Inspections CrackdownUsing Process Mapping, Gap Analysis and SOP Review to Stay Ahead of the FDA
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Process maps ... flow charts ... gap analysis ... visual methods that simplify the complex, transforming processes into graphs, charts and pictures you grasp at a glance.
Yes, they’re easy to understand ... and yes, they’ll help you revise or create SOPs that ward off the FDA’s aggressive new enforcement initiatives ... but no, you can’t just grab a box of crayons and draw a process map.
For example, let’s say your SOP calls for product to move straight from the production line to QC. Sounds simple enough. But you know that when QC gets backed up, the product ends up in a nonsterile holding room — a serious cGMP violation. This is where process mapping, gap analysis and the resulting SOP revision process can assure you’re in compliance.
To help make sure what really happens in your facility matches up with what is supposed to happen according to your SOPs, FDAnews has organized an internet “chalk talk” to get you up to speed on:
- What process mapping and gap analysis are
- How their use leads to creation of FDA-compliant SOP reviews
- How to develop detailed process maps that illustrate the way your company’s manufacturing processes operate in real life
- Who to assign to the process mapping team and who to leave off
- Using gap analysis to determine whether an SOP may be revised or if it must be replaced
- Tracking procedures that assure gaps are fixed before the investigators visit
Your instructor, auditing whiz Kerry Potter, illustrates the presentation with sample process maps ... explains how to ensure your process maps represent reality, not what’s “supposed” to happen ... helps you spot inconsistencies between process maps and SOPs ... and much more. Wonder what those odd-looking map objects symbolize? Potter explains. Still confused? Not to worry. The session is totally interactive — just send in your questions for prompt answers.
In 90 fact-packed minutes, without ever leaving your office, you’ll gain understanding of powerful management tools that help you stay compliant — and, perhaps more importantly, gain control of process and workflow for more cost-effective manufacturing and greater profits.
There’s no limit on the number of participants at the same location. The price is the same whether it’s one, a dozen or a hundred. Can you afford not to sign up?