The webinar will teach participants the importance of correct data system configuration and what to look for during the audit.

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