FDAnews Announces — Creating Effective SOPs: How to Turn a Headache Into a Collaborative Success, July 17-18, 2014, Raleigh, NC

SOPs is the problem cited in 60% of all FDA warning letters due how poorly they're written, communicated, monitored and enforced. Attend Creating Effective SOPs and learn how to write SOPs the easy way thanks to step-by-step, SOP-specific strategies.

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Creating Effective SOPs

Creating Effective SOPs

"David was excellent! He brought serious applicable and pertinent industry examples that can really be applied."— Controlled Documentation Manager, Takeda Global, Research & Development

Falls Church, VA (PRWEB) May 09, 2014

Creating Effective SOPs:
How to Turn a Headache Into a Collaborative Success
**Presented by FDAnews and David Dills, Regulatory & Compliance Consultant**
July 17-18, 2014 – Raleigh, NC
http://www.fdanews.com/SOPsRaleigh

What problem is cited in 60% of all FDA warning letters?

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. 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."

Finally, drug and devicemakers have a chance to fix the broken processes, educate staff and get on the FDA's good side.

Why wait for one of the biggest problems to be exposed during an FDA inspection?

Register now for the hands-on workshop that shows attendees how to:

  •     Create clear, effective SOPs that the FDA will approve (and employees can easily adopt)
  •     Take current SOPs to the next level with easy-to-master techniques
  •     Apply eight SOP audit strategies that tell if staff has gone astray
  •     Determine SOP needs (there's often more than meets the eye)
  •     And more

Not a “natural writer?” No problem. Register for this workshop and write SOPs the easy way thanks to step-by-step, SOP-specific strategies like:

  •     10 writing tips that help craft clear, concise SOPs — every time
  •     3 essential elements of all great SOPs
  •     6 things to consider when critiquing SOPs
  •     5 best practices to rely on for SOP approval, review and revision
  •     8 ways to tell if employees are following (or undermining) SOPs
  •     Plus many others

So whether attendees are new to SOPs or seasoned professionals, get ready to roll up the sleeves and dig in. This vital workshop is perfect for those involved in the drug, biologics, device or diagnostics industries.

Register today and discover what it takes to:

  •     Avoid FDA scrutiny by knowing SOP red flags and trigger points
  •     Choose a "gatekeeper" who should maintain the SOP library
  •     See how current workflow processes may be hurting SOPs using gap analysis
  •     Know precisely how many steps (and sub-steps) needed in a procedure
  •     Learn risk-free from FDA warning letter samples and Form 483s
  •     And much, much more

Meet the Instructor
David R. Dills, an Independent Regulatory & Compliance Consultant, with an accomplished record and more than 20 years of hands-on experience, with emphasis on Class I/II/III medical devices, in vitro diagnostics, and pharmaceuticals in the areas of QA, regulatory affairs and compliance. Since 2000, he has provided consultative services on behalf of global manufacturers, subcontracted for third-party consultancies and provided services involving all key stages of the product development, submission and commercialization.

Conference Details
Creating Effective SOPs:
How to Turn a Headache Into a Collaborative Success
**Presented by FDAnews and David Dills, Regulatory & Compliance Consultant**
July 17-18, 2014 – Raleigh, NC
http://www.fdanews.com/SOPsRaleigh

Tuition: $1,797

Easy Ways to Register
Online: http://www.fdanews.com/SOPsRaleigh
By phone: 888-838-5578 or 703-538-7600

About FDAnews
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.


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