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Labcompliance Usersclub

62 New Additions on September 12, 2016

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More than 500 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 100 recorded seminars, and more are coming every month

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Pricing and Ordering

  • Price: US$ 379.- for 12 months (includes Equipment Validation Master Plan)
    VAT will be added for EU countries.
  • Price: US$ 699.- for 24 months (includes Equipment Validation Master Plan)
    VAT will be added for EU countries.
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    or MS Word format

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On September 12, 2016, we added 62 New Documents to the Labcompliance Usersclub Library. They include

  • 19 SOPs !!!
  • 21 Examples/checklists !!!
  • 8 Forms/templates
  • 2 Master Plans/Primers
  • 12 selected GxP FDA 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: Calibration and Qualification of Stability Chambers (S-652)
  • Example: Validation Plan HPLC System (E711-01)
  • Example: Requirement Specifications SFC System (E-716-02)
  • Form: Verification of Proper Installation for ASTM E2500 (K-1257)
  • Form: Equipment List (K-3521)

Computer/Software Validation

  • SOP: Developing a Gap Analysis for Software and Computer System Validation (S-249)
  • SOP: Periodic Evaluation and Review of Computerized Systems (S-258)
  • SOP: Using Macros and Spreadsheets (M&S) in a Regulated Environment (S-265)
  • SOP: Validation of Electronic Laboratory Notebooks (S-267)
  • SOP: Auditing Laboratory Computer Systems for Data Integrity (S-272-02)
  • SOP: Handling Security Patches (S-288)
  • Checklist: EU/PICS GMP Annex 11: Version 2011 (E-151)
  • Checklist: User Requirement Specifications for Computer Systems (E-153)
  • Checklist: Network Infrastructure Qualification and System Validation (E-157)
  • Checklist: Retrospective Validation of Computer Systems (E-159)
  • Checklist: Software/Computer System Vendor Assessment (E-321)
  • Checklist: Using Computer Systems in ISO 17025 Environments (E-610)
  • Example: Requirement Specifications - Document Management System (741-02)
  • Example: Chromatography Data System - Validation Project Plan (E-781-01)
  • Form: Computer System Validation Deliverables (K-1323)
  • Master Plan / Examples: Retirement Plan for Computer Systems (M-176)

Network Qualification

  • SOP: Change Control for Networks and Systems - Planned Changes (S-283)
  • SOP: Handling Security Patches (S-288)
  • Checklist: EU/PICS GMP Annex 11: Version 2011 (E-151)
  • Checklist: Network Infrastructure Qualification and System Validation (E-157)

Laboratory Compliance

  • SOP: Generation and Maintenance of SOPs (S-104)
  • SOP: Handling Out-of-trend Situations (S-116)
  • SOP: Training for GLP Compliance (S-123)
  • SOP: Using Macros and Spreadsheets (M&S) in a Regulated Environment (S-265)
  • SOP: Validation of Electronic Laboratory Notebooks (S-267)
  • SOP: Scanning of Paper Records for ISO 17025 Compliant Archiving (316-02)
  • SOP: Providing Services to Customers (S-524)
  • SOP: Preparation of Laboratory Working Standards (S-532)
  • SOP: Reserve Samples in Laboratories (S-535)
  • SOP: Measurement Uncertainty in Chemical Analysis (S-536)
  • SOP Manual Reintegration of Chromatographic Peaks (S-552
  • SOP: Validation of HPLC Methods (S-611)
  • SOP: Validation of Stability Indicating Methods (S-619)
  • Checklist: Verification of Compendial Methods (E-174)
  • Checklist; ISO 17025 (E-178)
  • Checklist: Pharmaceutical Analytical Laboratory QA Audit (E-184-05)
  • Case Studies: How to Respond to 483s and Warning Letters Related to OOS and Failure Investigations (E-417)
  • Example: Chromatography Data System - Validation Project Plan (E-781-01)
  • Form: Project Plan for ISO 17025 (K-1545)
  • Form: Justification and Documentation of System Risk for
    Laboratory Systems (K1691)
  • Form: ISO 17025 Laboratory Management Review (K-3517)
  • Master Plan / Examples; Analytical Methods Transfer Master Plan and Examples (M-185)

(Electronic) Records/Part11

  • SOP: Auditing Laboratory Computer Systems for Data Integrity (S-272-02)
  • SOP: Scanning of Paper Records for ISO 17025 Compliant Archiving (S-316-02)
  • SOP: Security and Integrity of Electronic Laboratory Data (S-551)
  • SOP Manual Reintegration of Chromatographic Peaks (S-552)
  • Checklist: EU/PICS GMP Annex 11: Version 2011 (E-151)
  • Case Studies: How to Respond to Data Integrity related 483's and Warning Letters (E-425-02
  • Case Studies: How to Avoid Data Integrity Related 483's and Warning Letters (426-02)
  • Form: 21 CFR PART 11 Project Team (K-1411)

General Compliance/Regulatory Updates

  • SOP: Handling Out-of-trend Situations (S-116)
  • SOP: Training for GLP Compliance (S-123)
  • SOP: Security and Integrity of Electronic Laboratory Data (S-551)
  • SOP Manual Reintegration of Chromatographic Peaks (S-552)
  • Checklist: ISO 17025 (E-178)
  • Case Studies: How to Respond to 483s and Warning Letters Related to OOS and Failure Investigations (E-417)
  • Case Studies: How to Respond to GLP Related 483's and Warning Letters (E-428)
  • Checklist: Using Computer Systems in ISO 17025 Environments (E-610)
  • Checklist: Elemental Impurity Control according to ICH Q3D (E-611-01)
  • Form: Project Plan for ISO 17025 (K-1545)
  • Form: Risk Categories Based on Compliance Impact (K-4033)

Warning Letters/483 Inspectional Observations/EIRs

  • We added 12 new FDA Warning Letters (W-291-303)

On December 1, 2014, we added 71 New Documents

We added 71 new documents to the Labcompliance Usersclub Library. They include

  • 20 SOPs !!!
  • 23 Examples/checklists
  • 7 Forms/templates
  • 4 Master Plans/Primers
  • 4 Reference Papers
  • 13 selected GxP FDA 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

  • Reference Paper: Qualification of High-Performance Liquid Chromatography Systems (A-553)
  • Checklist: Validation and Qualification According to the EU-GMP Annex 15-2014 (E-151-04)
  • Form: – Reporting Test Deviations (K-3304)
  • SOP Handling Deviations during Equipment and Computer System Testing (S-238)

Computer/Software Validation

  • Reference Paper: Validation of Spreadsheet Applications (A-263)
  • Reference Paper: Qualification and Validation of Software and Computer Systems in Laboratories -Part 3. - Installation and Operational Qualification (A-558)
  • Checklist: Using Macros and Spreadsheets in a Regulated Environment (E-156)
  • Checklist; Using Computers in FDA Regulated Environments (E-161)
  • Master Plan/Examples: Retirement Plan for Computer Systems (E-239)
  • Case Studies How Much Validation is Enough? (E-454)
  • Form: Documenting Training – Computer Validation (K-1313)
  • Form: Documenting Deviations of Computer System Reviews (K-1359)
  • Form: Documenting Corrective Actions of Computer System Reviews (K-1360)
  • Form: – Reporting Test Deviations (K-3304)
  • SOP Handling Deviations during Equipment and Computer System Testing (S-238)

Network Qualification

  • Case Studies How Much Validation is Enough? (E-454)
  • Form: – Reporting Test Deviations (K-3304)
  • SOP Handling Deviations during Equipment and Computer System Testing (S-238)

Laboratory Compliance

  • Reference Paper: Qualification of High-Performance Liquid Chromatography Systems (A-553)
  • Reference Paper: Qualification and Validation of Software and Computer Systems in Laboratories -Part 3. - Installation and Operational Qualification (A-558)
  • Checklist: Using Macros and Spreadsheets in a Regulated Environment (E-156)
  • Checklist: Validation of Analytical Methods according to the FDA Guidance 2014 (E-171-02)
  • Checklist: Review of Analytical Methods and Procedures (E-171-03)
  • Worksheet: Auditing Quality Control Laboratories(E-184-03)
  • Checklist: Measurement Traceability in Chemical Analysis (E-187)
  • Example: List with Required Laboratory Records for ISO 17025 (E-199)
  • Checklist Elemental Impurity Analysis According to USP <232/233> (E-611)
  • Example: Installation Qualification HPLC System (E-711-07)
  • Example: Test Sheet and Approvals HPLC System (E-711-12)
  • Example: Design Qualification SFC System (E-716-05)
  • Example: Validation Report SFC System (E-716-11)
  • Example: Risk Assessment Stability Chambers (E-721-03)
  • Example: Method Validation Report Assay of Drug Substances in Drug Products by HPLC (E-731-34)
  • Example: Requirement Specifications Spreadsheet Applications (E-745-02
  • Example: Installation Qualification - Chromatography Data System (E-781-07)
  • Reporting Analytical Results with Expanded Uncertainty (K-1664)
  • Master plan/Examples: Development and Validation of Analytical Methods through QbD (M-190)
  • SOP Setting up a Quality System for Pharmaceutical Testing Laboratories(S-503)
  • SOP Internal Audits for ISO 17025 (S-507)
  • SOP Conducting Laboratory Management Reviews (S-510)
  • SOP Auditing Quality Control Laboratories (S-511-03)
  • SOP Review and Approval of Analytical Test Results (S-512)
  • SOP Identification and Control of Laboratory Records (S-526)
  • SOP Measurement Traceability in Chemical Analysis (S-537)
  • SOP Review of Analytical Methods and Procedures (S-605-02)
  • SOP Calibration and Qualification of Stability Chambers (S-652)

(Electronic) Records/Part11

  • Worksheet: Comparison 21 CFR Part 11 - China GMP (E-168-01 )
  • Case Studies: Electronic Audit Trail (E-415)
  • Example: Letter to the FDA About Electronic Signature Certification (K-1412)
  • Primer: 21 CFR Part 11 – Electronic Records and Electronic Signatures (M-214)
  • SOP Recording of GCP Source Data (S-163)
  • SOP Testing File Integrity of E-Mail Attachments (S-248)

General Compliance/Regulatory Updates

  • Reference Paper How to set Up A CAPA Program From Scratch (A-124)
  • Checklist: Pharmaceutical Quality Systems in Testing Laboratories (E-120)
  • Case Studies: How to Avoid and Respond to Training Related 483s and Warning Letters (E-430-01)
  • Worksheet: Assessment of Potential Genotoxic Impurities (E-620)
  • Form/Example Vertical Audit (K-1112)
  • Master plan/Examples: Building a GLP Laboratory (M-135)
  • Primer: Risk Management in the (Bio)Pharmaceutical and Device Industry (M-241)
  • SOP: Document Management and Control (S-105)
  • SOP: Writing and Distribution of Electronic SOPs (S-107)
  • SOP  Investigating Manufacturing Incidents (S-118)
  • SOP Going from GLP to GMP (S-120-01)
  • SOP Building a GMP System for International Environments (S-126)
  • SOP Auditing Suppliers (S-128)
  • SOP Requirements, Responsibilities and Tasks of the Qualified Person (S-145)
  • SOP Historical SOP File for GLP Regulations (S-150
  • SOP Elemental Impurity Control According to ICH Q3D (S-416)

Warning Letters/483 Inspectional Observations/EIRs

  • We added 13 new FDA Warning Letters (W-279-291)

56 New Additions in the last 12 months, Last update September 2013

We added 56 new documents to the Labcompliance Usersclub Library. They include

  • 15 SOPs !!!
  • 10 Examples/checklists
  • 3 Forms/templates
  • 7 FDA Presentations
  • 13 selected GxP FDA 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

  • Example: Checklist: Implementing ASTM E2500 (E-141):
  • Example:  Supplier Assessment According to ASTM E2500 (E-320)
  • Form: Identification of Subject Matter Experts for ASTM E2500 (K-1252)
  • Form: Justification and Documentation of System Risk for ASTM E2500
    (K-1255)
  • Form: Verification Plan for ASTM E2500 (K-1258)

Computer/Software Validation

  • SOP: Using Cloud Computing in Regulated Environments (S-293)
  • Checklist: Revalidation of Computer Systems (E-148)
  • Checklist: Using Electronic Signatures in Regulated Environments (E-152-01)
  • Case Study: How Much Validation is Enough? (E-454)
  • Example: Document Management System - Step-by-Step Validation (E-741-00)
  • Example: Document Management System - Validation Plan (E-741-01)
  • Example: Document Management System - Validation Report (E-741-11)

Network Qualification

  • SOP: Qualification of Virtual Networks (S-292)
  • Testing of Authorized System Access (E-362)

Laboratory Compliance

  • SOP: Auditing Laboratories for ISO 17025 Compliance (S-511-02)
  • SOP: Purchasing of Services for Laboratories (S-514-02)
  • SOP: Quality Assessment of Laboratory Service Providers (515-02)
  • SOP: Laboratory Complaint Handling for ISO 17025 (S-520-01)
  • SOP: Improving the Effectiveness of the Laboratory Management System (S-520-11)
  • SOP: Laboratory Facilities and Environmental Control (S-520-16)
  • SOP: Selection of Analytical Methods and Procedures (S-605)
  • SOP: Development and Validation of Analytical Methods through Quality by Design (S-609)
  • SOP: Retrospective Validation of Laboratory Computer Systems (S-663)
  • FDA Presentation: An FDA - CBER Regulatory Perspective on Analytical Procedures and Method Validation (G-429)

(Electronic) Records/Part11

  • SOP: Review of Electronic Audit Trail (S-323)
  • SOP: Integrity and Security of Electronic Records (S-324)
  • SOP: Using Electronic Signatures in Regulated Environments (S-325)
  • Checklist: Using Electronic Signatures in Regulated Environments (E-152-01)
  • Example: User Requirement Specifications for Electronic Signatures (E-307-01)

General Compliance/Regulatory Updates

  • Handling Deviations from Standard Operating Procedures (S-106)
  • FDA Presentation: Implementing Quality by Design (2007) (G-251)
  • FDA Presentation: Update on Implementing Quality by Design (2009) (G-252)
  • FDA Presentation, Mr. Camelo Rosa, Current International Compliance Issues, Changing to a Culture of Quality (G-250)
  • FDA Presentation, Ms. Susan Laska, FDA’s Foreign Inspection Program (G-249)
  • FDA Presentation: Inspection Update 2012 (G-252)
  • 2012 Update on FDA Inspections and Product Recalls (G-253)

Warning Letters/483 Inspectional Observations/EIRs

  • We added 13 new FDA Warning Letters (W-279-291)

50 New Additions (Nov 2012)

We added 50 new documents to the Labcompliance Usersclub Library. They include

  • 18 SOPs !!!
  • 12 Examples/checklists
  • 2 Primer /Implementation Plan
  • 5 Forms/templates
  • 3 FDA Presentations
  • 10 selected GxP FDA 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: Auditing a Supplier’s Equipment Master Validation Plan (S-231-01)
  • SOP: Developing an effective Supplier Program to Assist Regulated Users (S-251-01)
  • SOP: Selecting the Right Software and Equipment Supplier for Compliance (S-251-02)
  • SOP: Qualification of Analytical Equipment (S-632)
  • SOP: Requalification of Analytical Equipment (S-633)
  • Checklist: What Regulated Users should expect from Suppliers of Equipment and Computer Systems (E-148-06)
  • Checklist: What Equipment and Computer System Suppliers should offer to Regulated Users (E-148-07)
  • Template and Examples: Supplier Quality Agreement /E-149-01)

Computer/Software Validation

  • SOP: Auditing a Supplier’s Equipment Master Validation Plan (S-231-01)
  • SOP: Developing an effective Supplier Program to Assists Regulated Users (S-251-01)
  • SOP: Selecting the Right Software and Equipment Supplier for Compliance (S-251-02)
  • Periodic Evaluation and Review of Computerized Systems (S-258)
  • SOP: Retirement of Computer Systems (S-261)
  • SOP: Retrospective Validation of Computerized Systems (S-269)
  • Checklist: Periodic Evaluation and Review of Computerized Systems (E-148-01)
  • Checklist: What Regulated Users should expect from Suppliers of Equipment and Computer Systems (E-148-06)
  • Checklist: What Equipment and Computer System Suppliers should offer to Regulated Users (E-148-07)
  • Template and Examples: Supplier Quality Agreement /E-149-01)
  • Examples: Useful Excel Functions and VBA Code to Improve Quality and Compliance of Workbooks (E-131)

Network Qualification

  • Primer: Qualification of Networks and Validation of Networked Systems,
    41 Pages (M-212)
  • SOP:  Risk Based Qualification of Network Infrastructure (S-285)
  • SOP:  Using Internet in FDA Regulated Environments (S-287)
  • SOP: Selecting the Right Software and Equipment Supplier for Compliance (S-251-02)
  • SOP: Periodic Evaluation and Review of Computerized Systems (S-258)
  • SOP: Retirement of Computer Systems (S-261)

Laboratory Compliance

  • SOP: Corrective and Preventive Actions (S-114)
  • SOP: Out-of-Specification Data Trending (S-117)
  • SOP: Training for GLP Compliance (S-123)
  • SOP: Laboratory Complaint Handling (S-520)
  • SOP: Handling of Laboratory Test Samples (S-534)
  • SOP: Qualification of Analytical Equipment (S-632)
  • SOP: Requalification of Analytical Equipment (S-633)
  • Checklist: Security and Integrity of Electronic Data in Laboratories  (E-148-03)
  • Case Study: Matrixing and Bracketing in Stability Studies (E-431)
    Case Study: Verification of Compendial Procedures (E-450-01)
  • Checklist: Compliance for Biopharmaceutical Laboratories  (E-616-01)
  • Example Validation Report:: Assay of Drug Substances in Drug Products by HPLC (E-731-34)
  • Example: Step-by-Step Validation - Chromatography Data System (E-781-00)
  • Form: Documenting Corrective Actions (K-3511)
  • Form: Documenting Preventive Actions (K-3512)

(Electronic) Records/Part11

  • SOP:Electronic Audit Trail: Specifications, Implementation and Validation (S-322)
  • Checklist: Security and Integrity of Electronic Data in Laboratories  (E-148-03)
  • Example: Requirement Specifications for Electronic Audit Trail (E-258)
  • Example: Implementing 21 CFR Part 11 - Step by Step (M-513)
  • Case Study: How to Respond to Data Integrity and Security Related FDA Observations (E-420-01)
  • FDA Presentation: Part 11 Inspection ‘Add-On’ Results June 21, 2011 (G-338)
  • Example:  Letter to the FDA About Electronic Signatures (K-1412)
  • Example: Part 11 Objectives - (K-1416)

General Compliance/Regulatory Updates

  • SOP: Corrective and Preventive Actions (S-114)
  • SOP: Out-of-Specification Data Trending (S-117)
  • SOP: Training for GLP Compliance (S-123)
  • SOP: Auditing Suppliers (S-128)
  • SOP: Risk Assessment for Systems Used in GxP Environments (S-134)
  • Example: Risk Categories Based on Business Impact (K-4034)
  • FDA Presentation: FDA Foreign Inspection Results, 2010 (G-249)
  • FDA Presentation:  Regulatory Trends in Aseptic Processing, With a summary of CGMP Deficiencies Cited During FDA International Inspections in 2010, (G-278)
  • Form: Documenting Corrective Actions (K-3511)
  • Form: Documenting Preventive Actions (K-3512)

Warning Letters/483 Inspectional Observations/EIRs

  • We added 10 Warning Letters (W-247-257)

73 Previous Additions in 2011

On November 10, 2011, we added 73 new documents to the Labcompliance Usersclub Library. They include

  • 14 SOPs
  • 20 Examples/checklists
  • 3 Master Plans/Primers
  • 2 Expert Presentations
  • 10 Forms/templates
  • 3 FDA Presentations
  • 22 FDA selected 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: Supplier Assessment According to ASTM E2500 (S-236)
  • SOP: Change Control of Equipment (S-242)
  • SOP: Requalification of Equipment (S-244)
  • SOP: Allocating Analytical Instruments to USP <1058> Categories (S-629)
  • Example: Supplier Assessment - HPLC System (E-711-04)
  • Example: Qualification Plan - Stability Chambers (E-721-01)
  • Example: Supplier Assessment - Stability Chambers (721-04)
  • Example: Performance Qualification - Stability Chambers (721-09)
  • Form: Equipment Identification and Location (K-1212)
  • Form: Project Schedule - ASTM E2500 (K-1251)
  • Form: Documenting Vendor Assessment for ASTM E2500 (K-1256)
  • Example: Equipment Records (K-3520)

Computer/software validation

  • SOP: Supplier Assessment According to ASTM E2500 (S-236)
  • SOP: Development of Requirement Specifications for Computer Systems
    (S-253)
  • SOP: Using Macros and Spreadsheets in a Regulated Environment (265)
  • SOP: Auditing Computer Systems (S-272)
  • SOP: Disaster Recovery of Computer Systems (S-319)
  • Checklist: EU GMP Annex 11: Version 2011 (E-151)
  • Gap Analysis/Checklist: Laboratory Computer Systems (E-158)
  • Example: Test Plan - Document Management System (E-741-06)
  • Example: Step-by-Step Validation - Spreadsheet Applications (E-745-00)
  • Example: Validation Project Plan - Spreadsheet Applications (E-745-01)
  • Example: Test Plan - Spreadsheet Applications (E-745-06)
  • Example: Supplier Assessment - Chromatography Data System (781-04)
  • Example: Vision for Computer System Validation (K-1315)
  • Form: Computer Incident Form (K-1361)
  • Example: Documenting Computer System Validation Audits (K-1366)
  • Template/example: Identification of Projects with Highest Potential for Cost Savings (K-1372)
  • References: 33 Computer and Software Clauses in ISO 17025 - And recommendations for Implementation (R-201)

Network Qualification

  • SOP: Development of Requirement Specifications for Computer Systems
    (S-253)
  • SOP: Auditing Computer Systems (S-272)
  • SOP: Qualification of Data Centers (S-290)
  • SOP: Disaster Recovery of Computer Systems (S-319)
  • Form: Computer Incident Form (K1361)

Laboratory Compliance

  • SOP: Using Macros and Spreadsheets in a Regulated Environment (S-265)
  • SOP: Allocating Analytical Instruments to USP <1058> Categories (S-629)
  • SOP: Performance Testing of Stability Chambers (S-653)
  • FDA Presentation: Analytical Method Transfer, with three Case Studies (G-426)
  • Checklist:  Shelf Life Testing for Drugs and Drug Substances (E-135)
  • Gap Analysis/Checklist: Laboratory Computer Systems (E-158)
  • Checklist: Measurement Uncertainty in Chemical Analysis (E-186)
  • Example: List with Required Laboratory Records for ISO 17025 (E-199)
  • Case Studies: Risk Based Methodologies for Laboratory Tasks (E-453)
  • Example: Supplier Assessment - HPLC System (E-711-04)
  • Example: Qualification Plan - Stability Chambers (E-721-01)
  • Example: Supplier Assessment - Stability Chambers (E-721-04)
  • Example: Performance Qualification - Stability Chambers (E-721-09)
  • Template/Examples: Validation Plan - Validation of HPLC Methods (E-731-21)
  • Example: Supplier Assessment - Chromatography Data System (E-781-04)
  • Form: Horizontal Laboratory Audit (K-1111)
  • Master Plan: Stability Studies for Drugs and Drug Substances (M-168)
  • References: 33 Computer and Software Clauses in ISO 17025 - And recommendations for Implementation (R-201)

(Electronic) Records/Part11

  • SOP: Archiving and Retrieval of GCP Data and Other Documents Retention
     
    (S-164)
  • Checklist: EU GMP Annex 11: Version 2011 (E-151)
  • Case Studies: How to Avoid Part11 Related 483's and Warning Letters (E-426)
  • Example: Vision - Electronic Records & Electronic Signatures (K-1415)
  • Example: Implementing Electronic Records & Electronic Signatures and 21 CFR Part 11 Compliance (K-1417)
  • Example: Equipment Records (K-3520)
  • Master Plan: 21 CFR Part 11 Compliance (M-132)
  • Presentation: How to Prepare Yourself for FDA's New Part 11 Inspection Program, Learn what the FDA is looking for and how to respond (P-310)
  • Presentation: Understanding FDA's 21 CFR Part 11: Introduction and Strategies and Tools for Implementation (P-311)
  • FDA Presentation: CDER Part 11 Inspection Assignments 2011 (G-337)

General Compliance/Regulatory Updates

  • SOP: Internal Audits for Part 111 Compliance, Preparation - Conduct - Follow-up (S-109)
  • SOP: Training for GMP Compliance (S-124)
  • SOP: Responding to FDA Warning Letters (S-144)
  • SOP: Archiving and Retrieval of GCP Data and Other Documents Retention
     
    (S-164
  • Case Studies: FDA Inspection for 21 CFR Part 111: Without 483 Observations(E-421)
  • Case Studies: How to Respond to GLP Related 483's and Warning Letters (E-428)
  • FDA Presentation: International Inspection Results 2010 (G.-278)
  • Primer: FDA Inspections Survival Guide (M-222)

Warning Letters/483 Inspectional Observations/EIRs

  • We added 22 Warning Letters (W-225-246)

 

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