PERSONNEL TRAINING IN BIOANALYSIS DR. SHIVPRAKASH MANAGING DIRECTOR SYNCHRON RESEARCH SERVICES PVT. LTD., INDIA

WHOM WE ARE TRAINING? If you pay peanuts then you will get only monkeys. Like King, Like people. Training is an attitude building. Can create world class managers only through proper training.

PERSONAL TRAINING IN BIO-ANALYTICS Bio-Analytical Clinical Research Pre-Clinical research GCP & GLP GLP

WE ARE INTERESTED IN CLINICAL RESEARCH Training is a requirement of both GCP & GLP Adequate qualification of people is important to meet business and regulatory requirements Training can close the gap between actual qualifications and requirement of assigned jobs. People working in regulated environments receive adequate training and the training is documented for compliance and regulations. Training must be formally planned and documented. New objectives and activities (includes new SOPs) always involves some training. Training systems are usually SOP based.

TRAINING SYSTEM Formal Approved Documented to standard format. Described in a SOP Historical reconstruction should be possible through the archive.

AREAS OF TRAINING GCP (National and ICH Guidelines) GLP (OECD) 21 CFR Part 11 & Computer system validations. SOPs USFDA Guidelines for method validation USFDA Compliance program guidance manual No (In vivo Bioequivalence studies) Sample analysis.

TRAINING REQUIREMENTS OF MANAGEMENT IN BIO-ANALYTICAL LAB. GCP/GLP regulations and compliance. Electronic Records – Electronic Signatures – 21 CFR Part 11. Computer System Validations.

GCP/GLP REGULATIONS AND COMPLIANCE Applications of GCP/GLP regulations - purpose of regulations. Key requirements and what they mean for the Company. Status of implementations. Consequences of non-compliance. Responsibilities.

ELECTRONIC RECORDS – ELECTRONIC SIGNATURES – 21 CFR PART 11 Purpose History Benefits for the company Key requirements and what they mean for the company Meaning of Electronic Signatures Regulatory enforcements practices Consequences of non-compliance. Company’s implementation plant Responsibilities.

COMPUTER SYSTEM VALIDATIONS The company’s approach to computer validation. Resources and Costs for computer validation. Consequence of Non-compliances. Responsibilities.

TRAINING REQUIREMENT FOR EMPLOYEES GCP/GLP Regulations and Compliance Purpose Key requirements. How to behave during inspections. FDA enforcement.

COMPUTER VALIDATION Regulations and guidelines as applicable to the job. Concept of software development life cycle. The company’s approach to computer validation The company’s validation master plan Content of project plan DQ/IQ/OQ/PQ Writing specifications Vendor assessment. Acceptance testing. Configuration management and change control Control of validation report. Responsibilities

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