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Validity : 10th Sep'24 to 20th Sep'24
Data Integrity for Microbiology laboratories
- Know your Trainer
- Different guidelines on Data Integrity
- Evaluation of FDA warning letter and assessment
- Understanding ALCOA+ concept
- Common examples of data integrity
- Audit Trail in Microbiology
- Sterility Test – When we can repeat
- Q&A
- Vote of Thanks and contact details
Overview of the webinar
Data integrity observations are of paramount importance. Because the observations are categorized as Major in nature. This training will help to understand microbiology laboratory personnel, chemist, reviewers, and the personnel related to the laboratory department (QA, QC, development, RA) to ensure compliance.
Who should attend?
- Production
- QA
- QC
- Engineering
- R&D
- Data Integrity Team
- Compliance Team
Why should you attend?
Data integrity observations are of paramount importance. Because the observations are categorized as Major in nature.
Also, the remediation of these observations is quite tough. As per the MHRA guide on data integrity – “Data Governance systems should include staff training in the importance of data integrity principles and the creation of a working environment that enables visibility, and actively encourages reporting of errors, omissions and undesirable results”. So, this training will play a very important role in compliance with the requirements.
Faculty - Mr.Hitendra Kumar Shah
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, building 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.