programs
  • Adapting Generic, Institution, or Sponsor SOPs for your Needs
  • SOP updates
  • Dealing with deviations

2:15 – 2:30 PM: Break

2:30 – 4:00 PM: Lecture 8: Getting Ready for FDA Audits of SOPs
  • Common FDA 483s and Warning Letters regarding SOPs
  • Logistics of an FDA audit
  • Best practices for coordinating FDA review of SOPs
  • Addressing FDA findings
  • Responding to an FDA 483
  • Dos and Don’ts of an FDA audit