8:30 a.m. – 9:00 a.m.

Registration and Continental Breakfast

9:00 a.m. – 9:15 a.m.

Introduction and Welcome

9:15 a.m. – 10:45 a.m.

SOPs and Policies - What’s Really Required?

  • Core regulatory requirements — FDA, EMA, ISO and more
  • Guidances — what you don’t know will hurt you
  • How to quickly parse warning letters for SOP expectations
  • FDA investigator questions to expect about your SOPs and policies
  • Interactive Exercise — Attendees act as FDA investigators and company personnel to review SOPs to identify the proof FDA expects to see during an inspection to prove the SOP was followed

10:45 a.m. – 11:00 a.m.


11:00 a.m. – 12:00 p.m.

Practical Reality — the Business Costs of Poor SOPS and Policies

  • Real world business costs of poor SOPs and policies
  • Practical quality costs of poor SOPs and policies
  • Interactive Exercise — Attendees role-play through several case-study SOPs and compare typical SOPs to their modernized, simplified and streamlined versions

12:00 p.m. – 1:00 p.m.


1:00 p.m. – 2:15 p.m.

Critical SOP Components to Prove Compliance

  • Take advantage of the Policy-SOP-Task Outline hierarchy
  • Understand the role of adult comprehension and retention
  • SOP format and structure for the 21st century — why less is more
  • Why every SOP needs to generate a record
  • How to use forms, checklists, and templates to reinforce compliance
  • Where do definitions belong in the era of wikis and intranets?

2:15 p.m. – 2:30 p.m.


2:30 p.m. – 4:30 p.m.

Process Mapping

  • Why FDA, your staff and your management like to see process maps
  • Why process maps help in the “big picture”
  • Process mapping rules
  • How to process map like a pro
  • Ways in which to use a process map — from training to auditing
  • Sneaky ways to use process maps to achieve 100% compliance
  • Interactive Exercise — Attendees work in teams to process map several case study SOPs

4:30 p.m. – 5:00 p.m.

Day One Wrap Up and Review

  • Interactive Exercise — Attendees identify 3 compelling reasons for personnel at their own company why they should update and streamline their SOPs and policies