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An example of what is currently wrong with chemistry culture, even though it is dated. Update 2: The underlying macroeconomic cause for why professors can get away with this behavior.
Future chemistry faculty will have to be twice as smart, work with twice the efficiency, and reach the correct positions of influence if they want this type of unhealthy cultural attitudes to finally be put to rest. Update 3: This story has really struck a cord, thank you for sharing this link and supplying our first 20,000 visitor day!
Important: Warning letters should be interpreted in the context of full content. And sometimes they include good advice from the FDA not mentioned in the extract.
W-107 To download click on: W-107 W-106 W-105 W-063 This shows a complete sequence starting with a 483 (W-105) and followed by a full inspection report of the initial inspection (W-106), a Warning Letter (W-063) and the EIR of the follow-up inspection (W107).
Update 4: A transcribed letter from Robert Tjian From now on, I or someone designated by me will take attendance at group meetings starting at am.
Recorded Learning from Recent Warning Letters and 483's Related to Computer Validation and Part 11 With Case Studies to Avoid and Respond to 483's and Warning Letters Recorded Learning from Recent Warning Letters Related to Good Laboratory Practices For Preparation of FDA and International GLP Inspections Electronic Records Periodic Review and Evaluation of Computer Systems With strategies and tools for FDA and EU compliance July 28, 2011 Understanding and Implementing the New Final EU Annex 11 Learn about specific requirements and get tools for implementation Recorded Understanding and Preparing for FDA's New Part 11 Inspection Program With 10 Best Practice Guides for Easy Implementation Recorded Electronic Raw Data in Regulated Environments Definition, generation and archiving for FDA Part 11, HIPAA and SOX compliance Recorded FDA's 21 CFR Part 11 Introduction and Strategies and Tools for Implementation Recorded Cost Effective Electronic Data Archiving for FDA Compliance Understanding and Implementing the New GAMP Guide Recorded Electronic Audit Trails for FDA Compliance Requirements - Design - Implementation - Validation - Documentation Recorded FDA Compliant Electronic Records Management Recorded Using the SAFE Standard for Digital Signatures For legally enforceable IP Protection, Electronic Transactions and FDA Submissions Recorded Auditing Computer Systems for Part 11 and Annex 11 Compliance Prepare your organization for upcoming FDA and EU inspection Recorded Laboratories LABORATORIES Understanding the Updated USP Chapters 232/233 for Metal Impurities With SOPs and Case Studies for Easy Implementation Recorded Download more than 500 documents: SOPs, examples, templates, checklists, FDA waning letters, 483 inspectional observations, FDA and other official guidelines, presentations/publications from FDA personnel.
If the lab were extremely productive and everyone was totally focused on their work, I might understand the slovenliness but productivity is abysmal and if we continue along this path we will surely reach mediocrity in no time.
Finally, those of you who are “lame ducks” because you have a job and are thinking of your own nibs, so long as you are here you are still full-fledged members of this lab, which means participating in all aspects of the lab (i.e.
Robert Tjian Update 5: Erick Carreira responds in an interview with Christopher Shea from The Boston Globe, vaguely claims the letter may have been a joke (link: Chemist who ordered night and weekend work replies to critics).
Selected quote below: I wonder whether you would think it fair to be judged on the basis of a letter 14 years old, especially when the comments and rash judgments are made without knowledge of the context or the circumstances surrounding the individuals involved.
When thoroughly read this information is ideal to prepare firms for inspections.