Creating Effective SOPs

Conference

Creating Effective SOPs:
How to Turn a Headache Into a Collaborative Success

Raleigh, NC • July 17-18, 2014

Agenda

 

DAY ONE

8:00 a.m. – 9:00 a.m.

Registration/Continental Breakfast

9:00 a.m. – 10:30 a.m.

FDA and International Regulatory Requirements and Expectations

  • Rapid review of FDA and international requirements
  • How the FDA trains its investigators to review procedures/SOPs and what company auditors should be reviewing
  • Review of recent FDA warning letter citations/Form 483 observations specific to operational procedures
  • INTERACTIVE EXERCISE! Getting your feet wet — small group review of sample SOPs to assure everyone is on the same page
     

10:30 a.m. – 10:45 a.m.

Break

10:45 a.m. – 12:00 p.m.

Best Practices for SOP Development and Formatting

  • 10 writing tips you need to create clear and effective SOPs
  • What works and what doesn’t in formatting and content
  • INTERACTIVE EXERCISE! Analyze and critique templates/SOP examples
  • What writing style are you?  Analyzing various styles and determining what best suits your purpose
     

12:00 p.m. – 1:00 p.m.

Lunch

1:00 p.m. – 2:00 p.m.

Step-by-Step Guide to Determining Optional SOP Formats

  • Flow diagram and developing the process
  • How many steps and sub-steps are there in a procedure?
  • What is the objective of an SOP (Purpose)
  • What is the applicability and use of an SOP (Scope)
  • Who will perform tasks (Responsibility)
  • Who will ensure implementation of procedure (Accountability)
  • How tasks will be performed (Procedure)
     

2:00 p.m. – 3:00 p.m.

What’s in a Word?  Choosing Content and Structure That Creates Effective SOPs

  • Examples of content and structure from GMP, GLP, GCP environments
  • INTERACTIVE EXERCISE! Bring in your toughest, most problematic SOPs and we’ll review, critique and offer suggestions
     

3:00 p.m. – 3:15 p.m. 

Break

3:15 p.m. – 5:00 p.m.

Maintenance of SOPs — It Doesn’t Have to Be Such a Burden

  • Creating efficient review and approval procedures that fit your corporate structure
  • Best practices for SOP review, approval, and revision
  • Breaking down silos — how to develop a corporate/department-wide SOP implementation process
  • Tips for document distribution, retrieval and archiving
  • Determining who should be the “gatekeeper” and who should maintain your SOP library
     

DAY TWO

8:00 a.m. – 9:00 a.m.

Continental Breakfast

9:00 a.m. – 10:30 a.m.

Reminders From Day One and Advanced SOP Writing Techniques

  • Can an SOP be perfect? Reviewing well written SOPs
  • 3 things all great SOPs contain
  • Balancing the concerns of underwriting and overwriting — 6 things to consider when you critique your own SOPs
     

10:30 a.m. – 10:45 a.m.

Break
 

10:45 a.m. – 12:00 p.m.

Compliance and Training:  Even the Best Written SOPs Will Fail if They Are Not Followed!

  • Auditing your SOPs — strategies for determining if staff are following procedures
  • Integrating SOPs and detailed audit checklists
  • Red flags or trigger points that the FDA looks for in SOP compliance and training
  • Cooperative strategies to enforce your procedures
     

12:00 p.m. – 1:00 p.m.

Lunch
 

1:00 p.m. – 2:30 p.m.

Class Project

  • Top strategies for determining SOP needs — there’s usually more than meets the eye
  • Gap analysis of how your current workflow processes may be contributing to
  • deficiencies in existing SOPs
  • SOP system and library management
  • INTERACTIVE EXERCISE! How to apply the learned techniques to specific operations.  You’ll take home a well-honed SOP on your toughest procedure