Change Control - A Practical and Compliance View

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This Free Learning Session will help you all to learn many things about Change Control.
• Do you want to learn the PDCA cycle during the change control process?
• Do you want to learn QRM during the change control process?
• Do you want to learn the categorization of changes based on the Heat Matrix?
• Do you want to learn the change control process scope for the cGXP computerized system?
• Do you want to learn about the future role of Artificial Intelligence in change controls?
• Do you want to know about the life cycle approach of change controls?
• Do you want to know common errors related to change controls? If the answer to any of the above question/s is "YES", the designed training session is for you.
#pharmaceutical #capa #compliance #regulatoryaffairs #automation
Join this channel to get access to the perks:
/ @hitendrakumarshah3718
This session will help you learn many aspects of the Change Control Process-
ABrief introduction of the concept
Know your Trainer
Need for Change Control
Guideline expectations about Change Controls- EU,FDA, ICH, PIC/S, ISO etc.
Detailed understanding of Change Control Life cycle
PDCA Cycle in relation to Change controls
Types of change controls - Categorization using Heat Matrix
Artificial Intelligence - Scope in Change Control
cGXP Computerized systems - Scope in Change Control
What is normally missing in Change Controls
Q&A session
Link for QRM - ICH Q1A(R2) - • Quality Risk Managemen...
Link for QRM - Basics - • Quality Risk Management

[@Chikuonline]

Please explains change control risk assessment, impact assessment and action items for change in excipient, API vendor
Change in equipment
Change in area
Change in location / site
Introducing new product
Change in batch size
Change in software

[@aravindsharma4216]

Sir for what type of change controls require effectiveness check verification

[@hitendrakumarshah3718]

All changes required to evaluate effectiveness

[@srinivasulubhavanasi2734]

Please share PPT sir

[@hitendrakumarshah3718]

You can join online LIVE training session. The sessions are arranged on every Saturday at 20:00 Hrs (IST). During this session, I am sharing PPT. After that, I will not have the PPT. As, this session is very old, I am not having it. If you have any technical question/or need any clarification, please share your thoughts. Thanks.