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.
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.
Why wait for that ticking "SOP time bomb" to explode? Register now for the hands-on workshop that shows you how to:
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:
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?!)
Simply bring along the problem SOPs in your files, then sit back
This focused review alone is worth the price of admission!
Plus, you'll enjoy your two full days learning from the SOP expert
Register today and discover what it takes to:
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
18–19, 2010 • Boston, MA
Hyatt Regency Boston
1 Avenue De Lafayette
Boston, MA 02111
Toll Free: (800) 233-1234
+1 (617) 912-1234
Room rate: : $229.00 (plus 14.45% tax)
Reservation cutoff date: April 26, 2010
23–24, 2010 • Raleigh, NC
Marriott Raleigh Crabtree Valley
4500 Marriott Drive
Raleigh, NC 27612
Toll Free: (800) 228-9290
+1 (919) 781-7000
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.
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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.
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