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50 New Usersclub Additions

- 18 SOPs
- 12 Examples/Checklists
- 5 Forms/Templates
- 2 Master Plans/Primers
- 3 FDA Presentations
- 10 Warning Letters

 

Online Audio Seminars come with 10+ Best Practice guides for easy implementation

 

Configuration Management and Change Control for Networks and Computer Systems

Changes of Hardware, Firmware, Software, Networks, Documentation

May 24, 2012

 

Validation and Use of Excel® Spreadsheets in Regulated Environments

Comply with Part 11, QSR, and Annex 11.

June 21, 2012

 

Selecting Acceptance Criteria for Regulatory Method Validation

Learn through case studies and get inspection ready documentation

July 10, 2012

 

Qualification and Use of Virtual Networks in Regulated Environments

With Strategies and Tool Kit for Compliance and System Uptime

July 12, 2012

 

Implementing the New USP Chapters 232/233 for Elemental Impurities

Learn how to comply with FDA, USP and ICH Requirements

July 26, 2012

 

Verification of Compendial Methods according to the New USP Chapter <1226>
Understand the new risk based approach and  get real world case studies for testing
Recorded, available at any time

 

How to Prepare Yourself for FDA's on-going Part 11 Inspection Program

Learn what the FDA is looking for and how to respond

Recorded

 

Validation of Bioanalytical Methods and Procedures

Conduct and Document for Efficiency and FDA&EMA Compliance

Recorded, available at any time

 

Raw Data in FDA Regulated Environments

FDA/EU compliant recording, maintenance and archiving

Recorded

 

Learning from Recent Warning Letters Related to GMP Laboratory Controls

For Preparation of FDA and International GMP Laboratory Inspections

Recorded, available at any time

 

Development and Validation of Stability Indicating Methods for FDA/ICH Compliance

Sample generation - method development - validation - documentation

Recorded, available at any time

 

FDA Compliant Use of (Certified) Reference Material

With 10+ Best Practices for easy Implementation

Recorded

 

Analytical Instrument Qualification According to USP <1058>

With SOPs, Templates and Examples for Easy Implementation

Recorded

 

 

with 10+ validation  examples, seminar with FDA's Dennis Cantellops and Ludwig Huber and with 13 SOPs for easy implementation.

 

 

Labcompliance News May 2012

USP Chapters <232/233> for Elemental Impurities Approved

General Chapters <232> and <233> were approved for publication in the Second Supplement to USP 35 published June 1, 2012, with an official date of December 1, 2012. The new chapters will be mandatory on May 1, 2014, when the current chapter <231> "Heavy Metals" will be obsolete. The removal of all references to chapter <231> from monographs will be announced through a General Notice provision. Attend the Labcompliance audio seminar to learn everything about elemental impurities according to USP chapters and receive 10 best practice guides for easy implementation. For more information see the USP update on Elemental Impurities

FDA Warning letter: Paper print-outs of e-records incomplete, missing e-audit trail, no back-up of raw data

The warning letter was received by a pharmaceutical manufacturer. Primary deviations included: no back-up of raw data, printed copies of e-records do not include all raw data and metadata, e.g., no instrument control parameters, no security control of electronic data, SOP does not include provisions for audit trail reviews. Other violations included: No or inadequate procedures to prevent microbilogical contamination, no risk assessment of the impact of no cleaning validation. The company had responded to all related 483 observations, but most responses have been inadequate for a variety of reasons. The Warning Letter can be downloaded from the Labcompliance Usersclub. Scroll down to W-273. Non members can preview excerpts. Attend the Labcompliance audio seminar to learn everything about FDA compliant sampling and sample handling

EMA Releases Quality Guideline Concerning Biological Investigational Medicinal Products

The guidance sets out the requirements related to an investigational medicinal product (IMP) to be submitted with the request for a clinical trial authorization.  The guidance applies to proteins and polypeptides, their derivatives, and products of which they are components (e.g. conjugates). These proteins and polypeptides are
produced from recombinant or non-recombinant cell-culture expression systems and can be highly purified and characterized using an appropriate set of analytical procedures. The principles may also apply to other product types such as proteins and polypeptides isolated from tissues and body fluids. The new guideline is available on the EMA website.

New Version 3.0 of the ISO 17025 Accreditation Package Released

On May 07 Labcompliance has released a new major revision of the popular ISO 17025 Accreditation package. The new version includes 11 new SOPs, an updated quality manual,  an updated step-by-step implementation plan, a new time table and tool kit for estimating costs and timing for implementation. In addition most other key documents have been updated to reflect most recent recommendations from official accreditation committees and laboratory quality system experts. With the new additions the package includes 49 SOPs for chemical testing and 38 SOPs for mechanical, optical and electronic testing and calibration laboratories.  For additional information and ordering, click here.

'Advice' from FDA on Using Excel in Regulated Environments

Excel is frequently used in laboratories, offices and manufacturing as sophisticated  calculator.  Some companies stay away from using Excel and other spreadsheets in FDA regulated because such Out-off-the-Box software does not comply with all FDA requirements. Therefore some companies stay away from using Excel in GxP environments. However, with the necessary controls Excel can be brought into compliance. For example, the FDA has developed two internal Information Bulletins on developing and using spreadsheets in regulated environments. Useful advice also is received from FDA inspection reports. To learn everything about how FDA is using Excel in their own regulated environments and about current  regulatory expectations for using Excel, and to receive two FDA Spreadsheet Information Bulletins click here.

Japan Applies for PIC/S Membership

On 9 March 2012 Japan's Ministry of Health, Labour and Welfare (MHLW) applied in its name as well as on behalf of the Pharmaceuticals and Medical Devices Agency (PMDA) and the Japanese Prefectures for PIC/S membership. Reference: PIC/S News

Free Document of the Month

As a 'Thank You' for our visitors Labcompliance offers every month one document for free. This month's document is the Best Practice Document "SOP: Subcontracting of Testing and Calibration". To download your free copy, go to the ISO 17025 Accreditation Package website.. Scroll down and click on the corresponding ICON on the left (offer expires on May 31, 2012). Labcompliance offers more than 130 SOPs and other documents that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here

Audio Seminar Schedule

 

  1. Configuration Management and Change Control for Networks and Computer Systems
    Changes of Hardware, Firmware, Software, Networks, Documentation
    May 24, 2012
  2. Validation and Use of Excel Spreadsheets in Regulated Environments
    Comply with FDAs Part 11 and Quality System Regulation (QSR) and with the EU Annex 11
    June 21, 2012
  3. Selecting Acceptance Criteria for Regulatory Method Validation
    Learn through case studies and get inspection ready documentation
    July 10, 2012
  4. Qualification and Use of Virtual Networks in Regulated Environments
    With Strategies and Tool Kit for Compliance and System Uptime
    July 12, 2012
  5. Implementing the New USP Chapters 232/233 for Elemental Impurities
    Learn how to comply with FDA, USP and ICH Requirements
    July 26, 2012

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