Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions
Think about your next FDA inspection. How will you feel when the inspection arrives at your facility? Will you be rushed or calm? Flustered or confident? Perhaps more importantly, who will control the direction of the inspection? You… or the inspector?
Unannounced Doesn’t Mean Out of Control
You may not know the date or time of your next FDA inspection. You certainly won’t be able to anticipate every question an inspector will ask. However, this uncertainty doesn’t mean that an FDA audit is completely out of your control. With the right legwork, you can steer the audit’s course from the moment an auditor knocks on your door.
Key Areas for Preparation
Staying prepared is the best way to ensure that you maintain control during an FDA audit. That preparation extends beyond your quality system records. It also includes the process that should kick in when an auditor arrives, general procedures you should have in place for regulatory audits, coaching your team on audit etiquette, and more.
Our latest e-book, Prepare to Succeed: Stay Ready for Your Next FDA Audit, gives you actionable strategies to prepare yourself, your team, your site, your quality system, and even prepare the FDA inspector for a successful quality system audit. It also discusses how our SmartSolve® quality management software will help you quickly demonstrate compliance during an FDA audit.
Key areas covered in the e-book include:
- Policies and procedures that help you stay in control of a regulatory audit
- Audit team training needs
- Information that can help the auditor quickly understand your facility and processes
- Auditor objectives and sample questions for various quality system elements
- SmartSolve reports and records that demonstrate quality system compliance
Prepare to Succeed: Stay Ready for Your Next FDA Audit
A Guidebook for FDA Audit Readiness
This e-book gives you actionable strategies to prepare yourself, your team, your site, your quality system, and even prepare the FDA inspector for a successful quality system audit.
How do you prepare for FDA audits? Please share your thoughts in the comments below.