Creating Effective SOPs


Creating Effective SOPs:
How to Turn a Headache Into a Collaborative Success

Raleigh, NC • July 17-18, 2014

Creating Effective SOPs
How to Turn a Headache Into a Collaborative Success

An Interactive Workshop Presented by FDAnews
and David Dills, Regulatory & Compliance Consultant

What problem is cited in 60% of all FDA warning letters?

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.  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. You’ve heard 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 what you know is one of your biggest problems to be exposed during an FDA inspection? Register now for the hands-on workshop that shows you how to:

  • Create clear, effective SOPs that the FDA will approve (and your employees can easily 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
  • 3 essential elements of all great SOPs
  • 6 things you MUST consider when critiquing your own SOPs
  • 5 best practices to rely on for SOP approval, review and revision
  • 8 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 investigators are trained (and what they look for)
  • Break down your SOP silos: how to develop a corporate- and departmentwide 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 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 now for this limited-seating workshop.

Plus, you'll enjoy your two full days learning from the SOP expert whom Johnson & Johnson called a "passionate instructor who tells it like it is ..."