A well-written SOP helps demonstrate compliance and says to inspectors that a company knows what it’s doing and why. Join Susan Schniepp, a quality assurance thought leader veteran of 35 years on May 24 for a 1-hour webinar where she’ll explain what an SOP needs to be deemed “adequate” by the FDA and how to make SOPs so clear that employees will follow the plan the same way, each and every time.
Falls Church, VA (PRWEB) May 04, 2016
Everyone thinks writing SOPs is old hat. Yet “inadequate SOPs” remains in the top five 483 citations.
Who doesn’t want to end this cycle?
Plan to devote just one hour — that’s right, one hour — to listen to what Susan Schniepp has to say on the subject.
Susan has spent the last 35 years as a quality assurance thought leader at multiple pharma companies and has served as chair of PDA’s Regulatory Affairs/Quality Advisory Board.
She’ll tell manufacturers what an SOP needs to be deemed “adequate” by the FDA — and how to make SOPs so clear that employees will follow the plan the same way, each and every time.
Wouldn’t that be nice?
Here’s what else attendees will learn:
- 7 things to include in SOPs
- 7 things — besides the procedure itself — that must be included
- How to balance between streamlined efficiency and in-depth understanding
- How good SOPs work together seamlessly
- How to track evolution of SOPs
- How to define SOPs roles for supervisors and operators
- And much more…
Register today for SOPs advice from a proven industry leader.
Meet the Presenter:
Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc. As a pharmaceutical quality assurance thought leader with 35 years’ experience, Sue has held leadership roles in industry at Allergy Laboratories, Inc., OsoBio Pharmaceuticals, LLC, Searle, Abbott and Hospira. She has served as a member of PDA’s Board of Directors, PDA / FDA Joint Regulatory Affairs Conference Chair, conference presenter, and Chair of the PDA’s Regulatory Affairs / Quality Advisory Board, and was awarded PDA’s Distinguished Service Award in 2008.
Who Will Benefit:
- Executive Management
- Regulatory Affairs
- Quality Assurance/Quality Control
- Legal and Compliance Officers
- Clinical Research Directors
- Consultants/Service Providers
- CAPA Specialists
- Compliance Information Managers
- GMP Compliance Officers
- GMP Training Managers
- Heads of Internal Audits
- QA Documentation Managers
- QA/QC Managers and Directors
- Quality Systems Managers
- Systems Analysts
- Training Personnel
$287 per site
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For the original version on PRWeb visit: http://www.prweb.com/releases/FDAnews/writingeffectivesops/prweb13387855.htm