Data Integrity - It's Not New and So Much More than Just Computers
Instructor:
David Husman
Product ID: 706410
Training Level: Basic to Advanced
- Duration: 60 Min
Why Should You Attend:
This webinar provides an overview of the regulations, recent regulator citations, an approach to pragmatic compliance and a list of areas to focus on to ensure your organizations have data with integrity.
Data integrity has been in the news – from issuance of new guidance, increases in citations and warning letters to a perceived emphasis on laboratories. Companies have thought – this must be new, it’s only in China and India, well it’s just in the laboratory or it’s just bad actors. This webinar shows how the focus on data integrity really is nothing new, is found all over the world from small pharma to the largest organizations and is so much more than just computer data or laboratory records.
Areas Covered in the Webinar:
- Background
- Principles
- Key Definitions
- Regulations / Guidance
- US
- EU
- Others
- Regulatory Enforcement
- Recent Trends
- Example Citations
- Pragmatic Compliance
- Governance
- Policy
- QMS
- Security Controls
- Management / Culture
- Record Management
- Paper
- Electronic
- Equipment Management
- Specific Areas of Focus
- Personnel
- Laboratory
- Facilities and Utilities
- Warehouse
- Production
- Oversight
Who Will Benefit:
- Laboratory Personnel
- Information System Management
- Quality Assurance Management
- Regulatory Affairs
- Senior Management
- Facility/Engineering
From the following industries:
- Pharma, Bio-pharma, Medical Device – all aspects from clinical to commercial.
Free Materials:
- Copy of Data integrity article
- Husman, David W and Eng, Wanda, “How to Conduct Data Integrity Investigation Interviews”, RF Today, 13 Dec 2017, Regulatory Affairs Professionals Society. http://www.raps.org
David Husman
President and Principal Consultant, David Husman Consulting LLC
More Training By Experts
- Building a Compliant Laboratory - From Foundation to Business Excellence
- Deviation Management - Why Have We Not Solved the Problem?
- Risk Management - A Process Flow Approach to Converting a Guidance into an SOP
- Change Management - Managing Effective Change and Eliminating Unwanted Changes
- Recall Management - Regulations and System Requirements
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
