Get 50% off with the coupon code COUPON50Bracketing and Matrixing in Pharmaceuticals
- Thursday
- August
- 14
- 2025
Hitendrakumar Shah Overview:
Bracketing and matrixing are important tools used in the pharmaceutical industry to streamline not only stability testing but is very useful in ANDA submissions and validations.
Stability testing is crucial to ensure that drug products maintain their quality, purity, and potency throughout their shelf life. However, testing every single batch of every product under all possible conditions can be time-consuming and expensive. That's where bracketing and matrixing come in.
This session will discuss in detail with scope in stability testing. Additionally, will discuss other aspects where this tool can be used.
Bracketing and matrixing are valuable tools that can help pharmaceutical companies to conduct stability testing, ANDA submissions and validations more efficiently and cost-effectively.
When used appropriately, these strategies can help to ensure the quality and safety of drug products while also saving time and resources.
Of course, the whole learning will be in line with the different current guidelines.
Why should you Attend:
The learning objectives are firstly understanding and practical implementation of bracketing and matrixing approach to ensure the quality and safety of drug products while also saving time and resources
The benefits are,
- Reduced testing time and costs with compliance
- Flexibility: Bracketing and matrixing can be adapted to a variety of situations and can be used in combination with each other
- Improved compliance level
Areas Covered in the Session:
- Brief introduction of the concept, brief strategy
- Bracketing and matrixing scope in stability study, ANDA submissions and validations
- Applicability of reduced design
- Bracketing - Design factors, strength and container closure size and/or fills
- Example for Bracketing approach
- Matrixing - Design factors, test reduction plans
- Applicability and degree of reduction
- Potential risk with Matrixing Approach
- Q&A
- Vote of Thanks and contact details
Who Will Benefit:
- Quality Assurance
- Quality Control
- Pharmaceutical IT compliance
- Global QA
- corporate QA and QC
- IT Personnel working or related to Pharma IT Support
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.