A well-written SOP is not a static, one-time effort.
It has life. It acts as a foundation, but one that's flexible like a car's frame and suspension, on which compliance can be achieved confidently.
It helps you demonstrate your compliance and say to inspectors: “We know what we are doing — and why.”
Yet, in today's busy, stress-filled workplace, your staff needs (and hopes for) SOPs that are easy-to-follow, quick reads. Fortunately, FDA investigators support that idea, saying: “It’s better to have an easy-to-read process map that you actually follow than to have a detailed SOP that you don’t.”
Yet, in 2015, "inadequate SOPs" was once again a
Top 5 most-frequently-cited Form 483 observation.
You can do better. In fact, you must do better.
Take your first big step toward crafting more effective, compliant SOPs.
Attend this highly-interactive, two-day workshop that will teach you the practical techniques you need for writing fast-read, flexible and compliant SOPs — SOPs that will meet FDA requirements as well as today’s globalized expectations.
Plan Now to Attend and Learn from
An Award-Winning Compliance Expert
This two-day 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 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
Why You Must Attend
SOPs for the 21st Century: Why Less Is More
But don't just take our word for how much you can expect to gain from this two-day interactive workshop. Here are just a few of the kudos and rave reviews John Avellanet has received in previous appearances at FDAnews events:
“John Avellanet is an excellent speaker – one of the best I have ever heard. His message is direct, clear, timely, and relevant. His visuals enhance the message. He also includes many of his personal experiences that further support the discussion. Any organization or conference director would do well to make sure he’s prominent on the program.”
Dr. Paul Pluta
Institute of Validation Technology
“John takes on complicated regulation and breaks it down into easily managed steps and projects applicable to any company.”
Manager, Quality Systems and Validation
“John’s energy kept a normally ‘dry’ topic interesting. He was extremely helpful and listened to all opinions and offered great advice. I wouldn’t have the energy to present the way John does.”
Senior Quality Manager
Why you can't afford NOT to attend
But that's not all. There's one other way you'll benefit in a big way from attending FDAnews' SOPs for the 21st Century: Why Less Is More.
There's no doubt what a challenge it is to write effective, easy-to-read SOPs that work for your staff and are also compliant with FDA regulations.
That's why, in the workshop materials, we've provided the following essential "working tools:"
- Presentation slides
- A set of detailed handouts
- Two templates — the modern SOP and the modern policy
- Two sample SOPs with process maps and forms — ready for immediate implementation
- Two sample policies — ready for you to implement now
- Three sample checklists — ready for you to use right away
- Four quick guides and templates — ready for you to use immediately
- And more….
They'll help you prepare SOPs efficiently, effectively and with confidence.
This two-day workshop is a rare opportunity to learn from an acknowledged expert … to rub elbows with colleagues who daily encounter the same issues that you do … to pick their brains … absorb their knowledge … and develop contacts who'll be invaluable to you all through the year.
There's absolutely no doubt that SOPs for the 21st Century will benefit you in a very significant way. Don't wait. Register TODAY.