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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 iRecorded, available at any time


Ensuring Data Integrity for FDA/EU Compliance
Comply with FDA Part 11 and EU/PICS Annex 11 for paper, electronic and hybrid records


Quality by Design (QbD) for Development and Validation of Analytical Methods

Learn how to design robust analytical for easy transfer and to avoid OOS situations



FDA/EU Compliant Handling of OOX Test Results

Learn how to investigate out-of-trend (OOT) and out-of-expectation (OOE) vs. OOS results

Recorded, available at any time


Lessons from Recent Quality Control Lab related FDA Warning Letters

Learn how to use warning letters and 483s to other firms to design compliance into your lab

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.




Labcompliance offers more in-Person Workshops

Labcompliance has extended the offerings for in-Person workshops in several areas: "Computer System Validation and Part 11/Annex 11  Compliance", "GMP Compliance for Quality Control and Contract Laboratories",. "Analytical Method Validation, Verification and Transfer", "Analytical Instrument Qualification and System Validation" and "Validation and Part 11 Compliance in Laboratories". All workshops can be delivered as public and as in-house workshops. Public workshops typically are organized and managed by professional conference providers. In-house seminars are organized either by professional conference providers or by the end-user company. For a complete list of workshops with ordering process and links to pages with individual contents, click here.

New Article on the Development and Analysis of Biosimilars

The article written by  Fiona Greer, the global director of the BioPharma
Services Development at SGS Life Science Services gives an update on the development of biosimilar drugs and the importance of their analytical characterization. The article starts with a comparison of EMA and FDA approvals. The EMA approved several biosimilars since the first approval of Sandoz’s version of the human growth hormone somatropin back in 2006. In the United States no biosimilars are approved in February 2015, but numerous products are in development.. Sandoz was the first to apply for biosimilar approval in the US and FDA approval for Zarxio may come soon. The article also reports on analytical requirements according to a recently revised EMA quality guideline. As of March 2015 the article is available on the PharmTech website. Copyright rests with the publisher. For other articles from PharmTech, click here.

Updates on Using Cloud Computing in Regulated Environments

Cloud computing can significantly reduce investment and operating costs for IT operations. However when used in FDA and other regulated environments they need to be validated to ensure consistent on-going performance and security and integrity of stored and managed data. While there are guidelines available on how to deal with standard networks and computer systems this is not the case for virtual  networks and cloud computing. The topic is discussed in a new Labcompliance Audio seminar.  During the seminar, the speaker will present strategies and an overview and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation 

FDA Collects Information on Record Keeping Requirements for
Finished Drugs

On February 25 the US Food and Drug Administration (FDA) has been announcing that a proposed collection of information has been submitted to the Office of Management and Budget for review. The document can be viewed as a summary of GMP record keeping for finished drugs.  The document also includes a table with estimated annual record keeping burden. The FDA expects fax written comments on the collection of information by March 27, 2015.,

FDA added  more Data Integrity Questions to the cGMP Q&A Webpage

The FDA had initiated this website back  in 2009 when they got many questions related to GMP and Part 11 data integrity requirements. For example  one of the most frequently asked question was about retaining electronic copies of  chromatographic raw data. The answer was very clear such that e.g., for HPLC paper print-outs are no substitutes for electronic records. Especially after FDA did experience many other issues with data integrity, more questions have been answered. Examples are: "Why is FDA concerned with the use of shared login accounts for computer systems?",  "Can electronic signatures be used instead of handwritten signatures for master production and control records?" and "In warning letters to firms, why has FDA objected to the practice of using actual samples to perform system suitability testing (sometimes also referred to as "trial," "test," or "prep" runs)?" Answers are available on FDA's CGMP Q&A website. To learn everything on FDA's recent data integrity expectations attend the Labcompliance seminar: Ensuring Data Integrity for FDA/EU Compliance The seminar will also discuss the most recent related FDA warning letters.

FDA publishes Guidance Agenda for 2015

The FDA has published a list with "New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2015". The guidances are segmented into 14 categories. For example, the both section 'Biopharmaceutics'  and 'Biosimilarity' include 4 guidances, the category 'Pharmaceutical Quality/CMC' includes 13 guidances, examples are 'Elemental Impurities in Drug Products Marketed in the United States' and 'Comparability Protocols for Approved Drugs: Chemistry, Manufacturing, and Controls Information'. The complete list is available on the FDA website.

FDA mandates SOPs for Management of Out-of-Trend (OOT) and other Atypical Results

Two resent FDA warning letters and 483s make it clear that not only OOS results require failure investigations but also OOT and other atypical results. The 483  tated: "There is no standard operating procedure in place that describes the steps to be followed during an Out-of-Trend (OOT) Investigation, besides, the OOT Investigation performed was inadequate." The Warning Letter was related to other atypical results: "Failing or otherwise atypical results were not included in the official laboratory control records, not reported, and not investigated." The 483 and the warning letter can be downloaded from the Labcompliance Usersclub. Scroll down to W-241 and W-290. Non members can preview excerpts. To learn everything about FDA's expectation for handling Out-of-trend and other atypical situations, attend the Labcompliance audio seminar "FDA/EU Compliant Handling of OOX Test Results", and receive 10+ best practice guides for easy implementation, including an SOP on handling OOT situations

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 Laboratory Data Integrity Package website. Scroll down and click on the corresponding ICON on the left (offer expired on March 31, 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

Audio Seminar Schedule

In Person 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: Zurich, Singapore, San Diego, 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.