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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McVay, 30, helped direct a Redskins unit that finished this season ranked third in the NFL in total offense, averaging 403.4 yards per game, and 12th in scoring at 24.8 points per outing. The Redskins ranked 17th the season before in yards per game (353.8) and 10th in scoring (24.2). Mike Jones, The Washington Post More Redskins: Washington announced it has signed nine players to reserve/future contracts: defensive lineman A.J. Francis (Maryland), wide receiver Matt Hazel, linebacker Rufus Johnson, defensive lineman Joey Mbu, offensive lineman Ronald Patrick, defensive back Shak Randolph, tight end Wes Saxton, wide receiver Kendal Thompson and offensive tackle Isaiah Williams. Et cetera Read the story Lacrosse: Former Maryland midfielder Taylor Cummings edged teammate Kayla Treanor by just 20 votes to claim the Inside Lacrosse Division I Player of the Year Award, decided by an online poll. Terps defender Alice Mercer received 4.172 percent of the vote to finish fifth. Treanor, who plays for the Boston Storm, was named the United Women’s Lacrosse League Player of the Year. Baltimore Ride attacker Dana Dobbie, a former Maryland player, now a Loyola Maryland assistant, received 18.151 percent of the vote to finish third. McDonogh’s Chris Robinson finished fourth with 12.55 percent of the vote for the women’s Coach of the Year award.
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To be more specific, you should follow this advice: 1. Dark shoes which you have polished 4. Limited jewellery such as one wedding ring 4. Use this kind of products lightly. It should be noted that being rejected once does not bare one s chances of being selected to a different job position. Answers should be precise and to the point. 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. A few words about Hygiene: To look clean and fresh is also very important! why not try these out