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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Im a huge believer in being optimistic and getting a fresh start, Carlson said Tuesday when asked about her New Year’s resolution. She also revealed a new position with Time Magazine to serve as a columnist with a focus on women and empowerment issues. Get the factsCarlson had not been seen on the air since her Fox News exit, outside of a November interview with ABCs “20/20. WikiLeaks founder: Obama admin… Julian Assange says it’s “impossible” to know if WikiLeaks influenced the… or pay big border tax!” he tweeted. President-elect Donald Trump on Tuesday morning criticized House… OPINION | The amendment strengthens the mission of the OCCR, restores… Proposal puts Office of Congressional Ethics under jurisdiction of… Speaker Paul Ryan (R-Wis.) defended the House GOPs decision to weaken its…
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A two piece matched light coloured suit is the safest choice for women 2. Usually, after the job interview, the applier is given a date when they could look to hear from the employer. In this letter, one should thank the interviewers for their time and also state the post for which one is applying. USP a marketing concept stands for unique selling proposition; a candidate USP will create a distinct image of the candidate in the mind of the interviewer which will distinguish him from the rest of the candidate. Some typical questions which are generally asked are: describe yourself, why do you want to join our company, how do you handle stress, are you a teamman, what is a your expected salary, why should we hire you, what is your work ethics, what is your dream job, why did you leave your previous job, describe about your previous work, do you have any question to ask and so on. Furthermore, one should thank the employer for considering him/her for the particular job position. Continue ReadingIf you want more information about job interview, please visit my website. It should be noted that being rejected once does not bare one s chances of being selected to a different job position. And that is that you should check the dress code of the company that you are going to have an interview with, before actually going to the interview.
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