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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

 

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

 

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

 

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

 

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

 

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

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.

 

 

 

PIC/S adopts the New EU GMP Annex 15: Validation and Qualification

Shortly after the final release of the EU GMP Annex 15 the Pharmaceutical Inspection convention Cooperation Scheme (PIC/S) has adopted the document as PIC/S Annex 15.  The Annex has been significantly updated compared to the version of 2001 but also compared to a draft version from 2014. The Annex is in line with other modern related documents such as ICH Q8/9/10/11 and has components from Quality by Design,  Risk Assessment and Quality Systems, for example, continuous lifecycle management, and continuous  verification and improvements. With the adoption by PIC/S the Annex will be expanded from EU countries to worldwide acceptance. Currently PIC/S consists of 46 participating regulatory authorities worldwide, including the 28 EU member states, but also  the US FDA, Health Canada and many international agencies from Latin America, Africa, Asia and Australia. Both the EU and PIC/S guidelines take effect October 1, so now it is a good time to learn about the Annex.. Attend the new Labcompliance Seminar to learn everything about the requirements and how to implement the new Annex.

EU Issues Final Guidance for Excipient GMPs   

On March 19 the European Commission has published long-awaited guideline for GMP’s for excipients in the official journal of the European Union. The "Formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use" has being published after almost two years of the publication of the draft guidelines. The final guideline is  more detailed and contains more stringent requirements than the draft guideline. The excipient risk assessment/risk management procedure should be incorporated in the pharmaceutical quality system of the manufacturing authorization holder. The guidance can be downloaded from the EU website.

New Date for USP Chapters 232 and 2232

USP announced January 1, 2018 as the new effective date for General Chapters <232> Elemental Impurities - Limits and <2232> Elemental Contaminants in Dietary Supplements. The revised versions of General Chapters <232> and <233> Elemental Impurities—Procedures will appear in Second Supplement to USP 38-NF 33 and become official on December 1, 2015. This version of General Chapter <232> contains limits that align with the ICH Q3D Step 4 document and will be implemented as described above. To read the whole text please click on the following link to the USP homepage.

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.

New Primer on FDA Inspections and Warning Letters

This new 31-page primer entitled "Compliance by Design for Pharmaceutical Quality Control Laboratories" focuses on frequently cited GMP deviations observed during FDA inspections. Several hundred GMP-related Warning Letters and inspection reports were analyzed. Readers can use this information to educate themselves on the current thinking of FDA inspectors as well as on mistakes made by other companies and how to avoid them. Based on information from these citations, certain best practices have also been included that can help design regulatory compliance into quality control laboratories . The primer has been written by Dr. Ludwig Huber and published by Agilent Technologies. The primer is available from the Agilent website as PDF file.  

Audio Seminar Schedule

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 and Chicago.

For dates and detailed contents, click here.

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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.