ComplianceOnline, Online Event
2013-01-10
Why Should You Attend: This presentation will help you with GMP analytical laboratory audit planning, preparing the audit team and making effective use of resources-time, audit team members. Part of this webinar training will focus on what specific areas in the analytical lab and analytical documentation/data can yield support for audit findings for analytical methods-or on the contrary, this training can also help you prepare the analytical laboratory for a targeted audit. Learning Objectives: This webinar will enable the user to better understand the various phases of an audit with particular reference to the additional requirements for the audit of an analytical laboratory. There are some essential elements of an analytical audit that will be covered, which are beneficial for potential audit team members such as the technical experts, who are required for the analytical audit. This is an opportunity to go through the phases of audit activities with particular attention to the analytical laboratory. Areas Covered in the Webinar: - 21CFR211
- ICH guidelines Q1 series, Q2, Q5C
- Guidance for Industry: Analytical Procedures and Method Validation
- Potential sources of Analytical Audit templates
- Review of recent 483’s with relevance to analytical laboratory activities and expectations
- Role and responsibilities of a Lead Auditor
- Role and responsibilities of the Analytical Method Subject Matter Expert
- Key aspects of the role and key players involved in an audit-auditor and auditee perspective
- Audit preparation activities and Laboratory preparation activities
- Analytical Audit- from planning to reporting to closing
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