Preparing for a Regulatory Inspection

Half-day interactive training program

Course Overview

As we are experienced auditors and we are often audited by government regulatory bodies, we are in a unique position to offer you a course that:

• Shows you how to implement GMP to avoid surprises in government audits
• Greatly reduces the risk of failing an audit or self-inspection
• Provides documented effectiveness of learning (completed quiz)
• Employs interactive exercises, industry-based case studies, hands-on tasks designed to involve and engage the participant
• Emphasizes adult learning principles
• Gives you a participant binder, marked quiz, and course certificate

Course Objectives

• Describe the reasons for regulatory inspections
• Explain the legal basis for inspections
• Discuss the potential outcomes of an inspection
• Distinguish between appropriate and inappropriate behaviors
• Identify proper ways of responding to an auditor’s questions

Who Should Attend?

• Fabricators/manufacturers, packagers/labelers, testers, importers, distributors, and wholesalers in the pharmaceutical and biotechnology industries
• New employees and personnel with or without GMP training

Why Train with Q&C?

• Interactive sessions
• Expert consultant trainers with hands-on industry experience
• Course certificate to fulfill Health Canada’s annual GMP training requirement
• We wrote the book on compliance…literally. Over 150,000 Blue Books have been published and used worldwide since 2002
• Q&C has 25 years regulatory and compliance experience and we specialize in Health Canada remediations
• We host at least one Health Canada audit each month and perform over 30 self-inspections annually

Sign up for an interactive training seminar

$350 per participant