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

 

FDA Compliant SFC Qualification and Performance Testing

Learn how to select, conduct and document the right tests in the right sequence

January 12, 2012

 

Quality by Design (QbD) for  Development and Validation of Analytical Methods
Learn how to design robustness for easy transfer and to avoid OOS situations
January 26, 2012

 

Qualification of Virtual Networks and Cloud Computing

With Strategies and Tool Kit for Compliance and System Uptime
February 9, 2012

Recorded

 

How to get the most out of Supplier Support  for Equipment and Computer Validation

Strategies for suppliers to maximize business and for users to minimize validation cost

Recorded

 

Cost Effective Computer System Validation: Step-by-Step

With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation

December 1, 2011

 

Validation of Analytical Methods and Procedures

Design, Conduct and Document for Efficiency and FDA Compliance

December 13, 2011

 

FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control

With Strategies and best Practice Guides for easy Implementation

December 20

 

Transfer of Analytical Procedures According to the New USP Chapter <1224>

With SOPs, templates and examples for easy implementation

Recorded, available at any time

 

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

 

Validation and Use of Excel® Spreadsheets in Regulated Environments

Comply with Part 11, PIC/S and Annex 11.

Recorded

 

Periodic Review and Evaluation of Computer Systems

With strategies and tools for FDA and EU compliance

Recorded

 

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

 

Effective HPLC Method Development and Validation

Preparation, conduct and documentation for FDA/EMA Compliance

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, October 2011

Device Manufacturer Cited for not Having Supplier Quality Agreements

A device manufacturer received a warning letter from the FDA because there were no purchasing control procedures and quality agreements with suppliers of critical items. In addition there were no specifications for incoming items. Furthermore the company implemented design changes but these changes have not been validated. Furthermore the company was cited for inadequate software validation, quality policy was not not implemented, and the water purification system was not validated, The Warning Letter can be downloaded from the Labcompliance Usersclub. Scroll down to W-257. Non members can preview excerpts. To learn more about ideal relationships between user firms and suppliers and how both sites can benefit, attend the audio seminar  "Supplier Support for Equipment and Computer Validation".

EMA Guideline on Bioanalytical Methods Validation Effective by Feb 1, 2012

Bioanalytical methods are used for measurement of drug concentrations in biological matrices (such as serum, plasma, blood, urine, and saliva) during drug development. This guideline defines key elements necessary for the validation of bioanalytical methods. It focuses on the validation of the bioanalytical methods generating quantitative concentration data used for pharmacokinetic and toxicokinetic parameter determinations. Guidance and criteria are given on the application of these validated methods in the routine analysis of study samples from animal and human studies, The new guidance can be downloaded from the EMA website.

FDA requires formal Stability Assessment of In-house Prepared Standard Solutions used for Quantitative Analysis

On a regular basis FDA answers frequently asked questions related to GMP on the FDA website.  The most recent discussion went around assessment of expiry dates of chemicals such as calibration standards, reagents, solutions, and solvents. For example, for purchased chemical FDA recommends to follow the manufacturer’s suggested "use by" or expiry date. For in-house prepared 'non-quantitative' solutions such as mobile phases FDA expects a formal assessment based on literature review. However, for in-house prepared solutions used for quantitative analysis, such as sample or standard solutions used in assay or impurity testing or titration solutions, FDA requires that formal stability studies be conducted to determine an appropriate expiry date. FDA also refers to ICH Q2 which requires sample stability to be evaluated during robustness testing.

FDA Published FY2010 Inspectional Observation Summary

The summary lists 483 citations with detailed and short description, with the frequency of the observation and the related regulatory reference. In all major regulated areas such as biologics, foods, devices and drugs most observations are related to procedures, for example, procedures are not followed, are not adequate or simply are not existing. The report can be viewed on the FDA Website. To learn everything about FDA compliant procedures attend the audio seminar "Writing Effective SOPs For Regulatory Compliance: Content, format, approval, training, distribution and enforcement.",and receive example SOPs.

FDA Proposes Enhancing Search Criteria for Inspections Database

FDA may consider whether to add specific search criteria (e.g., those that would enable product-specific or violation-specific searches) to its inspections database to make it user-friendly and improve data analysis. The idea was included in a list of eight draft proposals for increasing transparency that the agency published on Oct. 3, 2011. FDA also proposed introducing sophisticated search capability, such as predictive name searches. As of October 2011 the article is available on the PharmTech website. It also includes a link to the draft proposals. Copyright rests with the publisher. For other articles from PharmTech, click here

Inadequate Response to 483 Observations Causes Part 11 Warning Letter

 FDA expects a detailed and adequate response to 483 inspectional observations otherwise the observation will be cited in a warning letter.  . This became clear from a recent warning letter. The company did not regularly back-up raw data. Even though the company responded that the deviation will be corrected through a new SOP to include the implementation and installation of qualified backup software on the server this response was not sufficient because the company failed to adequately address whether critical data not backed-up previously could be recovered. The Warning Letter can be downloaded from the Labcompliance Usersclub. Scroll down to W-256. Non members can preview excerpts. To learn more about recent Part 11 related warning letters and how to respond to 483s attend the audio seminar  "Learning from Recent FDA Warning Letters related to Computer Validation and Part 11 Compliance.

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 SOP "Handling Security Patches". To download your free copy, go to the Network Quality and Compliance website. Scroll down and click on the corresponding ICON on the left (offer expires on November 4 , 2011). Labcompliance offers more than 130 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

Audio Seminar Schedule

  1. How to get the most out of Supplier Support  for Equipment and Computer Validation
    Strategies for suppliers to maximize business and for users to minimize validation cost
    November 17, 2011
  2. Cost Effective Computer System Validation: Step-by-Step
    With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation
    December 1, 2011
  3. Validation of Analytical Methods and Procedures
    Design, Conduct and Document for Efficiency and FDA Compliance
    December 13 2011
  4. FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control
    With Strategies and best Practice Guides for easy Implementation
    December 20, 2011
  5. FDA Compliant SFC Qualification and Performance Testing
    Learn how to select, conduct and document the right tests in the right sequence
    January 12, 2012

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Recent Warning Letters and 483's Related to Computer Validation and
Part 11
Labcompliance.com