Computerized Systems Validation & Data Integrity in Pharma & Biotech Videorecording

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Computerized Systems Validation & Data Integrity in Pharma & Biotech Videorecording

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Training features

Fully online

no need to travel, just sit back, relax and enjoy the learning experience

On any device

you can log in via mobile, tablet or laptop

Flexible Schedule

start when you want and follow the course at your own pace

Continuous access

you will continue to have access to the course for 3 months after completing your registration

Conveniently designed video content

the course content is divided into shorter video lectures that will allow you to increase the attention span and improve the learning experience

Full slide deck

you will be able to download the full slide deck to support your learning

Certificate of completion

upon the completion of the course you will receive the certificate of completion signed by the course leader

Course description

This course is a compilation of topics representing recent challenges related to CSV, and how CSV relates to data integrity assurance. This course is meant to be an advanced course on selected modern CSV methods with special consideration of aspects playing into today’s omnipresent challenges around data integrity.

meet the training leader
Dr. Thierry Dietrich
Founder, Owner, Management Consultant
pharm@dviser, Germany
training

Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

Computerized Systems Validation & Data Integrity in Pharma & Biotech Videorecording Videorecording online training Fleming_Agenda Cover
key training

Topics

CSV considerations around data integrity

Auditing GXP computer systems

Inspection trends around CSV and data integrity

Requirements for e-signatures/biometric signatures

Shifting to a data perspective

Data requirements for validation

Data migration and interfaces

Verification & testing methods

Iterative prototyping & agile methods

Physical & logical security

System overview document

IT incident & change management in a GXP context

Benefits of attending

Testimonials

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