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56 Usersclub Additions

- 15 SOPs
- 10 Examples/Checklists
- 3 Forms/Templates
- 7 FDA Presentations
- 21 Warning Letters

 

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

 

Validation and Use of Excel Spreadsheets in Regulated Environments
Comply with GxPs for drugs, APIs and Devices, with FDA Part11, and with EU-PIC/S Annex 11
Recorded, available at any time

 

Validation and Use of Cloud Computing in FDA Regulated Environments

Comply with GXPs, Part 11, EU Annex 11 and other regulations

July 25, 2013

 

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

With Strategies and best Practice Guides for easy Implementation

 August 1, 2013

 

How to Ensure Part 11 Compliant Integrity of Laboratory Data

Comply with new FDA inspection practices and EU Annex 11 requirements

May 23, 20133

 

Regulatory Aspects of 'Biosimilar' Drugs

Understand and Implement recent FDA and updated EMA Guidances

June 27, 2013

 

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

With SOPs, templates and examples for easy implementation

Recorded, available at any time

 

Elemental Impurities According to the Final USP Chapters 232/233

With updates on the new ICH Q3D Guide: Elements, Limits and Schedule

Recorded, available at any time

 

Quality by Design (QbD) for Analytical Method Development and Validation
Learn how to design robustness for easy transfer and to avoid OOS situations
Recorded, available at any time

 

Validation and Use of Cloud Computing in FDA Regulated Environments

Comply with GXPs, Part 11, EU Annex 11 and other regulations

Recorded, Available at any time

 

Understanding and Implementing the New EU-PIC/S Annex 11

Prepare Yourself for the upcoming Inspections and Enforcement

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

 

Qualification and Use of Virtual Networks in Regulated Environments

With Strategies and Tool Kit for Compliance and System Uptime

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

 

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

 

 

 

 

Labcompliance News May 2013

USP Offers Free Compendium with Testing Standards for Herbal Ingredients used in Traditional Medicines

The new Herbal Medicines Compendium (HMC) will  help ensure the quality of  ingredients used in traditional herbal medicines. With the first set USP proposes 23 ingredients for comment by all interested stakeholders worldwide. Standards such as those in the Herbal Medicines Compendium may be used by regulators and other stakeholders in many countries as a tool against adulterated or poor-quality herbal medicines. As of May 2013 the full article is available in the USP website.

“An Outlook on U.S. Biosimilar Competition,”
“An Outlook on U.S. Biosimilar Competition,”

An "Outlook on U.S. Biosimilar Competition", Life Sciences Report available

The report has been released by the IP & Science business of Thomson Reuters, a worldwide provider of intelligent information for businesses and professionals The report provides a view of the challenges facing companies entering the U.S. biosimilar drug market and key players predicted to break into this developing pharmaceutical space.  According to the report U.S. lags behind some other nations entering the entering the global biosimilar market, The report also review  emerging regulatory developments in India and China and identifies potential leaders of the U.S. market, including Amgen, Hospira, and Sandoz.  As of May 2013 more details are available on the Packworld Website. To learn more  about regulatory developments of biosimilars in US and Europe, attend the Labcompliance audio seminar: Regulatory Aspects of 'Biosimilar' Drugs.

'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. 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.

Generic Drug Manufacturer agrees to pay M$500 Fine for GMP Violations

After a year when it entered into a consent decree for serious cGMP violations, the drug manufacturer has now agreed to pay $500 million to issues with the FDA. In 2008, the FDA banned the company from selling about 30 drugs in the United States after it found manufacturing deficiencies at facilities in India. In 2009, the FDA had accused the company of falsifying data and test results in drug applications and halted reviews of drugs made at a plant in northern India. GMP violations included faking stability data and bio equivalence data to support several drugs that were to be delivered to foreign countries. As of May 2013 the full article is available at the ibn-live website. Copyright rests with the publisher To learn everything how to ensure and document FDA compliant integrity of laboratory records attend the Labcompliance Audio Seminar "How to ensure Part 11 compliant integrity of laboratory data"

Excipient and Pharmaceutical Manufacturers Concerned about USP 232/233 Timeline

According to an article  of 'in-pharma' manufacturers of pharmaceutical products and excipients raised concerns about the current requirements and timeline for elemental impurities following the new USP chapters <232/233>. According to USP publications the chapters should be implemented on May 2014 and the current chapter <231> for heavy metal analysis will be obsolete at the same time. This means the equipment must be ordered, installed and qualified, the methods must be verified if companies choose one of the two compendial methods or validated for alternative methods. In addition SOPs should be in place for routine use and personnel must be trained. The article also reported that the FDA began setting up a laboratory which took half a year. As of May 2013 the full article is available in the 'in-pharmatechnologist website. Copyright rests with the publisher. To learn everything about elemental impurities according to USP 232/233 attend the Labcompliance Audio Seminar 311.

Laboratory Data Integrity Issues Cited as FDA GMP Deviations

Data integrity and security issues are not only 21 CFR Part 11 issues but severe GMP violations. Corresponding citations have been cited in FDA warning letters and 483s even long before Part 11 has been issued. Examples from a 483 inspectional observation are: "Operations that could affect the integrity of chromatographic data files collected and processed by the data acquisition system are  not controlled by electronic audit trails that maintain who, why and what was changed to any given sample record", "The firm does not electronically store all integration parameters and chromatograms", "There are insufficient security measures in effect to ensure the integrity of chromatographic data housed in the Quality Control Laboratory", and "The firm lacks the controls necessary to ensure the integrity of raw data generated by the laboratory computer system". It is interesting that similar type of Part 11/GMP violations have been recently cited as part of FDA's Part 11 inspection initiative from 2010 to 2013. To get full access to the 483 and to learn everything how to ensure and document FDA compliant integrity of laboratory records attend the Labcompliance Audio Seminar "How to ensure Part 11 compliant integrity of laboratory data.

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 June 10, 2013). 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

2-day Interactive In-Person Seminars with Dr. Ludwig Huber

Audio Seminar Schedule

  1. Validation and Use of Cloud Computing in FDA Regulated Environments
    Comply with GXPs, Part 11, EU Annex 11 and other regulations
    July 25, 2013
  2. FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control
    With Strategies and best Practice Guides for easy Implementation
    August 1, 2013
  3. Regulatory Aspects of 'Biosimilar' Drugs
    Understand and Implement recent FDA and updated EMA Guidances
    June 27, 2013

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Publishers Note

PUBLISHER'S NOTE: Some of the documents presented in this News section may require registration to the Labcompliance Usersclub to access their information. At the time of the News release, all links to other websites functioned, but Labcompliance cannot guarantee the accuracy of the information and that the links will not disabled.