Cleaning Validation Practical
Implementation and Compliance Approach

Date 29th & 30th October 2021

Training @ Hyderabad​

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About The Workshop

As, we are all aware that, cross contamination is considered as critical because, it is directly linked to the patient safety. This training course will provide insight to attendees for practical implementation of cleaning validation and evaluate existing cleaning validation philosophy in line with regulatory requirements. This training course provides practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. The course will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, cleaning SOPs and other appropriate documentation. In addition, participants will understand the requirements for maintaining a validated cleaning process.

Benefits of attending

Upon completion of the course, participants will be equipped to:

  • How the worst case limit or product identified theoretically can be evaluated practically & how to handle practical problems faced during developing cleaning validation.
  • Outline the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product.
  • Understand the FDA & other regulatory agencies perspectives, evaluate current loose threads on cleaning validation and areas of concern during regulatory inspections and become prepared to justify your own cleaning validation approach/ program so as to avoid high cost investment, time delays and /or adverse actions by regulatory agencies.
  • Easy pragmatic ways for developing protocol report complying to different GMP regulations.

Course Director​

HITENDRAKUMAR SHAH

Member of American Society for Quality & Indian Pharmaceutical Association.

A Quality oriented professional with over 2 decades 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, PIC/S, 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, Training, Risk assessment, Facing the audits, readiness for audit, review of audit compliance, Qualification & validation, system development for CAPA effectiveness, stability studies & solving preapproval or post approval queries raised by regulatory agencies etc.

  • Quality Independently handled assurance and Quality Control department for more than 13 years. Audits faced with Zero or Minor observations only : USFDA (5 times), ANVISA, MHRA, MCC, TGA,IDMA excellence, WHO audit, EU regulatory (5 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, IR, UV, Visible spectrophotometer, AAS etc.
  • Major GMP software used : Lab solution software, Empower 3 software, LIMS, TRIMS, Document Management system & Track wise During tenure audited more than 500 vendors/suppliers and trained more than 3000 candidates. Member of American Society for Quality & Indian Pharmaceutical Association.
  • Last Associations : Sun Pharma, alembic , Blue cross, Zydus Cadila, Titan Pharma, USV, AstraZeneca, Sanofi

Who should Attend​

Engineering, Manufacturing, validation, quality control and assurance, technology transfer and those taking care of Process validation; Cleaning validation and qualification activities of equipment and instrument facility. Research and development (R&D) of API and formulation. 

Those planning to engage in the export market and who wish to achieve cGMP compliance would also benefit from this workshop  professionals with intermediate level experience in
manufacturing.

This workshop is also suitable for those involved in pharmaceutical manufacturing in India actively engaged in the Pharmaceutical markets, this course add significant value and best compliance to the following professionals

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    Standard Fees

    Rs. 25,000/- + GST​

    Early Bird Price Rs. 22,000/-
    Valid till 15th October 2021

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