URGENT PANDEMIC INFORMATION

In light of the pandemic situation events until September 2021 are cancelled. We will inform customers directly when the events are rescheduled.    
COVID CANCELLED: Project Management in Human Resources,   Boston MA, Jan 6-8, 2021
COVID CANCELLED: InterDrone, The International Drone Conference,   Cambridge MA, Jan 11-13, 2021
COVID CANCELLED: Supplier Management for Medical Device Manufacturers,   Cambridge MA, Feb 2-4, 2021
COVID CANCELLED: US Immigration Compliance Strategies,   Boston MA, Feb 15-18, 2021
COVID CANCELLED: Project Management Training,   Boston MA, Mar 3-5, 2021
COVID CANCELLED: Internal Audit, Fraud Risk Assessment Workshop,   Boston MA, Mar 22-25, 2021
COVID CANCELLED: Agile / Scrum Training,   Boston MA, Apr 12-14, 2021
COVID CANCELLED: Validation, Verification and Transfer of Analytical Methods,   Boston MA, Apr 19-21, 2021
COVID CANCELLED: Computer System Validation - Reduce Costs and Avoid 483s,   Boston MA, May 10-12, 2021
COVID CANCELLED: SharePoint Technology Conference,   Boston MA, May 26-28, 2021
COVID CANCELLED: Employment Laws Certificate Program,   Boston MA, Jun 7-9, 2021
Following events are tentatively planned but may be rescheduled, based on CDC guidelines or attendee registration interest .    
TENTATIVE: 21 CFR Part 11 Compliance,   Boston MA, Sep 22-24, 2021
TENTATIVE: Quality Control Laboratory Compliance,   Boston MA, Oct 6-8, 2021
TENTATIVE: Analytical Instrument Qualification and System Validation,   Boston MA, Nov 15-17, 2021
TENTATIVE: FDA's New Import Program for 2021,   Boston MA, Dec 7-9, 2021

Boston Professional Events List


6-Hour Webinar 21 CFR Part 11 (Electronic Records/Electronic Signatures)


Date
Aug 20, 2021 - 11:00 AM - Aug 21, 11:00 AM
Organizer
WCS
Venue
online
Location
WCS Consulting Inc.3190 Stirling Rd, Unit K4 ,Hollywood, FL 33021,

Hollywood,
FL,
US,
ZIP: 33021
Phone: 844-267-7299 | 954-947-5671  

Why should you attend

The attendee will learn how to comply with FDA's 21 CFR Part 11 guidance, which addresses the use of electronic records and electronic signatures (ER/ES). There are specific security and authentication requirements that are not necessarily covered by the standard computer system validation (CSV) approach, and go somewhat beyond this.
We will also address the roles of people involved in validating and supporting the systems, aside from just the standard system users. There are many tasks and functions they need to understand in order to be in compliance.


Who will benefit

Professionals in the following industries may also benefit from the content:
• Pharmaceutical
• Medical Diagnostics
• Biotechnology
• Tobacco and Related (Vapor, e-Cigarette, Cigar, etc.)
• Animal Health
Any other FDA-regulated industry, plus any Life Science Consulting or Contracting firm
• Information technology managers and analysts
• Production managers and analysts
• QC/QA managers and analysts
• Clinical data managers and scientists
• Compliance managers
• Lab managers and staff
• Automation analysts
• Computer system validation specialists
• GMP training specialists
• Business stakeholders and individuals who are responsible for computer system validation planning, execution, reporting, compliance, training and audit
• Consultants working in the life sciences, tobacco and related industries who are involved in computer system implementation, validation and compliance



Agenda


Agenda
Part I The Keys to COTS Computer System Validation 1 hour
  • The Keys to COTS Computer System Validation
  • “GxP” Computer Systems
  • Regulatory Oversight
  • Software Categorization
  • “COTS” Software
  • “Cloud” Solutions
  • SaaS Solutions
Part II Step-Wise Process for COTS Risk-Based Computer System Validation and Change Control 1 hour
  • Computer System Validation (CSV)
  • System Development Life Cycle (SDLC) Methodology
  • Computer System Risk Assessment
  • CSV Policies and Procedures
  • System Operations and Maintenance
  • Organizational Readiness
  • CSV Documentation
  • System and Data Governance
Break 30 min
Part III 21 CFR Part 11 Compliance hour.
  • FDA’s 21 CFR Part 11 Electronic Records and Electronic Signatures (ER/ES) Compliance
  • 21 CFR Part 11 Overview
  • 21 CFR Part 11 Compliance
Part IV Purchasing COTS Software 1 hour
  • Vendor Audit Background
  • Vendor Audit Strategy and Planning
  • Vendor Audit Execution
  • Validation Strategy
  • Validation Components
Part V Industry Best Practices 1 hour
  • FDA Inspection Trends
  • Industry Trends - Deficiencies
  • Industry Best Practices
Wrap-Up Session
Q&A 30 mins
 


Speaker Details


Faculty:

Carolyn Troiano has more than 35 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries.

Wcs Seminars
Registration Details
(Contact us : 844-267-7299 | 954-947-5671  
Don't wait. Register TODAY or  Email  US [email protected]


Event Categories
Keywords: pharmaceutical




Comments








Events Calendar

SunMonTueWedThuFriSat
1 2 3 4 5 6 7
8 9 10 11 12 13 14
15 16 17 18 19 20 21
22 23 24 25 26 27 28
29 30 31 1 2 3 4

Newsletters

VIP Life Time Subscription to our Newsletters!
$399.99
$299.99