Learn About Laboratory Investigations & Deviations





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  1. FORUM NEWS Threads / Posts  Last Post

    1. Consult this forum for the latest news concerning the askaboutValidation community.

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    2. INTRODUCTIONS

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      Welcome to the AskaboutValidation Community! Introduce yourself here so we can get to know you better.

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      • Threads: 28
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  2. GENERAL VALIDATION Threads / Posts  Last Post

    1. CLEANING VALIDATION

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      Cleaning Validation - what are your methods

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      • Threads: 617
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    2. EQUIPMENT VALIDATION

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      Equipment Validation - PLC's, SCADA's, Laboratory Equipment, Balances, pH Meters

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      • Threads: 382
      • Posts: 1,328
    3. Good Validation Practice - For Process and Equipment Systems

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      • Posts: 1,595
    4. Confused about HVAC's, post all your questions here.

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    5. Ask about validation of lab equipment and the methods used.

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      • Threads: 349
      • Posts: 1,173
    6. Process Validation

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      • Threads: 183
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    7. Applicable Regulations, Standards, and Guidelines, Planning, Design Basics

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      • Threads: 28
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    8. Assessing your suppliers is one of the key aspects of good validation practice. Post all supplier questions here.

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    9. GENERAL DISCUSSIONS

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      Anything that doesn't fit in the main forum, please post it here.

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    10. INDUSTRY NEWS

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      Discuss the latest technologies, takeovers and turn of events in the life science world.

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    11. (Regulatory Updates across globe and Quality assurance)

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  3. CSV/SOFTWARE VALIDATION/THE REGULATED CLOUD Threads / Posts  Last Post

    1. The Regulations and the Predicate Rules.

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    2. Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use

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    3. The Cloud is Coming - Are you ready to Go-Live?

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    4. What Software do you use In-House. What are the Pros and Cons

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      • Threads: 69
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    5. A Risk-Based Approach to Compliant GxP Computerized Systems

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    6. Best Practices - Worst Practices

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      • Threads: 188
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    7. A robust network is also a well designed network!

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      • Threads: 11
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    8. At the heart of SAP functionality are approximately 10,000 data tables....need to know about the validation aspect?

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      • Threads: 4
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    9. Servers are auditable components of a system, post a question to find out more!

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      • Threads: 7
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    10. Is it Software ? Is it Firmware - The Debate goes on!

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      • Threads: 42
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    11. Questions about CSV Documentation list them here.

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      • Threads: 134
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  4. GOOD MANUFACTURING PRACTICES (cGMP) Threads / Posts  Last Post

    1. CFR - Code of Federal Regulations Title 21

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    2. Anything you need to ask about the FDA.

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    3. SERIALISATION

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      All question you have related to track and trace.

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    1. Quality Management Systems - ISO 9001:2000

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    2. Use this thread to post any questions you have about calibration and metrology.

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  5. GxP & REGULATORY TOPICS Threads / Posts  Last Post

    1. GAP - Good Auditing Practice Discussion Board

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    2. GCP - Good Clinical Practice Discussion Board

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      • Threads: 28
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    3. GDP - Good Documentation Practice & Documentation Discussion Board

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      • Threads: 69
      • Posts: 336
    4. GEP - Good Engineering Practice Discussion Board

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      • Threads: 76
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    5. GLP - Good Laboratory Practice Discussion Board

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      • Threads: 66
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    6. Quality Systems Regulations - The Law.

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      • Posts: 141
    7. RISK ASSESSMENT

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      How do you Evaluate Risk?

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    8. SIX SIGMA FORUM

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      Six Sigma is a highly disciplined process that helps us focus on developing and delivering near perfect products and services

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      • Threads: 48
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  6. VALIDATION DOCUMENTATION Threads / Posts  Last Post

    1. How do you create your MVP, who reviews it, who owns it?

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    2. FAT’s and SAT’s what is the difference between both of them. What details do you put in yours?

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    3. This section has being created to discuss best practices for creating URS documents.

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    4. Functional design specifications and how to create a successful one that meets all of the URS requirements.

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    5. How do you set up your RTM documents, how long does it take you to create one from scratch? What do you trace in your RTM?

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    6. What type of checks do you include in your IQ

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    7. What type of checks do you include in your OQ

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    8. What type of checks do you include in your PQ

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    9. How do you record your deviations and discrepancies and how do you close them out?

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    10. How detailed is your summary report, what details do you include in it?

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  7. USEFUL GMP & VALIDATION STUFF Threads / Posts  Last Post

    1. Please add any useful validation definitions or acronyms that our community may find useful

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    2. TEMPLATES

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      This section is available to post any useful templates that other members may find useful in their own projects

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      • Threads: 65
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    3. This thread is specially designed for our members to upload white papers of interest.

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    4. If you have any presentations that you think would be useful to other members, please feel free to post them in this section

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      • Threads: 9
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  8. PROJECT MANAGEMENT Threads / Posts  Last Post

    1. Questions related to project delivery within the life sciences, our experts are at hand to help you.

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  9. LEARNABOUTGMP.COM Threads / Posts  Last Post

    1. All questions answered!

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    2. Articles written by our learnaboutgmp team.

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