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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

 

200 Seminars !!!
Receive 50% Jubilee Discount

Cost Effective Validation of Laboratory Computer Systems

With industry proven examples for all validation steps

October 25, 2012

 

Calibration and Qualification of Stability Chambers

With 10 examples/templates for all validation steps

October 11, 2012

 

FDA Compliant Use of (Certified) Reference Material

Strategies for selection, purchasing, testing and documentation

Recorded, available at any time

 

Laboratory Equipment Qualification according to USP <1058>
With SOPs, Templates and Examples for Easy Implementation
Recorded, available at any time

 

Verification of Compendial Methods according to the Revised USP Chapter <1226>

Understand the new risk based approach and get real world case studies for testing

Recorded
available at any time

 

Selecting Acceptance Criteria for Regulatory Method Validation

Learn through case studies and get inspection ready documentation

Recorded, available at any time

 

Qualification and Use of Virtual Networks in Regulated Environments

With Strategies and Tool Kit for Compliance and System Uptime

Recorded, available at any time

 

Validation and Use of Excel® Spreadsheets in Regulated Environments

Comply with Part 11, QSR, and Annex 11.

Recorded
Available at any time

 

Implementing the New USP Chapters 232/233 for Elemental Impurities

Learn how to comply with FDA, USP and ICH Requirements

Recorded, available at any time

 

Verification of Compendial Methods according to the Revised 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, available at any time

 

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, available at any time

 

Analytical Instrument Qualification According to USP <1058>

With SOPs, Templates and Examples for Easy Implementation

Recorded, available at any time

 

 

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

 

 

 

 

Labcompliance News September 2012

APIs imported to Europe must comply with EU GMP Standards

As of 2 January 2013, all imported active substances must have been manufactured in compliance with standards of good manufacturing practices (GMP) at least equivalent to the GMP of the EU. The manufacturing standards in the EU for active substances are those of the ‘International Conference for Harmonisation’ – ICH Q7. As of 2 July 2013, this compliance must be confirmed in writing by the competent authority of the exporting country. This document must also confirm that the plant where the active substance was manufactured is subject to control and enforcement of good manufacturing practices at least equivalent to that in the EU. For more information click here. To get a good overview on GMP regulations, attend the Labcompliance Audio Seminar and get 10+ Best Practice Guides for easy implementation.

New  FDA Guidance on Pyrogen and Endotoxins Testing

This 10-page guidance written in a  question&answer format provides recommendations for biological product, drug, and device firms on FDA’s current thinking concerning the testing recommendations and acceptance criteria in the United States Pharmacopeia (USP) Chapter <85> Bacterial Endotoxins Test. USP Chapter<161> Transfusion and Infusion Assemblies and Similar Medical Devices, and the Association for the Advancement of Medical Instrumentation (AAMI) ST72:2002/R2010, Bacterial Endotoxins - Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing (AAMI ST72). To view and download the guideline, click here.

FDA Recommends 3rd Party Consultant for Lab Equipment Qualification

The recommendation has been made in a recent warning letter after an inspection of a drug company. The letter reads: "There are several instances of incomplete qualification of equipment and incomplete laboratory data. We recommend that you seek the advice of a third-party consultant for assistance with a complete evaluation to determine the improvements that you will need to make at your firm in order to meet the CGMP requirements." The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-276. No further details have been given in the FDA letter on how to qualify lab equipment. However, 3rd party consultants are not always necessary, because there is other help. The global standard for laboratory equipment qualification is the USP chapter <1058>. To learn everything about USP <1058> and to receive recommendations and practical examples for trouble free implementation attend the Labcompliance Seminar: "Laboratory Equipment Qualification according to USP <1058>"

FDA`s Presentation on Quality by Design for Analytical Methods

The topic has been presented by Yubing Tang, PhD, from the FDA/CDER.  After an overview of QbD Dr Tang talked about the role of analytical methods under QbD approach and the benefits of QbD for the industry. Most interesting was the part on 'Regulatory considerations of the QbD approach for analytical methods'. In the concluding remarks Dr. Tang encouraged applicants to discuss ‘novel’ QbD implementation approaches with the agency prior to submission . The presentation  with 21 slides is available for members of the Labcompliance Usersclub and for attendees of the Labcompliance audio seminar "Quality by Design (QbD) for Development and Validation of Analytical Methods". 

Video on FDA Drug Development and Approval

We at Labcompliance get many questions on how industry develops new drugs and how FDA decides if a drug is safe and effective. There is 13 min video that gives a quick overview on the process. While the efforts to bring a drug to the market regarding time and cost are far below today's and some other numbers are  below today's reality, the process is well described.. The video is part of the program 'FDA Approved'.

EURACHEM Releases the 3rd Edition of the Measurement Uncertainty Guide

The guide has been produced by a joint EURACHEM/CITAC Measurement Uncertainty Working Group with support from the was supported by the UK National Measurement System. This third edition retains the features of the second edition and adds information based on developments in uncertainty estimation and use since 2000. The additional material provides improved guidance on the expression of uncertainty near zero, new guidance on the use of Monte Carlo methods for uncertainty evaluation, improved guidance on the use of proficiency testing data, and improved guidance on the assessment of compliance of results with measurement uncertainty. For more information on the content and how to download at no cost, visit the EURACHEM Website.

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 "Electronic Audit Trail: Specifications, Implementation and Validation". To download your free copy, go to the Part 11 Compliance Package website. Scroll down and click on the corresponding ICON on the left (offer expires on September 30, 2012). Labcompliance offers more than 150 SOPs that help to comply with FDA and ISO 17025 requirements. For titles and ordering, click here.

Conference in Europe

IVT
Qualifying and Validating Cloud and Virtualized IT Infrastructures
Best Practices to Align Innovative Technology with Regulatory Guidance
November 13-14, 2012
Ireland, Dublin, Hilton Hotel

New Audio Seminar Schedule

  1. Laboratory Equipment Qualification according to USP <1058>>
    With SOPs, Templates and Examples for Easy Implementation
    Recorded, available on demand
  2. Calibration and Qualification of Stability Chambers
    With 10 examples/templates for all validation steps
    Recorded, available on demand
  3. Cost Effective Validation of Laboratory Computer Systems
    With industry proven examples for all validation steps
    Recorded, available on demand
    On-line Audio Seminar 300
    Celebrate with us the 200th Audio Seminar and receive 50% Discount
  4. Using Electronic Signatures in FDA and EMA Regulated Environments
    Requirements and Tools for compliance and efficient Implementation
    Recorded, available on demand
  5. Validation of Analytical Methods for GLP and Clinical Studies
    Learn how to design, prepare, conduct and document for FDA compliance
    Recorded, available on demand
  6. Validation and Use of Cloud Computing in FDA Regulated Environments
    Comply with GXPs, Part 11, EU Annex 11 and other regulations,
    December 13, 2012
  7. Understanding and Implementing the New EU Annex 11
    Prepare Yourself for the upcoming Inspections and Enforcement
    December 20, 2012

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