Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR : 2-Day In-Person Seminar

“This education activity has been submitted to the Compliance Certification Board (CCB)® and is currently pending their review for approval of CCB CEUs.”
This highly interactive two-day course uses real life examples and explores proven techniques for reducing costs, usually by two-thirds, associated with implementing, and maintaining computer systems in regulated environments.

It details the requirements for Part 11 and Annex 11: SOPs, software product features, infrastructure qualification, and validation.
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.
Understand the specific requirements associated with local and SaaS/cloud hosting solutions.
It details the requirements for HIPAA Protect Health Information (PHI)
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.
The instructor reviews recent FDA inspection trends and discusses how to streamline document authoring, revision, review, and approval.
Participants will learn how to write a Data Privacy Statement to comply with the EU General Data Protection Regulation (GDPR).

This course benefits anyone that uses computer systems to perform their job functions and is ideal for 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.

Learning Objective:

Reduce costs, usually by two-thirds, for compliance with electronic records
Learn how to use electronic records and electronic signatures to maximize productivity
Understand what is expected in Part 11 and Annex 11 inspections so you are prepared
Avoid 483 and Warning Letters
Understand the responsibilities and specific duties of your staff including IT and QA
Understand your responsibilities and liabilities when using SaaS/cloud
Learn how HIPAA expands Part 11 compliance
Learn how to perform risk-based Computer System Validation using fill-in-the-blank templates
How to select resources and manage validation projects
"Right size" change control methods that allows quick and safe system evolution
Minimize validation documentation to reduce costs without increasing regulatory or business risk
Learn how to reduce testing time and write test cases that trace to elements of risk management
Learn how to comply with the requirements for data privacy
Learn how to buy COTS software and qualify vendors
Protect intellectual property and keep electronic records safe

Who will Benefit:

GMP, GCP, GLP, regulatory professionals
QA/QC
IT
Auditors
Managers and directors
Software vendors, SaaS hosting providers

Speaker:

David NettletonFDA Compliance Specialist, Computer System Validation

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications.
He has completed more than 230 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.

For Registration:
https://www.complianceonline.com/computer-system-validation-reduce-costs-and-avoid-483s-seminar-training-80005SEM-prdsmchannel=eventbrite

Note: Use coupon code REFERRAL10 > and get 10% off on registration.