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Jan 2015

Version 4 just released

With strategies and tools for fast, cost-effective Laboratory Accreditation

With Quality Manual and  SOPs for easy implementation


71 New Usersclub Additions
last update
December 1, 2014

- 20 SOPs
- 23 Examples/Checklists
- 7 Forms/Templates
- 4 Master Plans
- 4 Reference papers
- 13 Warning Letters


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


New OECD Guide: Using Computer Systems in GLP Studies

Understanding and Implementing the new OECD Guide for Computer Systems Recorded, available at any time


FDA Compliant HPLC Qualification and Performance Testing

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

Recorded, available at any time


Managing Out of Trend Results in Pharmaceutical Quality Control

With Strategies and best Practice Guides for easy Implementation

Recorded, available at any time


Learning from Recent Warning Letters Related to Computer Validation and Part 11

With Clear Recommendations for Corrective and Preventive Actions

Recorded, available with all reference material at any time


FDA/EU Compliant IT Infrastructure and Network Qualification

With Strategies and Tool Kit for Compliance and System Uptime

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


Laboratory Equipment Calibration and Qualification according to USP <1058>

With SOPs, Templates and Examples for easy Implementation

Recorded, available at any time


Understanding the New EU-GMP Annex 15 on Validation and Qualification

New requirements and strategies for implementation

Recorded, available at any time


Understanding Quality by Design for the Pharmaceutical Industry

Introduction to Principles, Regulatory Activities and Industry Practices

Recorded, available at any time


Validation of Analytical Methods according to the New FDA Guidance

Understanding FDA's New Lifecycle Approach Towards Method Validation

Recorded, available at any time


Impact of Quality by Design on the Analytical Laboratory

Learn through examples on development and validation of analytical procedures

Recorded, available at any time


Understanding FDA's New Guide on Use of Electronic Source Data in Clinical Investigations
With tool kit for cost effective implementation

Recorded, available on demand


Transfer of Analytical Methods According to the New USP Chapter 1224
With SOPs, templates and examples for easy implementation

Recorded, available on demand 


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

With Strategies and best Practice Guides for easy Implementation

 Recorded, available on demand


System Suitability Testing for FDA and USP Compliance

Setting parameters and limits for chromatographic and other methods

Recorded, available on demand


Analytical Equipment Qualification and System Validation for FDA Compliance

Combining the USP <1058> with the new GAMP(TM) Laboratory Computer Systems Guide

Recorded, available on demand


Managing Electronic Raw Data in Regulated Environments

Definition, generation, evaluation and archiving for FDA, ICH, PIC/S and EU compliance

Recorded, available on demand


FDA Compliant Use of (Certified) Reference Material

Strategies for selection, purchasing, testing and documentation

Recorded, available on demand


Regulatory Aspects of 'Biosimilar' Drugs

Understand and Implement recent FDA and updated EMA Guidances

Recorded, available at any time


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

With SOPs, templates and examples for easy implementation

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


Qualification and Use of Virtual Networks in Regulated Environments

With Strategies and Tool Kit for Compliance and System Uptime

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



Learning from Recent Warning Letters Related to GMP Laboratory Controls

For Preparation of FDA and International GMP Laboratory Inspections

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.




New Date for USP Chapters 232 and 2232

USP announced January 1, 2018 as the new date for General Chapters <232> Elemental Impurities - Limits and <2232> Elemental Contaminants in Dietary Supplements. To read the whole text please click on the following link to the USP homepage.

PIC/S establishes formal Program to Harmonize Global GMP Training

One of the key roles and functions that PIC/S provides is training.  In line with this the organization officially established the PIC/S Inspectors' Academy (PIA) . This is an initiative to set up a web-based educational centre under the PIC/S umbrella which aims at harmonizing and standardizing GMP training at an international level. PIA will not only deliver general or advanced training but also serve as a platform for discussion and sharing among regulators thus contributing to global harmonization and interpretation of GMP. The program  will be implemented in various stages and become operational in the third quarter of 2015. For more information read the PIC/S press release

New FDA Guidance on Delaying or Refusing a Drug Inspection

This new final guidance defines the circumstances that FDA would consider to constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection for the purposes of making a drug adulterated. The guidance is strongly recommended to read in preparation for upcoming FDA inspections  For example, readers may be surprised to learn that "Impeding or resisting photography by an FDA investigator may be considered a limitation if such photographs are determined by the investigator to be necessary to effectively conduct that particular inspection". . The guide is available on FDA's website for download.

Data Integrity in Analytical Laboratories has a long History

Nowadays many publications and conference presentations discuss the importance of data integrity in analytical laboratories. Some authors saw this coming as a hot issue already shortly after the launch of 21 CDR Part 11 in 1997. For example, Wolfgang Winter and Ludwig Huber of Agilent Technologies authored an article "Ensuring Data Integrity in Electronic Records" as Part 3 of the article series: "Implementing Part 11 in Analytical Laboratories"  The series has been published in BioPharm in 1999/2000.

Winter and Huber stated several times the importance of data integrity, for example: A significant rule in GMP reemphasized in 21 CFR Part 11 is that ensuring data integrity by protecting original data from accidental and intentional modification, falsification, or even deletion is the key for reliable and trustworthy records." and "The greatest data system challenge in today's laboratories is not controlling and security access, but ensuring data integrity."

Since then Ludwig Huber, now a director at Labcompliance, gave practical recommendations on how to ensure, document and defend integrity of paper and electronic records in many conference presentations, workshops and interactive seminars. Some of the them have been attended or co-presented by FDA officials.  Now Dr, Huber has put all his expertise in the development of what he calls the Laboratory Data Integrity Package and in the 2-day interactive seminar "Validation and Part 11/Annex11 Compliance of Computerized Analytical Systems and Data", with focus on data integrity. The Laboratory Data Integrity Package is offered through Labcompliance and the seminar as public seminar and as In-house Seminar.

Dr. Ludwig Huber in Panel Discussions with FDA Officials

George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about computer system validation and e-records integrity.
Ludwig Huber (right) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference.
Mr. Murray explained FDA's next steps for Part 11

Croatia and Brazil applied for PIC/S membership

 The Croatian Agency for Medicinal Products and Medical Devices (HALMED) applied for PIC/S membership. The Rapporteurs have been appointed at the PIC/S Committee meeting on 20-21 October 2014 in Paris (France). In addition Brazil/ANIVISA has completed its membership application.

The European Medicines Agency pro-actively publishes Clinical Data

On 1 January 2015 a new EMA policy on publication of clinical data entered into force. Under this policy, the Agency proactively publishes the clinical reports submitted as part of marketing-authorization applications for human medicines. The Agency embarked on this process because it believes that the release of data is about establishing trust and confidence in the system, because it will allow the public to better understand the Agency’s decision-making. In addition, academics and researchers will be able to re-assess data sets. The publication of clinical reports will also help to avoid duplication of clinical trials, foster innovation and encourage development of new medicines. For more information, click here.

71 New Documents added to the Labcompliance Usersclub

We have added 50 new documents to the Labcompliance Usersclub. They include 18 new SOPs, 12 examples for practical validation and compliance including checklists . 5 forms/templates, 1 primer, 1 Part 11 implementation plan, 3 important FDA presentations and 10 recent FDA warning letters/483's related to GMP/GLP or GCP. To see the new titles, click here.. User club members can instantly download the new additions. To see the complete list and ordering the users club, click here, and scroll down to 'new additions'. With these additions, the Usersclub has more than 500 documents ready for download.

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 "Archiving and Retrieval of GMP Data and other Documents". To download your free copy, go to the Laboratory Data Integrity package website. Scroll down and click on the corresponding ICON on the left (offer expires on march 10, 2015). Labcompliance offers more than 170 SOPs and examples that help to comply with FDA and ISO 17025 compliance. For titles and ordering of the examples click here

Seminar Schedule

Five 2-day

In-person Interactive GMP, Part11 and Validation seminars

 available in America, Europe and Asia delivered by Dr. Ludwig Huber.
Locations: Singapore, San Diego, Zurich, Boston, Philadelphia and Chicago.

For dates and detailed contents, click here.

New or Updated Sites

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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.