Computer System Validation
by Amish ShahLanguages: English, Gujarati, Hindi
Price (from): €0
About the trainer:
Astute, result driven, focused and highly motivated professional and strategist with 22+ years of diversified experience in Information Technology, specialized extensive qualitative experience within the pharmaceuticals, healthcare, clinical research, life sciences and software/automation industry.
Specialist in both core and compliance field including complied infrastructure services as per global standards, compliance audits, gap analysis, risk management, quality management, data integrity, CSV, validations, data security, data backup, e-archiving, disaster planning, process excellence and various other global compliance.
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Computer System Validation by Amish Shah
About the training
The pharmaceutical industry is regulated heavily, globally and is constantly challenged by ever-evolving stringent regulations and the need to ensure compliance. Various global guidance applies to any computerised system in the life sciences industry that is used to research, automate design, testing, component, manufacturing, labelling, packaging, distribution, complaint handling or to automate any other aspect of the quality system.
Regulations state that computerized systems that generate electronic records must be properly secured and validated to prevent unauthorized access, ensure data security and prevent data corruption, loss, or falsification. The usage of computerised system along with electronic records and electronic signatures in today’s security-conscious environment is a requirement of most regulatory bodies, is commonly written into internal security and quality procedures, is used to differentiate operations and value to the marketplace and is overall good business practice.
Learning outcomes
Compliance
Proper Validation which provides complete documented evidence to suffice compliance requirement with pure integrity.
Focus
Preventing CSV outcomes that will have a negative impact on patient safety and your profitability.
Standards
Current techniques and philosophies being deployed in the pharmaceutical marketplace for product quality and audit success.
Risk
Reduces risk and liabilities to sustain in current regulated market.
Program
Computer System Validation
Main benefits
- #Wide collection of the biggest experts
- #Filters for all kinds of needs
- #User friendly platform
- #Fast and cheap
- #Highest level of proficiency
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