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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

 

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

 

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.

 

 

 

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

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 tests (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

New Guidance from OECD on Using Computers for GLP Studies

Almost all guidances on "Validation and Use of Computers" from FDA and related international agencies and industry task forces are targeted to GMP. Now after almost 20 years the OECD has released a new version of the popular Consensus Document: "The Application of GLP Principles To Computerised Systems". Compared to the older version the new one is more detailed and has some very specific requirements. In addition to validation it addresses the regulatory needs of modern IT equipment and when implemented right, also has business benefits through reduced failure rates. The guide includes all details and what to do but it does not have specific information for implementation. Attend the new Labcompliance seminar to learn everything about the new requirements and get best practice for easy implementation.

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.