URGENT PANDEMIC INFORMATION

In light of the pandemic situation all of our 2021 events 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


2021 90 mins. Webinar Effective Change Control Programs


Date
Jun 15, 2021 - 01:00 PM - Jun 16, 01:00 PM
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  


Overview
Regulatory agencies require pharmaceutical and medical device companies to have a systematic approach to managing all changes made to a facility, their product or a quality system. Given the fact that changes are inevitable, it is essential that companies have a compliant and effective change control program to ensure that no unnecessary or cGMP non-compliant changes occur. This Change Control training course will discuss regulatory expectations from the FDA, EU and ICH perspective, review all the required components of a thorough Change Control program; as well as, discuss the elements regarding successful management an effective Change Control system.


Session Highlights
Topic 1: Regulatory Guidance Review
  • FDA (CFR)
  • EU (EurdraLex)
  • ICH Q10
Topic 2: Review all Elements of a Change Control Record
  • Discuss the importance of utilizing Subject Matter Experts from multiple functional areas to ensure proper evaluation, approval and implementation of proposed changes.
  • Ensure changes do not negatively impact the business or established marketing authorization.
  • How to incorporate a Quality risk based approach to evaluating proposed changes
  • Ensure changes are implemented in a timely manner by effective use of the Change Control Review Board (CCRB) and Quality Metrics
  • Understand what steps should be taken post implementation to confirm the objectives were achieved

     
Why should you attend
At the completion of this course, attendees will be able to:
  • Interpret the requirements of the FDA, EU and ICH guidelines regarding compliant Change Control records.
  • Understand all the required components of a thorough Change Control record.
  • Understand all the elements of effective Change Control management:
  • How to develop a cross-functional team to ensure proper evaluation, approval and implementation of proposed changes.
  • Ensure changes do not negatively impact the business or established marketing authorization.
  • How to incorporate a Quality risk based approach to evaluating proposed changes
  • Ensure changes are implemented in a timely manner by effective use of the Change Control Review Board (CCRB) and Quality Metrics
  • Understand what steps should be taken post implementation to confirm the objectives were achieved
Who will benefit
  • Operations employees that participate in Manufacturing
  • Engineering
  • Validation
  • Quality Assurance and Regulatory Affairs as part of their job function – includes employees in the following departments:
  • Production
  • Engineering & Validation
  • Facilities / Maintenance
  • Quality Assurance
  • Regulatory Affairs



Speaker Details


Speaker

Ms. Thomas has over two decades of cGMP hands-on industry experience in both pharmaceutical and medical device manufacturing operations. 


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




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