SOPs and Policies for the 21st Century: Why Less Is More


9:00 a.m. – 9:15 a.m.

Day Two Welcome and Quick Learning Recap

9:15 a.m. – 10:30 a.m.

SOP Metrics to Prove Effectiveness

  • Why metrics are important to a culture of compliance
  • Why management (and FDA) want to see metrics
  • Simple metrics that work for SOPs and policies
  • When to review metrics — and when not to
  • Interactive Exercise — Attendees draft a follow-up action plan from several case study SOP metrics to improve compliance

10:30 a.m. – 10:45 a.m.


10:45 a.m. – 12:00 p.m.

Advanced Tactics to Reduce Overhead and Lighten Your Workload

  • How to best use photographs in SOPs
  • Mistakes to avoid in your “SOP of SOPs”
  • Steps to foster self-compliance using self-assessments
  • How to write an SOP to oversee an activity you’ve outsourced
  • The easy — and critical — role for senior management
  • Interactive Exercise — Draft a communication to be sent out by your senior team to all company employees about Quality Systems SOPs that will actually lower your workload and encourage self-compliance

12:00 p.m. – 1:00 p.m.


1:00 p.m. – 2:00 p.m.

Writing for the Right Audience

  • Tips on writing for a line worker
  • Tips on writing for an office worker
  • Tips on writing for scientists and engineers
  • Tips on writing for management
  • Interactive Exercise — Attendees analyze and select phrases, words, and document structures best suited to ensuring compliance among different types of workers, managers, and contractors

2:00 p.m. – 2:15 p.m.


2:15 p.m. – 3:30 p.m.

Making SOP Training “Sticky”

  • How to design a training session for adult information retention
  • How to craft engaging slides and other training materials
  • Types of SOP hands-on materials for the factory line and the office
  • Ways to use training to handle one-off details not in SOPs
  • Interactive Exercise — Work in teams to outline a sample, hands-on training session for two different SOPs

3:30 p.m. – 4:00 p.m.

Building Your Business Case to Streamline Your SOPs & Policies

  • Interactive Exercise — Attendees work with the expert instructor to draft their own personal, business case and prioritized plan for streamlining and modernizing their quality system SOPs and policies

4:00 p.m. – 4:30 p.m.

Wrap Up and Final Questions

4:30 p.m.