Auditing laboratory data systems
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The document provides details about a webinar led by Dr. Mark Powell, focusing on the essential auditing of laboratory data systems to meet regulatory standards. It outlines the key topics that will be covered, including data system management, integrity of analytical data, and compliance practices. The session is aimed at a variety of professionals, particularly those involved in auditing laboratory operations without a chemical background.
Auditing laboratory data systems
- 1. Auditing Laboratory Data Systems www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
- 2. Instructor Profile: Dr Mark Powell is a Fellow of the Royal Society of Chemistry (RSC) with over 20 years' experience as a senior analytical chemist. He is a member of the RSC's Analytical Division Council and chairs their working group on Continuing Professional Development. Until September 2013, he was Scientific Manager for a pharmaceutical CRO specializing in early-stage drug development. He left that job to set up Mark Powell Scientific, a company that offers training and consultancy services in analytical chemistry. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
- 3. Description: The effective auditing of laboratory data systems is essential in order to ensure that the expectations of regulatory agencies are met. This webinar will provide details of the most common non-conformances and provide staff members, who are unfamiliar with laboratory computer systems with an understanding of the controls that are necessary to ensure the integrity of analytical data. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
- 4. Objectives of the Presentation: The objectives of the presentation are to cover areas such as: Categories of laboratory data system (GAMP) Lifecycle management, archiving and backup What counts as raw data? Protecting the integrity of analytical data General guidance on assigning user privileges Operating system configuration. Application configuration Controls appropriate for chromatography data systems Practices that aid compliance with data integrity requirements Examples from recent FDA warning letters www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
- 5. Why Should you Attend? The webinar will teach participants the importance of correct data system configuration and what to look for during the audit. Businesses will benefit by reducing the risk of regulatory action as a result of failure to comply with current expectations. Who can Benefit? Staff who are required to audit analytical operations who do not have a chemical QC background. Auditors who require updating on current regulatory expectations. QC staff who needs help in regulatory compliance. Staff who would like to understand the implications of data integrity for laboratory data systems. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
- 6. Live Session - How it works? Username and Password will be sent to you 24 hours prior to the webinar Presentation handouts in pdf formate will be mailed to you Login to the session using the username and password provided to you Get answer to your queries through interactive Q&A sessions via chat Get certification of attendance. Recorded Session – How it works? A link will be provided to you upon purchase of the recorded session Please click on the link to access the session Presentation handouts in pdf formate will be mailed to you Get certification of attendance. www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
- 7. Get Connected With Us: www.onlinecompliancepanel.com www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com