Labcompliance Usersclub
50 Additions in December 2009
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More than 500 documents/video clips for instant
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And the number is increasing about every month.
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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
- Members get $100 discount for each Labcompliance
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Currently you can order from over 100 recorded seminars, and more are
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- Price: US$ 379.- for 12 months (includes
Equipment Validation Master Plan)
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- Price: US$ 699.- for 24 months (includes
Equipment Validation Master Plan)
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50 Additions in December
2009
On December 15, 2009, we add(ed) 50 new documents to
the Labcompliance Usersclub Library. They include
- 13 SOPs
- 11 Examples/checklists/templates
- 7 FDA Presentations
- 9 Reference Papers and Presentations from Private
Authors
- 1 FDA Guidance
- 1 Videoclip with an FDA official
- 11 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: Development of User Requirement
Specifications for Analytical Equipment (S-628)
- SOP Procedures: and Deliverables for
Qualification of USP <1058> Instrument Categories (S-630)
- Developing and Maintenance of Test Scripts for
Analytical Systems (635)
- Example: Suggestions for USP Analytical
Instrument Categories (E-315)
- Example: Validation Report - HPLC System
(E711-11)
- USP Presentation : Analytical Instrument
Qualification According to USP 1058 (p-517)
- SOP Revalidation of Software and Computer Systems
(S-260)
- SOP Development and Use of Spreadsheets in Part
11 and GxP Environments (S-266)
- SOP Responsibilities for Computer System
Validation (S-277)
- Checklist: Cost effective Software and Computer
System Validation (E-150)
- Template and Examples: Computer System Retirement
Plan (E-173)
- Example/Template: Excel Spreadsheet Requirement
Specifiaction (E-268)
- Checklist: Computer Systems in ISO 17025
Environments (E-610)
- Performance Qualification – Chromatography Data
System (E781-09)
- Example: Computer System Validation - Policy
(K-1318)
- Presentation: Validation of Existing/Legacy
Systems (P-214)
- Computer System Incident Report (K-1361)
- SOP Revalidation of Software and Computer Systems
(S-260)
- SOP Responsibilities for Computer System
Validation (S-277)
- Presentation: IT Infrastructure and Network
Qualification (P-264)
- Computer System Incident Report (K-1361)
- SOP SOP: Internal Audits – Preparation, Conduct,
Follow-up (S-108)
- SOP Handling Out-of-Specification Results (S-115)
- SOP Archiving GLP Data and Other Documents
(S-151)
- SOP Validation of Spreadsheet Applications
(S-264)
- SOP Development and Use of Spreadsheets in Part
11 and GxP Environments (S-266)
- SOP Retention and Archiving of Electronic Records
(S-315)SOP: Development of User Requirement Specifications for
Analytical Equipment (S-628)
- SOP Procedures: and Deliverables for
Qualification of USP <1058> Instrument Categories
- (S-630)Developing and Maintenance of Test
Scripts for Analytical Systems (635)
- Example: Suggestions for USP Analytical
Instrument Categories (E-315)
- Example: Performance Qualification –
Chromatography Data System (E781-09)
- Example: Validation Report - HPLC System
(E711-11)
- Checklist: Computer Systems in ISO 17025
Environments (E-610)
- Presentation: Handling Out-of-Specification Tests
Results and Failure Investigations (P-505)
- Presentation: Quality Assurance and Compliance in
Laboratories (P-506)
- Crafting an Efficient & Cost-effective Lab
Compliance Program (P-509)
- Effective Verification of Compendial Methods
(P-518)
- FDA Presentation: Residual Solvents:
FDA-Regulatory Perspective (G-276)
- FDA Presentation: Investigating OOS Test Results
for Pharmaceutical Products (G-334)
- FDA Guide: Residual Solvents Marketed in the
United States (F-513)
- SOP Retention and Archiving of Electronic Records
(S-315)
- SOP Data Backup and Restore (S-317)
- Example: User Requirement Specifications for 21
CFR Part11 (E-307)
- Case Studies: Part 11 Implementation (E-411)
- Presentation: FDA's New Enforcement of 21 CFR
Part 11 - 2009 (P-307)
- Template: Part11 Training Accountability (K-1413)
- FDA Presentation: Part 11 -Where we were, where
we are and where we are going (G-328)
- FDA Presentation: Data Integrity and Fraud –
Another Looming Crisis? (G-330)
- Video: FDA: Part 11 Update 2009 by John Murray
(FDA Task Force Member) (V-221)
- SOP Handling Out-of-Specification Results (S-115)
- SOP Archiving GLP Data and Other Documents
(S-151)
- Checklist: FDA Inspections (E-165)
- Presentation: Writing Effective SOPs for
Regulatory Compliance (P-132)
- Presentation: Six steps to Successful FDA GMP
Inspections (P-133)
- Presentation: Towards an ASEAN Sectoral MRA on
GMP Inspection (P-160)
- Template: Training Records (K-1023)
- FDA Presentation: Pharmaceutical Ingredient
Supply Chain (G-208)
- FDAInspections Presentation: and Risk: A
Regulatory Perspective (G-219)
- FDA Presentation: cGMP Inspections (G-224)
- FDA Presentation: API Inspections (G-225)
- Writing An Effective 483 Response (G-229)
- We added 12 Warning Letters (W-213-224)
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