Agenda: Developing World-Class SOPs

Home
Agenda
Log In

Developing World-Class SOPs: Optimizing Quality and Compliance

Developing World-Class SOPs

A WCG FDAnews Virtual Workshop
Wednesday, June 7, 2023 – Thursday, June 8, 2023, 10:00 AM – 3:00 PM EDT

Agenda

Wednesday, June 7, 2023
Thursday, June 8, 2023

10:00 AM

Welcome and Intro; Regulatory expectations; Lessons learned and real-world costs; Common problems and easy solutions

10:00 AM - 11:30 AM

11:30 AM

11:30 AM - 11:45 AM

11:45 AM

QMS structure; Hierarchy; Process approach

11:45 AM - 12:30 PM

12:30 PM

12:30 PM - 1:30 PM

1:00 PM

SOP Outline and format

1:00 PM - 2:00 PM

2:00 PM

Afternoon Break

2:00 PM - 2:15 PM

2:15 PM

Understanding user, reader, audience; Exercise 1

2:15 PM - 3:00 PM

10:00 AM

Review; Steps to writing SOPs; Meet regulatory requirements; Provide adequate level of detail on how, who, when, where; Make SOPs clear and concise; Keep it simple

10:00 AM - 11:30 AM

11:30 AM

11:30 AM - 11:45 AM

11:45 AM

11:45 AM - 12:30 PM

12:30 PM

12:30 PM - 1:00 PM

1:00 PM

Mistake proofing; Document controls, GMPs

1:00 PM - 2:00 PM

2:00 PM

Afternoon Break

2:00 PM - 2:15 PM

2:15 PM

Implementation and training; Inspection readiness; Exercise 3

2:15 PM - 3:00 PM

3:00 PM

3:00 PM

Time Zone: (UTC-05:00) Eastern Time (US & Canada) [Change Time Zone]

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

www.fdanews.com

Privacy Policy Terms of Use Do Not Sell or Share My Data

© 2023 WCG FDAnews