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Two Day Course: How to be Efficient and Compliant with 21 CFR Part 11, Data integrity, and SaaS/Cloud – ResearchAndMarkets.com

The “How
to be efficient and compliant with 21 CFR Part 11, data integrity, and
SaaS/Cloud” conference has been added to ResearchAndMarkets.com’s
offering.

Course “How to be efficient and compliant with 21 CFR Part 11, data
integrity, and SaaS/Cloud” has been pre-approved by RAPS as eligible for
up to 12 credits towards a participant’s RAC recertification upon full
completion.

This interactive two-day course explores proven techniques for reducing
costs associated with implementing, using, and maintaining computer
systems in regulated environments.

Many companies are outsourcing IT resources and getting involved with
Software as a Service (SaaS) and cloud computing. These vendors are not
regulated and therefore regulated companies must ensure compliance for
both infrastructure qualification and computer system validation. It is
the regulated company that wants to avoid FDA form 483s and warning
letters. The seminar is intended for regulated companies, software
vendors, and SaaS/Cloud providers.

The instructor addresses the latest computer system industry standards
for data security, data transfer, audit trails, electronic records and
signatures, software validation, and computer system validation.

Today the FDA performs both GxP and Part 11 inspections, the Europeans
have released an updated Annex 11 regulation that expands Part 11
requirements and companies must update their systems and processes to
maintain compliance.

This seminar will help you understand the specific requirements
associated with local and SaaS/cloud hosting solutions.

Nearly every computerized system used in laboratory, clinical,
manufacturing settings and in the quality process has to be validated.

Participants learn how to decrease software implementation times and
lower costs using a 10-step risk-based approach to computer system
validation.

Finally, the instructor reviews recent FDA inspection trends and
discusses how to streamline document authoring, revision, review, and
approval.

This course benefits anyone that uses computer systems to perform their
job functions and is ideal for regulatory, clinical, and IT
professionals working in the health care, clinical trial,
biopharmaceutical, and medical device sectors. It is essential for
software vendors, auditors, and quality staff involved in GxP
applications.

Course Objectives:

For more information about this conference visit https://www.researchandmarkets.com/research/sczz2l/two_day_course?w=4

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