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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

 

Understanding the Final FDA Guidance for Validation of Analytical Methods

With 10+ best practice guides for easy implementation

Recorded, available at any time

 

Analytical Instrument Qualification According the new Revision of
USP <1058>
 

With SOPs, Templates and Examples for easy Implementation
Recorded, available at any time

 

FDA's New Enforcement of Part 11

Learn what the FDA is looking for and how to respond

Recorded, 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
Recorded, available at any time

 

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

Recorded

 

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

 

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

 

Understanding Quality by Design for the Pharmaceutical Industry

Introduction to Principles, Regulatory Activities and Industry Practices

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

 

Managing Electronic Raw Data in Regulated Environments

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

Recorded, available on demand

 

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

 

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.

 

 

 

USP Publishes New Revision of Chapter <1058>

The first version of USP <1058> entitled Analytical Instrument Qualification (AIQ) has been released in 2008. Since then it has evolved as the golden global standard for analytical instrument qualification, despite of some deficiencies of the first version. For example the industry had difficulties to apply the sections on three equipment categories and for systems comprising equipment hardware and computer systems. And there have always been comments about not enough details for the four qualification phases. In principle these deficiency have been clarified in the new revision with much more details on integrated systems but still some interpretation is required for compliant and efficient implementation. Attend the new Labcompliance seminar to learn everything about the new requirements and get best practice for easy implementation.

FDA releases New Guidance on "Analytical Method Validation"

This guidance with the title: Analytical procedures and methods validation for drugs and biologics" replaces the current draft guidances from 2000 and 2010. It also replaces the 1987 guidance on Submitting Samples and Analytical Data for Methods Validation. The recommendations apply to drug substances and drug products covered in new drug applications, abbreviated new drug applications and biologics license applications.  Opposite to the 2000 guidance the new one includes sections on "Statistical analysis and models" and on "Lifecycle Management". The guidance refers to components used in the quality-by-design approach for analytical methods but does not state anywhere that validation must follow the QbD approach. For example, chemists are advised to follow the lifecycle management process, to begin with an initial risk assessment and follow with multivariate experiments (design of experiments). It will be interesting to see how the industry will react to the requirement that  development data within the method validation section should be submitted to the FDA if they support the validation of the method. The guidance is available for viewing and download from the FDA website. To learn everything about new FDA requirements for validation of analytical procedures and methods, attend the new Labcompliance seminar "Implementing the Final FDA Guidance for Validation of Analytical Methods"

The FDA has released its Draft Guidance on Quality Metrics 

Quality metrics are used throughout the pharmaceutical industry to monitor quality control systems and processes and drive continuous improvement efforts in drug manufacturing. These metrics can also be used by FDA: to help develop compliance and inspection policies and practices. This guidance includes an explanation of how CDER and CBER intend to collect data and use quality metrics to help ensure that their policies and practices continue to support continuous improvement and innovation in the pharmaceutical manufacturing industry. The guidance is available for free download from the FDA website

FDA Answers Questions related to Residual Solvents in Drugs

The questions are answered in form of an official guidance. Even though the title of the guidance addresses "Residual Solvents in Animal Drug Products"  many of the questions also come up for residual solvents in human drugs similarly, as the USP General Chapter <467> Residual Solvents applies to both human and veterinary drugs..Examples for questions are: "What Information should be submitted to demonstrate Compliance With USP <467> ?" and "If a Formulation of a Drug Product Contains a Solvent , is that Solvent Held to the Limits In USP <467>?" The guidance can be downloaded from the FDA website.

Videoclips on Part 11 Basics

The clips are presented by Ludwig Huber. There are a total of 11 clips on most important requirements of Part 11. They include validation, limited authorized access, audit trail, signatures, exact and complete copies, archiving  and raw data  in chromatography. To view the clips go to www.youtube.com and enter as keyword search: ludwig huber, part 11. The videos have been recorded in in 2002. Some of the recommendations are not in line with FDA's current interpretations. For ongoing updates on Part 11 go to the new Part 11 Solutions 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 Best Practice Document "SOP: Change Control of Analytical Equipment". To download your free copy, go to the Laboratory Equipment Calibration and Qualification seminar website. Scroll down and click on the corresponding ICON on the left (offer expires on August 15 , 2015). Labcompliance offers more than 150 SOPs and other documents that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

New Audio Seminars

In Person Seminar Schedule

Ten 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, Chicago and San Francisco.

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.