Stability Study in Pharmaceuticals as per ICH Q1A(R2)

This session focuses on stability data packages for new drugs for EC, Japan, and US registration, educating attendees on stability studies, storage conditions, significant changes, and cGMP compliance.
  • Wednesday
  • April
  • 02
  • 2025
08:00 AM PDT | 11:00 AM EDT
Duration: 90 Minutes
IMG Hitendrakumar Shah
Webinar Id: 60873
Live
Session
$119.00
Single Attendee
$249.00
Group Attendees
Recorded
Session
$159.00
Single Attendee
$359.00
Group Attendees
Combo
Live+Recorded
$249.00
Single Attendee
$549.00
Group Attendees

Overview:

The purpose of stability testing is to provide evidence on how the quality of a drug substance or drug product varies with time under the influence of a variety of environmental factors such as temperature, humidity, and light, and to establish a re-test period for the drug substance or a shelf life for the drug product and recommended storage conditions.

This session will focus on stability data package for a new drug substance or drug product that is sufficient for a registration application within the three regions of the EC, Japan, and the United States. 

This training session will be helpful for  all phama professionals. 

Why should you Attend:

  • Understand the brief about stability study for pharmaceuticals
  • Understand the different storage conditions and period and designing of the stability study
  • Understanding the brief about significant changes
  • Overall, for getting cGMP compliance and practicalapproach

Areas Covered in the Session:

  • Purpose
  • Guidance Requirement
  • Selection of batches, container closure system, specification
  • Testing frequency
  • Practical Approach - Protocol Preparation
  • Report Preparation
  • What is meaning of Significant Change 
  • Stability Commitment
  • Common Issues while stability study
  • Introduction to Other Stability studies - Photostability, Hold Time Studies, In-use Studies, Transport Validation

Who Will Benefit:

  • Production
  • QA
  • QC
  • Engineering
  • R&D
  • Data Integrity Team
  • Compliance Team

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.