SOPs: A Ticking Time Bomb:Writing and Enforcing Effective SOPs to Assure GxP Compliance
It’s FDA inspection day.
You’ve invested thousands of hours in your standard operating procedures (SOPs) — and you’ve got a towering stack of them to prove it. Think you’ve done everything right?
If you receive an FDA warning letter, chances are 6 in 10 it will say that you still haven’t addressed “your firm’s lack of established procedures.”
Why wait for that ticking “SOP time bomb” to explode? Register now for the hands‑on workshop that shows you how to:
- Create clear, effective SOPs that the FDA will approve (and your employees will readily adopt)
- Take your current SOPs to the next level with easy-to-master techniques
- Apply eight SOP-audit strategies that tell you if your staff has gone astray
- Determine your SOP needs (there’s often more than meets the eye)
- And more!
Not “a natural writer”? No problem. Register for this workshop, and you’ll soon be writing SOPs the easy way ... thanks to step‑by‑step, SOP‑specific strategies like:
- 10 writing tips that help you craft clear, concise SOPs — every time
- Three essential elements of all great SOPs
- Six things you MUST consider when critiquing your own SOPs
- Five best practices to rely on for SOP approval, review and revision
- Eight ways to tell if your employees are following (or undermining) your SOPs
- Plus many others
So whether you’re new to SOPs or a seasoned professional, get ready to roll up your sleeves and dig in. This vital workshop is perfect if you’re involved in the drug, biologics, device or diagnostics industries.
Register today and discover what it takes to:
- Avoid FDA scrutiny when you know these SOP red flags and trigger points
- Choose your “gatekeeper” — who should maintain your SOP library
- See how your current workflow processes may be hurting your SOPs, using gap analysis
- Peer inside the FDA — how SOP investigators are trained (and what they look for!)
- Break down your SOP silos: how to develop a corporate- and department-wide SOP implementation process
- Know precisely how many steps (and sub-steps) you’ll need in a procedure
- Learn risk-free from FDA warning letter samples and Form 483s
- And much, much more
Are you stuck with a “nightmare” SOP? (Who isn’t?!)
Bring it to the workshop and we’ll fix it for you … Free.
Simply bring along the problem SOPs that lurk in your files, then sit back as the expert staff and your fellow attendees polish them to perfection.
This focused review alone is worth the price of admission! To claim your workshop BONUS, you’ll need to register for this limited-seating workshop now.
Plus, you’ll enjoy your two full days learning from the SOP expert who Johnson & Johnson called a “passionate instructor who tells it like it is ...”