When do you get it and what kind of exposure is it? Imagine that you find a lamp that gives you three wishes? Remember you want to make yourself stand out in a positive light against the hundreds of other applicants they will be interviewing. From an academic standpoint, I have always worked hard at school primarily because I love to learn. There are always two ways that a question is answered in an interview: one is your manner, the other is your words. By knowing the specifics about the medical school at which you are interviewing and asking perceptive questions that you would like to have answered shows that you have an interest in that school. Which life would you save? Give an example of a leadership role you have assumed.
This 2-day course provides the regulatory background and guides attendees through the complete equipment qualification, calibration and computer system validation processes from planning to reporting. It also helps to fully understand Part 11 and Annex 11 requirements to ensure and document integrity and other requirements for electronic records and signatures. Analytical equipment should be qualified and computer systems should be validated to demonstrate suitability for the intended use. Electronic records must comply with FDA Part 11 and EU/PICS GMP Annex 11 requirements to ensure data integrity, security and availability. Recent EU and FDA inspection documents prove that qualification, validation and electronic laboratory are records are on target of inspectors. The large number of warning letters issued to laboratories also demonstrate that they struggle with either understanding or implementing the regulations. Learning Objectives: – Learn about the regulatory background and requirements for equipment qualification according to USP and computer system validation according to GAMP Guides – Be able to explain the difference between equipment calibration, qualification and system validation – Learn which equipment/systems need to be qualified or validated – Be able to allocate equipment and systems to USP and GAMP categories and to design and execute qualification/validation protocols accordingly – Understand the logic and principles of instrument qualification and system validation from planning to reporting – Be able to explain your company’s qualification and validation strategies – Understand how to archive raw data from hybrid systems: electronic vs. paper – Be able to define and demonstrate Part 11 compliance functionality to auditors and inspectors – Be able to develop inspection ready documentation during on-going routine operation – Learn how to ensure, document and audit integrity of raw data and other records For more information about this conference visit http://www.researchandmarkets.com/research/x2mmhp/analytical Contacts
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Always know something about a company before trying to work there. Look into what the company is all about. Make sure that you fully understand the company’s mission. Make sure employers realize that you have researched the company.
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