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2-Day Workshop

FDA/EU GMP Compliance for Quality Control and Contract Laboratories

 Istanbul / TURKEY

June 07 & 08, 2011

 

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

 

Validation and Use of Excel® Spreadsheets in Regulated Environments

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

Recorded

 

How to Develop an FDA Compliant Risk Management Master Plan

The most important document for efficient and consistent risk management

Recorded

 

Auditing Computer Systems for Part 11 and Annex 11 Compliance

Prepare your organization for upcoming FDA and EU inspections

Recorded, available at any time

 

Raw Data in FDA Regulated Environments

FDA/EU compliant recording, maintenance and archiving

Recorded

 

FDA Compliance for Biopharmaceutical Laboratories

Become familiar with FDA regulations and get tool kit for implementation

June 16, 2011

 

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

With SOPs, templates and examples for easy implementation

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

 

How to Prepare Yourself for FDA's New Part 11 Inspection Program

Learn what the FDA is looking for and how to respond

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

 

New  release in
2010 

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

 

 

Labcompliance News, April 2011

FDA Warning Letter Issued for Inadequate Use of Excel Spreadsheets

Spreadsheets such as Excel used in FDA regulated environments should be verified for accuracy and calculations used in the spreadsheet program should be documented. This became clear during a recent inspection of a prescription drug manufacturer which resulted in a warning letter. For example, the letter reads: "You continued to release products based on assay results generated by the spreadsheet that have not been verified for accuracy.". Furthermore the FDA noted that: "Your laboratory records did not include a record of all calculations performed in connection with laboratory tests as required by 21 CFR §211.194(a). For example, the notebook does not document reference to the spreadsheet calculation used to generate the results. Your SOP omits instructions to include in the notebook the reference to the spreadsheet calculation used to generate the results, as well as the raw data and calculations." The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-237.  To learn how to validate Excel Spreadsheets for FDA regulated environments attend the audio seminar  "Validation and Use of Excel® Spreadsheets in Regulated Environments"

PIC/S Publishes Questions & Answers Document Regarding Distribution Activities for APIs

This list of Questions and Answers were agreed by inspectors of the PIC/S Expert Circle of APIs at a meeting in Dublin, Ireland. The document is intended to provide guidance to inspectors when inspecting areas relating to two topics: (a) Supply Chain & Distribution and (b) Repackaging & Relabelling operations. References to the PIC/S Guide to GMP Part II are provided to answers, where appropriate. The document has been written by inspectors for inspectors. But what is good to know for inspectors is also good for the industry, because the same questions will come up during inspections. And don't forget, PIC/S includes 39 healthcare agencies including all EU member countries, FDA, Singapore and Australia.The document can be downloaded from the PIC/S website.

Microsoft Offers SharePoint 2010 Configuration Guidance for Part 11 Compliance

This guidance describes the overall SharePoint architecture needed to support compliance including both conceptual and product-level architectures  It provides a set of use cases for compliance and then detail the configurations necessary to support those use cases. It also provides a mapping between 21 CFR Part 11 and the configurations detailed as part of the use cases that support each individual line of the regulation. .As of April 2011 the Guidance can be downloaded from the Microsoft Website.  Equivalent information is available for SharePoint 2007.

FDA  is Using Excel in its own 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. 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 FDA's and about current  regulatory expectations and enforcement practices for using Excel, and to receive two FDA Spreadsheet Information Bulletins click here.

"Raw Data for Annual Instrument Re-Qualification not Maintained" cited in Warning Letter

Raw data of all regulated records should be maintained and available during inspections.  During an inspection of an contract testing laboratory FDA investigators found that not all raw data were available. The letter reads: "Your firm fails to maintain raw data associated with the requalification and calibration of your laboratory instruments. During the inspection the investigators were informed that the annual re-qualification and calibration of your laboratory equipment (e.g.,HPLC, GC, polarimeter, and analytical balance) is performed However, you were unable to provide raw data or documentation regarding the qualification and calibration of your instruments and data to demonstrate that your quality unit reviewed and approved the work performed by your contractor" The Warning Letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-247. The main issue about raw data is knowing what exactly FDA expects to be retained as raw data. To learn everything about definition, maintenance and archiving of raw data, sign up for the audio seminar  "Raw Data in FDA Regulated Environments: FDA/EU compliant recording, maintenance and archiving".

Is the U.S. Really Slower than Europe in Approving New Drugs?

FDA often hears claims that the U.S. approves new drugs less quickly than other regulatory agencies, particularly the European Medicines Agency (EMA). FDA made an investigation and answered the question based marketing approval of 57 novel drugs approved by both FDA and EU from 2006 to 2010. The outcome was that, in many cases, FDA gets a drug on the market faster than does Europe. The detailed comparison can be downloaded from the FDA website.

Labcompliance Offers Workshop for Validation of Analytical Methods

Labcompliance offers a workshop about Validation of Analytical Methods. The workshop is dedicated to quality control and contract laboratories. It provides an excellent opportunity to analysts, and middle and senior management of pharmaceutical and API manufacturers to learn about requirements for analytical methods validation in laboratories. Practical examples, case studies and interactive exercises are dispersed into and between the presentations. About 50% of the total are dedicated to interactive discussions and practical sessions with real life examples. The workshop is offered for conference/seminar providers and to industry for in-house training. The workshop has been conducted by Dr. Ludwig Huber at Analytica Vietnam. For more information contact Ludwig Huber.

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 "Transfer of Analytical Methods". To download your free copy, go to the Laboratory Compliance Package website. Scroll down and click on the corresponding ICON on the left (offer expires on April 1, 2011). Labcompliance offers more than 120 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

Audio Seminar Schedule

  1. Validation and Use of Excel® Spreadsheets in Regulated Environments
    Comply with FDA Part 11, the PIC/s Good Practice Guide and the EU Annex 11
    Recorded
  2. Developing a Risk Management Master Plan
    A must for efficient and consistent implementation of risk management projects
    Recorded
  3. Raw Data in FDA Regulated Environments
    FDA/EU compliant recording, maintenance and archiving
    Recorded
  4. FDA Compliance for Biopharmaceutical Laboratories
    Become familiar with FDA regulations and get tool kits for implementation
    Recorded

New or Updated Sites

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