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Usersclub

More than 400 documents/video clips for instant download.

And the number is increasing about every month. Register once and get access 24hours a day, 7 days a week. The documents include

  • FDA Warning letters, related to compliance and/or validation, to learn from mistakes others made. Keywords and sample extracts make it easy to search for selected topics.
  • FDA 483 inspectional observations, related to compliance and/or validation, otherwise difficult to get. Keywords and sample extracts make it easy to search for selected topics.
  • Example Standard operating procedures related to validation and other compliance and quality issues
  • Templates, examples, checklists that help to implement GxP regulations
  • FDA publications and presentations, some are not available otherwise on the Internet
  • Easy access to official documents from FDA and European agencies
  • Interviews with FDA representatives to learn how to interpret regulations and guidelines
  • Reference publications and presentations of compliance gurus, sometimes not (yet) published anywhere else
  • Video clips with FDA officials about FDA's drug GMP initiative, risk based inspections and the new scope of part 11
  • Members get $100 discount for each Labcompliance Audio Seminar
    Currently you can order from over 80 recorded seminars, and more are coming every month

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Pricing and Ordering

  • Price: US$ 349.- for 12 months (includes Equipment Validation Master Plan)
    VAT will be added for EU countries.
  • Ordering: (SSL secured, recommended for payment by credit card)
    - Electronically from this this web site (SSL secured)
    - Regular mail or fax using the form in PDF or MS Word format

 

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New Additions in March 2008

On March 1, 2008, we add(ed) 41 new documents to the Labcompliance Usersclub Library. They include

  • 10 SOPs
  • 11 Examples/checklists/templates
  • 2 Reference Papers
  • 5 FDA Presentations
  • 1 FDA Guidance
  • 12 FDA GxP Warning Letters/483s/EIRs

Below find the list of new documents. To easily find the documents, click on the headlines, and use the browser's search function

 

Equipment Qualification

  • SOP: Development of User Requirement Specifications for Equipment (S-246)
  • Reference Paper: Support from Instrument Vendors for Compliance (A-109)
  • Reference Paper:: (Laboratory) Equipment Qualification and Computer System Validation (A-552)
  • Example: Performance Qualification - HPLC System (E-711-09)

Computer/software validation

  • SOP: Configuration Management and Version Control of Software (S-259)
  • SOP:  Qualification of Servers (S-291)
  • SOP: Auditing Computer System (S-272)
  • Support from Instrument Vendors for Compliance (A-109)
  • Reference Paper: (Laboratory) Equipment Qualification and Computer System Validation (A-552)
  • Example: Installation Qualification - Document Management System (E-741-07)
  • Example: Requirement Specifications - Chromatography Data System (E-781-02)

Laboratory Compliance (NEW Section)

  • SOP: Change versus Adjustment of Compendial Methods (S-617)
  • SOP: Transfer of Analytical Methods (S-614)
  • Checklist: Out of Specification Situations (OOS) (E-116)
  • Gap Analysis/Checklist: Using Electronic Laboratory Notebooks in FDA Regulated Environments (E-164)
  • Checklist: System Suitability Testing (E-176)
  • Example: Requirement Specifications - Chromatography Data System (E-781-02)
  • Presentation T. Savage, US FDA: Laboratory GMPs and Inspectional Issues:
    an FDA Perspective (G-268)
  • Presentation Edwin Rivera, US FDA, Investigating OOS Test Results for Pharmaceutical Products (G-334)

(Electronic) Records/Part11

  • SOP: Recording of GCP Source Data (S-163)
  • SOP: Archiving GLP Data and Other Documents (S-151)
  • Reference Paper: Support from Instrument Vendors for Compliance (a-109)
  • Checklist: Electronic Audit Trail (E-152)
  • Checklist: Using Computerized Systems in Clinical Trials (E-154)
  • Checklist: FDA Record Retention and Retrieval (E-155)
  • Presentation George Smith, US FDA:: Current Phase of the Part 11 Proposed Amendment Process (G-333)
  • Presentation Steve Wilson, US FDA, FDA Regulatory Perspective: Data Integrity (G-332)
  • FDA Guidance: Using Electronic Means to Distribute Certain Product Information (F-441)

General Compliance/Regulatory Updates

  • SOP: International GMP Inspections: Preparation, Conduct, Follow up (S-142)
  • SOP: Handling Deviations from Standard Operating Procedures (S-106)
  • Checklist - Initial and On-going Training (E-117)
  • Gap Analysis/Checklist: Good Laboratory Practice Regulations (E-166)
  • Presentation Grace McNally, US FDA  Lifecycle Approach to Process Validation (G-245)

Warning Letters/483 Inspectional Observations/EIRs

  • We added 12 Warning Letters (W-183 to W-194)

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