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.
Upon completion of the course, participants will be equipped to:
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.
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
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
Copyright @ 2020 bluetech-media.com, All Rights Reserved,
Design & Develope by webtech.ooo