Live Webinar Good Documentation Practice (GDP)

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Live interactive and instructor led

Abstract:

Health Canada, FDA and other regulatory agencies all require companies to demonstrate compliance in most areas of their businesses. To demonstrate compliance, documented evidence is required as proof. In the past, many audit findings are a result of lack of proper documentation.

Good documentation practice is necessary, not only for regulators, for various aspects of a regulated company’s operations:

• Investigation
• Audits
• Traceability
• Continuous improvement
• Complaint or recalls
• Packaging records
• Manufacturing records
• Laboratory records

This webinar provides attendees with in-depth understanding of the requirements for Good Documentation Practice (GDP) in a GPP or GMP environment.

Course Outline

• Importance of Good Documentation Practice (GDP)
• Applications and regulations in Pharmaceutical, Cannabis and Food industries
• 9 Simple Rules for Good Documentation Practice + ALCOA
• Proper procedure for corrections
• Handling of errors: dates, raw data, late entries and more
• Proper template design to avoid common GDP errors

This course will deliver the tools to enable you to:

• Understand best practices related to Good Documentation system
• Develop a consistent documentation system in your organization
• Review and audit for non-compliant documentation

Note: Course outline is subject to change without notice. Please check back regularly for updates.

Who Should Attend

Industry professionals including employers, management team, employees who are interested maintaining documentation compliance in accordance to GMP, GPP and ISO.

 Certificate of Attendance and Course Material

• All participants will receive a certificate of attendance upon completion of the course.
• The participants will be receiving specially prepared course manual.