Labcompliance Usersclub
50 Additions in November 2011
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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
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- Price: US$ 379.- for 12 months (includes
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50 Additions in November
2011
On November 1, 2011, 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
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- We added 10 Warning
Letters (W-247-257)
73 Previous
Additions in 2011
On March 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
- 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)
- 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)
- 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)
- 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)
- 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)
- 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)
- We added 22 Warning
Letters (W-225-246)
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