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 $100 discount for each Labcompliance Audio Seminar
Currently you can order from over 80 recorded seminars, and more are
coming every month
Preview sites - to see a list of documents in
the Usersclub
View slide show about advantages
and benefits
View a word document with a
feature comparison with other services
Login (requires access
information)
Pricing and Ordering
- Price: US$ 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
For feature comparison of the Labcompliance UsersClub with other
services, click here
For a slide presentation and FAQs,
click here
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
- 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)
- 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)
- 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)
- 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)
- 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)
- We added 12 Warning Letters (W-183 to W-194)
Special offers
Ordering