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 highly-interactive, two-day 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 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
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:
“Glad I attended, the “before” and “after” SOP was really powerful. Can't wait to implement this style at my company. Lots of “ammo” provided to sell this to senior management. Smarter and better business sense to work SOPs this way. All about bottom line. Great speaker, lots of wonderful information. In drug safety 20 years, learned a lot! Wonderful insights to save time, effort and company money. It's always difficult to know where FDA is coming from regarding auto findings and this was really helpful.”
Colleen McMahon, Pharmacovigilance Lead, Spark Therapeutics
“John was great and very knowledgeable. Easy to talk to and open to discussion. The information he gave us was great and he had a ton of real experience. Really relevant to the current policies and procedures and compliant with all current regulations.”
Kendra McClure, Quality Assurance Supervisor, Geodis, LLC
“John was FABULOUS, entertaining and knowledgeable. I thought this workshop would be beneficial but boring. I was wrong. This was not boring at all. I had fun and on top of that, I learned so much information that I can take back for my company and individual success.”
Jennessa Martin, Regulatory Affairs Specialist, Fibrocell Technologies
“John is an exceptional and credible instructor. He is personable, funny and clear in his presentation and training skills. He provides real life examples. He answers questions and concerns that each of us may have. He is very direct and to the point with his explanations which is greatly appreciated.”
Phyllis Hill, Procedural Document Writer, Bristol-Myers Squibb
“I now have a clear vision on how to write and simplify future SOPs and supporting materials for my company.”
Roxanne Marshall-Frank, Procedural Document Manager, Bristol-Myers Squibb
“I liked the real-world exercises and examples and how the subject matter fits with my organization's current initiative. John was very engaging and showed excellent subject area knowledge.”