REDUCE COSTS FOR COMPLIANCE WITH DATA INTEGRITY: 21 CFR Part 11,
SaaS/Cloud, EU GDPR *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT
CARD! ***REGISTER TODAY! 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). Seminar Fee
Includes:LunchAM-PM Tea/CoffeeSeminar MaterialUSB with seminar
presentationHard copy of presentationAttendance Certificate$100 Gift
Cert for next seminar 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 AGENDA
Day 01(8:00 AM - 5:00 PM) 08.00 AM - 08.30 AM: Registration 08.30 AM:
Session Start Introduction to the FDA (1 hr) How the regulations help
your company to be successful Which data and systems are subject to
Part 11. 21 CFR Part 11/Annex 11 - COMPLIANCE FOR ELECTRONIC RECORDS
AND SIGNATURES (4 hr) What Part 11 means to you, not just what it says
in the regulations Avoid 483 and Warning Letters Explore the four
primary areas of Part 11 COMPLIANCE: SOPs, software product features,
infrastructure qualification, and validation documentation How
SaaS/cloud computing changes qualification and validation Ensure data
INTEGRITY, security, and protect intellectual property Understand the
current computer system industry standards for security, data
transfer, and audit trails Electronic signatures, digital pens, and
biometric signatures SOPs required for the IT infrastructure Product
features to look for when purchasing COTS software REDUCE VALIDATION
RESOURCES BY USING EASY TO UNDERSTAND FILL-in-the-blank validation
documents. HIPAA COMPLIANCE FOR ELECTRONIC RECORDS (30 Min) How Part
11 and HIPAA interrelate What are the additional requirements for
patient data The Five Keys to COTS Computer System Validation (30 Min)
The Who, What, Where, When, and Why of CSV The Validation Team (30
Min) How to select team members How to facilitate a validation project
Day 02(9:00 AM - 3:30 PM) Ten-Step Process for COTS Risk-Based
Computer System Validation (1 hr) Learn which documents the FDA
expects to audit. How to use the risk-based validation approach to
lower COSTS. How to link requirements, specifications, risk
management, and testing. Document a computer system validation project
using easy to understand fill-in-the-blank templates. Based on:
"Risk-Based Software Validation - Ten Easy Steps" (Davis Horwood
International and PDA - www.pda.org, 2006). How to Write Requirements
and Specifications (30 Min) Workshop for writing requirements and then
expanding them for specifications How to Conduct a Hazard
Analysis/Risk Assessment-Exercise (30 Min) Step-by-step instructions
for performing and documenting a risk assessment, and how to use the
results to REDUCE VALIDATION DOCUMENTATION. Software Testing (1 hr)
REDUCE TESTING BY WRITING TEST CASES THAT TRACE TO ELEMENTS OF RISK
MANAGEMENT. How to write efficient test cases How to write a Data
Privacy Statement (30 Min) How to meet the requirements of the EU GDPR
Purchasing COTS Software (30 Min) How to purchase COTS software and
evaluate software vendors Cost Reduction Without Increasing Regulatory
or Business Risk (1 hr) How to save money How to increase quality How
to increase COMPLIANCE WITH LESS DOCUMENTATION 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. Please contact the
community manager Marilyn (marilyn.b.turner@nyeventslist.com ) below
for: - Multiple participant discounts- Price quotations or visa
invitation letters- Payment by alternate channels (PayPal, check,
Western Union, wire transfers etc)- Event sponsorshipsNO REFUNDS
ALLOWED ON REGISTRATIONSService fees included in this
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28/02/2020 Last update