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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

 

Five 2-day In-person Interactive GMP, Part11 and Validation seminars available in America, Europe and Asia delivered by Dr. Ludwig Huber. 

 

Dec 15, 2014

Version 4 just released

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

With Quality Manual and  SOPs for easy implementation 

 

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

 

Understanding and Implementing the New EU-PIC/S Annex 11
Learn all about similarity and difference to Part 11
December 11, 2014

 

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

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.

 

 

 

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.

The EC published three updated EU GMP Chapters

The European Commission has published the final versions of Chapters 3,
5,and 8 of the EU GMP Guide. Chapter 3 covers premises and
equipment, Chapter 5 covers production, and Chapter 8 covers complaints, quality defects and product recalls. These chapters will be effective March 1, 2015. For a brief overview of the new highlights, click here.

ICH develops Training Material for ICH Q3D

ICH plans to to establish a working group to prepare a comprehensive training program and associated materials to facilitate an aligned interpretation and a harmonized implementation of ICH Q3D in the ICH and non-ICH regions. More details such as the background of the proposal, statement of the perceived problem, issues to be resolved, training contents, the type of working group and timing can be found in a concept paper and business plan.

New Version 4.0 of the ISO 17025 Accreditation Package Released

On December 16 Labcompliance has released a new major revision of the popular ISO 17025 Accreditation package. The new version includes 8 new SOPs, an updated quality manual,  an updated step-by-step implementation plan, a new tool kit for estimating costs and timing for implementation. In addition most other key documents have been updated to reflect most recent recommendations from official accreditation committees and laboratory quality system experts. With the new additions the package includes 51 SOPs for chemical testing and 38 SOPs for mechanical, optical and electronic testing and calibration laboratories.  For additional information and ordering, click here

PDA published Definitions for four key Quality Metrics

PDA published definitions for four key quality metrics in an updated version of its "Points to Consider: Pharmaceutical Quality Metrics," which was first published in December 2013. The paper is available to the public in the Sept/Oct PDA Journal of Pharmaceutical Science and Technology. For more information and to download the paper, click here.

USP proposes Chapter <1210>: Statistical Tools for Procedure Validation

This chapter is proposed as a companion chapter to Validation of Compendial Procedures 1225 with the purpose of providing statistical methods that can be used in the validation of analytical procedures. Specifically, the chapter discusses all of the following analytical performance characteristics from a statistical perspective: accuracy, precision, range, detection limit, quantitation limit, and linearity. Additional related topics that are discussed in this proposed new chapter include statistical power, two one-sided test (TOST) of statistical equivalence, tolerance intervals, prediction intervals, corrected Akaike Information Criterion (AICc), Bayesian analysis, experimental design, calibration, and variance pooling strategy. The proposal has been published in USP's Pharmacopeial Forum 40(4). To access the free PF, click here.

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 "Qualification of PC Clients". To download your free copy, go to the Network Quality Package website. Scroll down and click on the corresponding ICON on the left (offer expires on December 31 , 2014). 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 Available later in November

Thank you for 2014 and best wishes for 2015

Labcompliance wishes you and your family quiet and peaceful hollidays and a Happy New Year 2015! We sincerely thank you for your kind support this year and look forward to work with you in 2015.

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, 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.