SOPs: A Ticking Time Bomb Writing and Enforcing Effective SOPs to Assure GxP Compliance

$1,797.00
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 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.



Click here to view the brochure.

 



Click here to view the agenda.

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?!)
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 ..."

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

Whether you’re a novice or experienced professional, you'll find this unique roll-up-your-sleeves and dig-in workshop exactly what you need if you’re involved in the drug, biologics, device or diagnostics industries. Anyone associated with writing and enforcing SOPS will call this the go-to workshop of the year.

David Dills provides independent consultative services in various capacities from pre-marketing to post-marketing within the technical, quality, regulatory affairs and compliance arenas to pharmaceutical, Class I/II/III medical devices, in vitro diagnostics and biologics/biotech companies with an emphasis on establishing sustainable compliance systems. Dills has served as director of publications, Regulatory & Compliance, for the Institute of Validation Technology. Through his work, Dills has been affiliated with the life sciences industry for more than 19 years with increasing responsibilities in QA, quality engineering, validation, RA/compliance, and corporate/operations management. He was previously employed on behalf of globally recognized device manufacturers and service providers in conjunction with marketing and business development responsibilities.

Dills' areas of interest and expertise include executing process validation, supplier qualification, training, internal/due diligence audits, policy/procedure development, PM, risk management/assessment, ISO 9001/13485/14971, MDD 93/42/EEC, CE Marking, remediation, GxPs, SW validation/IT network, MDR/AE/product complaints, design/change control, CAPA, PMA, IDE, 510(k), NDA and e-CTD/CMCs submissions, interfacing with international regulatory bodies, QSIT and PAI inspections, sample accountability, and other related functions and tasks. Dills' academic degrees include environmental science and biology. He currently serves as advisor for the ASQ's Section 1506 and as a former chair and co-chair. He is an active member of the Biomedical Division, RAPS, PDA, ISPE and other industry working groups.

Dates and Locations

May 18–19, 2010 • Boston, MA
Hyatt Regency Boston
1 Avenue De Lafayette
Boston, MA 02111
Toll Free: (800) 233-1234
+1 (617) 912-1234
www.regencyboston.hyatt.com
Room rate: : $229.00 (plus 14.45% tax)
Reservation cutoff date: April 26, 2010

Sept. 23–24, 2010 • Raleigh, NC
Marriott Raleigh Crabtree Valley
4500 Marriott Drive
Raleigh, NC 27612
Toll Free: (800) 228-9290
+1 (919) 781-7000
www.raleighmarriott.com
Room rate: $149.00 (plus 12.75% tax)
Reservation cutoff date: Sept. 1, 2010

Register Early — Space is Limited

Hurry — register early because space is limited! Your tuition of $1,797 per attendee includes the two-day workshop, all conference materials, continental breakfast and lunch each day.

Send Your Team for Maximum Benefit
Get your team up to speed in just three days!

Significant tuition discounts are available for teams of three or
more from the same company. You must register at the same time and
provide a single payment to take advantage of the discount.

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600 globally
to learn about our special multisite discount.

 

Payment is required by the date of the conference. 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.

Cancellations and Substitutions
Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 21 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.