SOPs: A Ticking Time Bomb Writing and Enforcing Effective SOPs to Assure GxP Compliance
Product Details
Hint #1: It's a process issue - within your power to control and change.
Hint #2: It spans multiple departments or divisions of your company.
Hint #3: It's likely something you use every week.
Give up?
It's SOPs. Not the lack of them, but how poorly they're written, communicated, monitored and enforced.
One former top FDA official recalls walking into dozens of companies and being shown stacks of SOPs hot off the photocopier. But when he talked to lab and plant staff, the response was always the same. "What SOPs?" or, "Yeah, we saw them, but we're not sure what they mean."
Don't blame yourself, though. Ever hear the old saying, "It takes a village to raise a child"? Well ... It takes a company to write an SOP.
Finally, you and your colleagues have a chance to fix your broken processes ... educate your staff ... and get on the FDA's good side.
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:
- Ten 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.
Are you stuck with a "nightmare" SOP? (Who isn't?!)
Simply bring along the problem SOPs in your files, then sit back
This focused review alone is worth the price of admission!
Plus, you'll enjoy your two full days learning from the SOP expert |
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
Here's what previous attendees have to say:
"David was excellent! He brought serious applicable and
pertinent industry examples that can really be applied."
Danielle Moyles, Controlled documentation manager, Takeda Global,
Research & Development
"Great class, focused on how to write SOPs and the FDA's expectations."
Alin Iancu, Quality manager, Sandvik Medical Solutions