“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
[https://www.complianceonline.com/computer-system-validation-reduce-costs-and-avoid-483s-seminar-training-80005SEM-prdsm?channel=eventbrite]
Note: Use coupon code REFERRAL10 > and get 10% off on registration.
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28/02/2020 Last update