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Validity : 14th May'24 to 24th May'24
Stability Studies for the pharmaceuticals ICH Q1A(R2)
- 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
Overview of the webinar
The guideline defines the 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.
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 training program will primarily focus on the concept and regulatory agencies expectations with practical approach for implementation of the Stability Studies as a part of pharmaceutical quality system and inline with the ICH Q1A(R2) guidelines.
Who should attend?
- Production
- QA
- QC
- Engineering
- R&D
- Data Integrity Team
- Compliance Team
Why should you attend?
The learning objectives are firstly understanding the regulatory agencies expectations with practical approach for Stability Studies.
How Pharmaceutical organisation personnel can ensure compliance and be able to comply the requirements.
The benefits are,
The person’s understanding about Stability Studies with special focus on practical implementation approach and also updation on the revised guideline (Q1AR2)
The person working in pharmaceutical will become compliant in this major stability study requirements.
Faculty - Mr.Hitendra Kumar Shah
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, building 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.