Description
This course will make you understand about different aspects of good laboratory practices. The first aspect will include data integrity in analytical laboratory and Microbiolgy laboratory. This will mainly focus on FDA/EU Citations, Non IT – Focus area for data integrity, IT- Focus area for data integrity, Some examples of data integrity, Current trends of inspectors, Data integrity in Microbiology laboratories – Some examples etc. Furthermore, attendees will learn about 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 and many more.
Requirements
The attendees should learn in focused way and while learning, care should be taken not get disturbed and if required, while learning, the attendee can take notes.
Further this good laboratory practices session will take you through analytical method validations, stability studies, out of specification and out of trend investigations and the most common problems solving in analytical laboratories. The analytical method validation comprises of FDA expectations about analytical method, Brief on QBD approach, How practically approach for validation, Role of QRM in analytical method validation, Brief information on ICHQ14 – Analytical method development, Detailed on ICHQ2(R1) – Analytical method validation, Understanding of all validation parameters, Overall evaluation and Revalidation criteria
The most common problem in analytical laboratories is human error investigation. Many errors are identified as human errors. This course is having specific one lecture which will focus on learning about different types of human errors and how to investigate and avoid the human errors.
Who this course is for?
This Training Course will benefit all who are working in pharmaceutical industries. Those who are auditors, participating in validation, quality control, production, compliance and ensure process and product improvement etc. QA/ QC Regulatory Affairs Project Managers Validation personnel Compliance personnel Auditors Personnel involved in QMS
