Recorded Webinar – How to Audit Like the Regulator: Effective Techniques and Common Observations

Recorded Webinar

Time: 3.5 Hours

Cost: CAD$300+HST (50% off of $600 – limited time only)

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Abstract

Auditing of contractors, vendors, and suppliers in the Pharmaceutical industry is not only a regulatory requirement but also a critical Quality practice. Companies are outsourcing more and more of their capabilities to outside experts but the importance of establishing the GMP compliance and Quality systems status of these parties has been undervalued. Many companies fail to appreciate that all their contractors, vendors and suppliers are an extension of their own company and must therefore be held to the same standard that’s expected of them. This is accomplished through effective auditing. Effective and consistent auditing assures a company’s network of external contractors and vendors is at the level of quality required. The result is not only compliance with regulations but also reduced rejects, less problems, and fewer complaints. In the end it helps assure only products of the highest quality are provided to the patient. These auditing principles are equally applicable to internal audits. This workshop will introduce students to:

• The basics of auditing
• Audit planning
• Conducting audits
• Effective auditing techniques
• Audit analysis tools
• Writing audit reports
• Audit follow-up and closure
• Examples and exercises will help to reinforce the workshop topics.

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Topics to be Covered:

• Current regulatory requirements for supplier audits
• How to write an audit procedure to cover the following items:
  • an objective,
  • audit scope,
  • an audit schedule,
  • assignment of responsibilities,
  • evaluation criteria,
  • management review of results, and
  • corrective action policies, schedules, etc.
• How to classify suppliers based on a risk assessment and nature of materials, services or components purchased.
• Review of the areas to cover (audit checklist) during a supplier audit.
• Review of activities to be performed after completion of audit such as actions taken to observations or lack of responses.
• Discuss actions to be taken when suppliers are deemed unacceptable and potential impact on other quality systems.
• Review of an actual case studies to highlight topics listed above

Question and answer period

Who Should Attend

• Manufacturing
• Validation
• Quality Unit
• Regulatory
• Engineering
• Vendors
• Management

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