Overview:
The customer and regulatory agencies expectations are very clear. The product should be of consistent quality. The process validation is a tool which ensures the product is of consistent quality.
However, to reach the expectations of regulatory agencies and customers, we can not just depend on the traditional/initial/prospective validation.
As per the FDA expectations, “An ongoing program to collect and analyze product and process data that relate to product quality must be established (§ 211.180(e)).
This training program will primarily focus on the concept and regulatory agencies expectations with practical approach for implementation of the continued process verification as a part of process validation life cycle approach.
Why you should Attend:
The learning objectives are firstly understanding the regulatory agencies expectations with practical approach for implementation of the continued process verification as a part of process validation life cycle approach.
How Pharmaceutical organization personnel can ensure compliance and be able to comply the requirements.
The benefits are:
Areas Covered in the Session:
The major points covered include
Who Will Benefit:
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.