A Well-Written Procedure is Written to Direct Staff and Designed to be Followed.
Policies and procedures act as a foundation, but one that's flexible like a car's frame and suspension, on which compliance can be achieved confidently and consistently.
And yet — many compliance pros write procedures for the auditor and not the person who actually has to follow it. Is it more important for the once a year auditor to be happy or for the everyday person to consistently follow the SOP?
While a good SOP helps you demonstrate your compliance and say to inspectors and auditors alike: “We know what we are doing — and why,” the modern SOP enables your business and your compliance success.
In today's busy, stress-filled workplace, your staff needs (and hopes for) SOPs that are easy-to-follow, quick reads. Even regulatory investigators support that idea, saying: “It’s better to have an easy-to-read process map that you can actually follow than to have a detailed SOP that you don’t.”
Take a step toward crafting more effective, compliant SOPs.
Attend this interactive, two-day virtual workshop that will teach you down-to-earth, practical techniques you need for writing fast, flexible and compliant SOPs — SOPs that will meet regulatory requirements and today’s globalized expectations.
Plan Now to Attend and Learn from
An Award-Winning Compliance Expert
This two-day virtual workshop will be led by John Avellanet, an award-winning FDA compliance expert known for his business-savvy, pragmatic advice and engaging speaking style.
Prior to founding his lean compliance consulting firm, Cerulean Associates LLC, John was a former Fortune 50 combination device C-level executive who created, developed, and ran his company’s compliance programs to achieve ISO, DEA, BIS and FDA compliance.
Over the past decade, he has been interviewed on public radio programs, in numerous industry magazines and multiple news outlets. He speaks frequently for industry conferences and private corporate workshops.
A former FDA and US DOJ prosecutor has said of John Avellanet, “He is the best in the business. Period.”
What You Will Learn
Not only does this virtual workshop provide you an opportunity to hear from an acknowledged expert in SOPs, but you'll also share experiences and learn from your fellow attendees who are confronting the same issues as you.
Attend this critical workshop and you'll find out:
- How to quickly parse warning letters and Form 483s for SOP expectations
- What FDA investigator questions to expect about your SOPs and policies
- How to take advantage of the Policy-SOP-Task Outline hierarchy
- How to use forms, checklists and templates to reinforce compliance
- Where definitions belong in the era of wikis and intranets
- Why FDA, your staff and your management like to see process maps
- Simple metrics that work for SOPs and policies
- How to best use photographs in SOPs
- What mistakes to avoid in your “SOP of SOPs”
- How to write an SOP to oversee an activity you’ve outsourced
- 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
Who Will Benefit
- Executive Management
- Regulatory Affairs
- Quality Assurance/Quality Control
- Legal and Compliance Officers
- Clinical Research Directors
- Consultants/Service Providers
- CAPA specialists
- Compliance information managers
- GMP compliance officers
- GMP training managers
- Heads of internal audits
- QA documentation managers
- QA/QC managers and directors
- Quality systems managers
- Systems analysts
- Training personnel