Train Your Staff in Good Manufacturing Practices (cGMP)





AskaboutValidation forum

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  1. GENERAL VALIDATION Threads / Posts  Last Post

    1. CLEANING VALIDATION

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      Cleaning Validation - what are your methods

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      • Threads: 605
      • Posts: 2,196
    2. EQUIPMENT VALIDATION

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

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      • Threads: 372
      • Posts: 1,302
    3. Good Validation Practice - For Process and Equipment Systems

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      • Threads: 426
      • Posts: 1,583
    4. HVAC VALIDATION

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      Confused about HVAC's, post all your questions here.

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      • Threads: 71
      • Posts: 248
    5. Ask about validation of lab equipment and the methods used.

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      • Threads: 338
      • Posts: 1,158
    6. PROCESS VALIDATION

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      Process Validation

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      • Threads: 172
      • Posts: 490
    7. Applicable Regulations, Standards, and Guidelines, Planning, Design Basics

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      • Threads: 26
      • Posts: 58
    8. RISK ASSESSMENT

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      How do you Evaluate Risk?

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      • Threads: 56
      • Posts: 212
    9. Assessing your suppliers is one of the key aspects of good validation practice. Post all supplier questions here.

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      • Threads: 8
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    10. 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: 46
      • Posts: 141
    11. GENERAL DISCUSSIONS

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

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      • Threads: 368
      • Posts: 1,058
    12. INDUSTRY NEWS

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

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      • Threads: 269
      • Posts: 279
    13. (Regulatory Updates across globe and Quality assurance)

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      • Threads: 169
      • Posts: 200
  2. CSV/SOFTWARE VALIDATION/THE REGULATED CLOUD Threads / Posts  Last Post

    1. 21 CFR PART 11

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      The Regulations and the Predicate Rules.

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      • Threads: 125
      • Posts: 485
    2. Volume 4 Good Manufacturing Practice Medicinal Products for Human and Veterinary Use

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      • Threads: 1
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    3. The Cloud is Coming - Are you ready to Go-Live?

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      • Threads: 5
      • Posts: 18
    4. COMPLIANCE SOFTWARE

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

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      • Threads: 69
      • Posts: 248
    5. A Risk-Based Approach to Compliant GxP Computerized Systems

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      • Threads: 8
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    6. Best Practices - Worst Practices

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      • Threads: 187
      • Posts: 618
    7. NETWORK QUALIFICATION

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      A robust network is also a well designed network!

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      • Threads: 11
      • Posts: 34
    8. SAP VALIDATION

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      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
      • Posts: 45
    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. SCADA & PLC's

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      Is it Software ? Is it Firmware - The Debate goes on!

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      • Threads: 42
      • Posts: 166
    11. Questions about CSV Documentation list them here.

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      • Threads: 134
      • Posts: 493
  3. GOOD MANUFACTURING PRACTICES (cGMP) Threads / Posts  Last Post

    1. CFR - Code of Federal Regulations Title 21

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      • Threads: 351
      • Posts: 1,076
    2. Anything you need to ask about the FDA.

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      • Threads: 20
      • Posts: 38
    3. SERIALISATION

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      All question you have related to track and trace.

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      • Threads: 1
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    1. Quality Management Systems - ISO 9001:2000

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      • Threads: 49
      • Posts: 194
    2. Use this thread to post any questions you have about calibration and metrology.

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      • Threads: 22
      • Posts: 63
  4. GxP & REGULATORY TOPICS Threads / Posts  Last Post

    1. GAP - Good Auditing Practice Discussion Board

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      • Threads: 34
      • Posts: 122
    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: 66
      • Posts: 323
    4. GEP - Good Engineering Practice Discussion Board

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      • Threads: 76
      • Posts: 262
    5. GLP - Good Laboratory Practice Discussion Board

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      • Threads: 66
      • Posts: 214
    6. Quality Systems Regulations - The Law.

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      • Threads: 43
      • Posts: 141
  5. VALIDATION DOCUMENTATION Threads / Posts  Last Post

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

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      • Threads: 23
      • Posts: 70
    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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      • Threads: 9
      • Posts: 43
    3. This section has being created to discuss best practices for creating URS documents.

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      • Threads: 28
      • Posts: 87
    4. Functional design specifications and how to create a successful one that meets all of the URS requirements.

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      • Threads: 4
      • Posts: 19
    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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      • Threads: 4
      • Posts: 24
    6. What type of checks do you include in your IQ

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      • Threads: 31
      • Posts: 98
    7. What type of checks do you include in your OQ

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      • Threads: 31
      • Posts: 98
    8. What type of checks do you include in your PQ

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      • Threads: 88
      • Posts: 321
    9. How do you record your deviations and discrepancies and how do you close them out?

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      • Threads: 24
      • Posts: 118
    10. How detailed is your summary report, what details do you include in it?

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      • Threads: 6
      • Posts: 21
  6. 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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      • Threads: 79
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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
      • Posts: 221
    3. WHITE PAPERS

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      This thread is specially designed for our members to upload white papers of interest.

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      • Threads: 79
      • Posts: 147
    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
      • Posts: 28
  7. 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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      • Threads: 2
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  8. LEARNABOUTGMP.COM Threads / Posts  Last Post

    1. All questions answered!

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      • Threads: 15
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    2. AUTHOR ARTICLES

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      Articles written by our learnaboutgmp team.

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      • Threads: 2
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  9. FORUM NEWS Threads / Posts  Last Post

    1. 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: 27
      • Posts: 54
    2. NEWS & ANNOUNCEMENTS

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

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      • Threads: 53
      • Posts: 115

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