Your Clinical SOPs Are Too Long! Reduce Wordy SOPs to Improve Compliance

Quantity Discounts
1 - 9999
1 - 9999
1 - 9999
1 - 9999
Sponsors, CROs and site personnel are buried under the weight of long, overly bloated and wordy SOPs.

A typical clinical SOP starts out being written by the clinical manager as a 4-page document, but by the time it is sent through pharmacovigilance, legal and the medical monitor, everyone adds their two cents and the document balloons to 12-15 pages.

Has this ever happened to you? If so, read on…

Register Today

Too many organizations believe that filing cabinets full of 4-inch SOP binders and reams of paper make an effective program. This is just not the case.

FDAnews has the answers. In 90-minutes, two of the industry’s best clinical SOP experts will teach you how to regain control of your SOP writing process, cut costs from duplicative writing activities and, most importantly, increase compliance.

Attendees will be treated to the following time-tested strategies:

  • Tips and tricks for turning 12-15 page “monsters” no one will ever read and comprehend into 4-page winners that boost learning and compliance
  • The good, the bad and the ugly. Speakers will highlight examples of what makes for good, bad and downright ugly SOP writing
  • How to break the cycle of manufacturing SOPs being used as the template for clinical SOPs
  • Best practices for how to title an SOP and create a well-defined scope — two of the most important elements to a good SOP
  • How to avoid the “everything and the kitchen sink” approach to SOP writing. Speakers will explain that good SOPs only include who does what and how to do it IF it involves a regulatory requirement
  • What 2 questions FDA investigators typically ask you regarding your clinical SOPs

You and your colleagues will participate from the comfort of your own office, conference room or auditorium. No planes, no hotels, no precious time away from work and family — just 90 minutes of solid, interactive learning via the Web.

Register now.

Meet Your Instructors

Steven Steinbrueck, MPH, CCRA, is President of Stonebridge GCP Consulting, where he focuses on good clinical practices and bioethics. His background combines research, healthcare and academic experience. Mr. Steinbrueck started his career as an Army corpsman and a physician assistant in family practice. Prior to founding Stonebridge, he led training in both large pharmaceutical and CRO settings. He served as a CRA and was the clinical director of a physician assistant training program. Currently, he serves on the graduate faculty of The George Washington University.

Elizabeth Bodi is a clinical research Senior Consultant, Halloran Consulting Group, where her focus is training in project management, infrastructure development and delivery of clinical training programs for biopharmaceutical companies. She has vast experience in developing SOPs at Antigenics, INC, MTRA/AAI, PAREXEL and Covance, where she also developed both basic and specialized CRA and GCP training courses.

Register now!

Here’s a suggested list of potential participants from your organization:

  • Compliance officials
  • QA/QC personnel
  • Regulatory affairs professionals
  • Training personnel
  • Procedural document writers
  • Clinical operations personnel
  • Clinical investigators
  • Clinical research coordinators
Date: Sept. 13 - Oct. 5, 2012
Location: Your office or conference room (no need to travel!)
Time: Anytime

Gather your team for maximum benefit! Your investment is for one dial-in.

Interested in registering multiple sites?

Significant tuition discounts are available for three or more sites from
the same company. You must register at the same time and
provide a single payment to take advantage of the discount. Register below
by clicking on add to cart and then change your quantity in the shopping cart.
The discount will be calculated automatically.

3-4 sites – 10%
7-9 sites – 20%
5-6 sites – 15%
10+ sites – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
with any questions.

We accept American Express, Visa and MasterCard. Make checks payable to FDAnews.

Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Registrations may not be cancelled. Please contact customer service to make any substitutions.

Interested in Becoming a Speaker?
We're always looking for industry leaders eager to share their expertise at an FDAnews audioconference, webinar or physical conference. Our seasoned speaker community includes executives in the pharmaceutical, medical device and clinical trial industries, regulatory affairs, quality control, compliance, healthcare and academia, as well as several former — and current — top FDA officials. Click here to complete our speaker opportunity form and have a representative contact you about future opportunities.