Overview:
A Validation Master Plan (VMP) is a document that outlines the strategy for validating a project in a pharmaceutical or medical device company. It defines the areas and systems that need to be validated, and provides a written program for achieving and maintaining a qualified facility.
The VMP's purpose is to ensure that validation activities are planned and executed effectively, and that they align with the company's business objectives. It also documents compliance requirements for the site and ensures that enough resources are available for validation projects
Why should you Attend:
VMP is the backbone of the company because, all the validation and qualification activities are done in line with the VMP.
The scope of the VMP should address all activities related to equipment, utilities, processes, systems, and procedures that may impact product quality at the manufacturing facility. The processes to be validated should be determined based on a documented risk assessment.
It's important to clearly spell out what and who is (and is not) in the scope so that all readers have the same understanding of the VMP's starting point and coverage.
Areas Covered in the Session:
This training session will help all the attendees to understand the brief about the Validation Master plan (VMP) requirements. The agenda for the training session is as below;
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.