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

$1,797.00
SAVE more when you register your team now!

It’s FDA inspection day.

You’ve invested thousands of hours in your standard operating procedures (SOPs) — and you’ve got a towering stack of them to prove it. Think you’ve done everything right?

Think again.

If you receive an FDA warning letter, chances are 6 in 10 it will say that you still haven’t addressed “your firm’s lack of established procedures.”
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:

  • 10 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.



Click here to view the agenda!

 



Click here to view the entire brochure!

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

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 that lurk 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 for this limited-seating workshop now.

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

If you’re tasked with writing or enforcing SOPs in the drug, device, diagnostics or biologics industries, this workshop is a must-attend for both you and your team.

Team discounts available — call (888) 838-5578 for details.

David Dills provides independent consultative services in various capacities from premarketing to postmarketing 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. Mr. Dills has served as director of publications, Regulatory & Compliance for the Institute of Validation Technology. Through his work, Mr. 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.

Mr. 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. Mr. 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.

Price and Locations
Space is limited, so be sure and register early.

Remember, the bonus SOP review alone virtually pays for your investment in the two-day workshop tuition price of just $1,797 per person. Tuition includes the SOP review session, plus all workshop sessions, written materials, breakfast and lunch both days, and daily refreshments.

Nov. 5–6, 2009 • Raleigh, North Carolina
Marriott Raleigh Crabtree Valley
4500 Marriott Dr.
Raleigh, NC 27612
Toll Free: (800) 228-9290
+1 (919) 781-7000
www.raleighmarriott.com
Room rate: $149.00 plus 12.75 percent tax
Reservation cut-off date: Oct. 14, 2009

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.

Team Discounts
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 +1 (703) 538-7600 for details.

Interested in Becoming a Speaker?
We're always looking for industry leaders eager to share their expertise at an FDAnews webinar, audioconference 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

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.