Falls Church, VA (PRWEB) May 21, 2015
A well-written SOP is not a static, one-time effort.
It has life. It acts as a foundation, but one that's flexible like a car's frame and suspension, on which compliance can be achieved confidently.
It helps to demonstrate compliance and says to inspectors that the manufacturer knows what it’s doing and why.
Yet, in today's busy, stress-filled workplace, a staff needs (and hopes for) SOPs that are easy-to-follow, quick reads. Fortunately, FDA investigators support that idea, saying: “It’s better to have an easy-to-read process map that manufacturers actually follow than to have a detailed SOP that they don’t.”
Yet, in 2014, "inadequate SOPs" was once again a Top 5 most-frequently-cited Form 483 observation.
It can be done better. In fact, it must be done better.
Take the first big step toward crafting more effective, compliant SOPs.
Attend this highly-interactive, two-day workshop that will teach the practical techniques needed for writing fast-read, flexible and compliant SOPs — SOPs that will meet FDA requirements as well as today’s globalized expectations.
This two-day workshop will be led by John Avellanet, an award-winning FDA compliance expert known for his business-savvy, pragmatic advice and engaging speaking style.
Not only does this workshop provide an opportunity to hear from an acknowledged expert in SOPs, but attendees will also share experiences and learn from their fellow attendees who are confronting the same issues.
Attend this critical workshop and attendees will find out:
- How to quickly parse warning letters and Form 483s for SOP expectations
- What FDA investigator questions to expect about the SOPs and policies
- How to take advantage of the Policy-SOP-Task Outline hierarchy
- How to use forms, checklists, and templates to reinforce compliance
- Where definitions belong in the era of wikis and intranets
- Why FDA, staff and management like to see process maps
- Simple metrics that work for SOPs and policies
- How to best use photographs in SOPs
- What mistakes to avoid in “SOP of SOPs”
- How to write an SOP to oversee an outsourced activity
- Tips on writing for a line worker
- Tips on writing for an office worker
- Tips on writing for scientists and engineers
- Tips on writing for management
But that's not all. There's one other way attendees will benefit in a big way from attending FDAnews' SOPs for the 21st Century: Why Less Is More.
There's no doubt what a challenge it is to write effective, easy-to-read SOPs that work for the staff and are also compliant with FDA regulations.
That's why, in the workshop materials, attendees will receive the following essential "working tools:"
- Presentation slides
- A set of detailed handouts
- Two templates — the modern SOP and the modern policy
- Two sample SOPs with process maps and forms — ready for immediate implementation
- Two sample policies — ready to implement now
- Three sample checklists — ready to use right away
- Four quick guides and templates — ready to use immediately
- And more….
They'll help manufacturers prepare SOPs efficiently, effectively and with confidence.
There's absolutely no doubt that SOPs for the 21st Century will benefit manufacturers in a very significant way.
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
Meet the Workshop Leader:
John Avellanet is an award-winning FDA compliance expert known for his business-savvy, pragmatic advice and engaging speaking style. He was the lead author of several certification courses on Good Manufacturing Practices (GMP) and Quality System Regulation (QSR) supplier management for the US Regulatory Affairs Professional Society. Prior to founding his lean compliance consulting firm, Cerulean Associates LLC, Mr. Avellanet was a former Fortune 50 combination device C-level executive who created, developed, and ran his company’s compliance programs to achieve ISO, DEA, BIS and FDA compliance.
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.