ICH Q10 - Pharmaceutical Quality System

This training session emphasizes the significance of quality system inspections and the life cycle approach in pharmaceutical quality systems, highlighting the need for effective implementation in many companies.
IMG Hitendrakumar Shah
Webinar Id: 60177
Recorded
Session
$159.00
Single Attendee
$359.00
Group Attendees

Overview:

During any inspection, the inspection of the quality system is mandatory for all inspectors. Many companies even do not know about the quality system objectives. The objective needs to focus are, achieve Product Realization, Establish and Maintain a State of Control and Facilitate Continual Improvement.

Further for all activities like validation, qualification, documentation etc., the life cycle approach is very important. Many companies fail to comply the life cycle approach requirements.

This training will focus on all these aspects including quality system elements and life cycle goals.

Why you should Attend:

Many companies failed to comply the requirements. Some of the requirements and detailed below.

  • Systems for inspection and role of PQS in inspections
  • Pharmaceutical quality system objectives
  • Pharmaceutical quality system Goals
  • Life Cycle Approach
  • Elements of PQS
  • Trending and evaluation of trends

Areas Covered in the Session:

This training session will help all the attendees to understand the brief about the Pharmaceutical quality system requirements. The agenda for the training session is as below; 

  • Importance of topic and Agenda
  • Know your Trainer
  • Understanding the different guidelines 
  • ICH Q10 Objectives 
  • Life Cycle Approach 
  • Trending and evaluation of the trends
  • Management Responsibility 
  • Elements of Pharmaceutical Quality System 
  • Key message 
  • Q&A
  • Vote of Thanks and contact details

Who Will Benefit:

  • Quality Assurance
  • Quality Control
  • Pharmaceutical Compliance
  • Global QA
  • Corporate QA and QC

Speaker Profile

Hitendrakumar Shah is a Quality oriented professional with over 23 years of experience in Quality Assurance, Quality Control, Quality engineering, Quality auditor, pharmaceutical regulations and regulatory audit compliance.

The area of expertise is as per the requirement of USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO & Schedule-M Guidelines. The key competencies include, Quality Compliance, Supplier Audit, build systems to encourage compliance with the principles of data integrity, computer system validation, Training, Risk assessment, Facing the audits, preparation and review of audit compliance, Qualification & validation, system development for CAPA effectiveness, stability studies & solving preapproval or post approval queries raised by regulatory agencies etc.

Independently handled - Quality assurance and Quality Control department for more than 13 years.

Audits faced- USFDA (8 times), ANVISA, MHRA, MCC, TGA,IDMA excellence, WHO audit, EU regulatory (9 times) , Yemen MOH, Digemid (Peru), Russian Authority audit etc.

Analytical Background: The analytical background includes, physical, chemical, microbiological testing of raw material, finished product & Stability samples. Handled the chromatographic instruments - HPLC, GC, FTIR, UV Visible spectrophotometer, AAS etc.