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56 Usersclub Additions
Last update: Feb20-2014

- 15 SOPs
- 10 Examples/Checklists
- 3 Forms/Templates
- 7 FDA Presentations
- 21 Warning Letters

 

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

 

Now with Qualification of Virtual Networks

With three audio seminars

With 28 SOPs. 

 

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

 

Computer System Validation: Step-by-Step

With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation

September 4 2014

 

Review of Analytical Methods as Alternative to regular Revalidation

Understand how to remain in compliance at much lower costs and at higher effectiveness

October 4, 2014

 

Managing Out of Trend Results in Pharmaceutical Quality Control

With Strategies and best Practice Guides for easy Implementation

October 28, 2014 

 

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

 

Comparing GLP with GMP

Learn about similarities and differences and when to apply one or the other

June 5, 2014

 

Validation and Control of Excel Spreadsheets for FDA Compliance

Understand requirements and get tool kits for easy implementation

June 10, 2014

 

Auditing QC Laboratories for FDA Compliance

Learn how to use internal audits in preparation for regulatory inspections

June 18, 2014

 

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.

 

 

 

New Article on the Importance of Quality Systems

Siegfried Schmitt, principal consultant at PAREXEL, discusses the importance of quality-technical agreements. The author specifically points out the need for such agreements not only between different companies but also within a company. He also references organizations mandating related agreements such as the European Medicines Agency (EMA), FDA, the World Health Organization (WHO), Pharmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme (PIC/S), and the International Conference on Harmonization (ICH). As of August 2014 the article is available on the PharmTech website. Copyright rests with the publisher. For other articles from PharmTech. As of October 2011 the article is available on the PharmTech website. It also includes a link to the draft proposals. Copyright rests with the publisher. For other articles from PharmTech, click here

FDA requires Validation of Data Integrity during Software Validation  

Software functions to ensure the security and integrity of regulated records are considered to be high risk and need to be validated for correct functioning. This became obvious during a recent inspection when the inspector looked at a computerized analytical system that was used to analyze samples in preparation for NDAs and data integrity was not validated. "The letter reads: The firm did not validate the integrity acquisition system ensure that analysts cannot rewrite or delete analytical data during analysis". The warning letter can be downloaded from the Labcompliance Usersclub. Scroll down to W-282. Non members can preview excerpts. Attend the new Labcompliance audio seminar: Computer System Validation - Step-by-Step to learn everything about risk based validation and how to test the integrity of electronic records.

PIC/S adopts the EU Good Distribution Practice Guide

The PIC/S Committee has adopted a Guide on Good Distribution Practice (GDP), which has entered into force on 1st June 2014. The PIC/S GDP Guide is based on the EU GDP Guide. While the EU GDP Guide is legally binding in the EU/EEA, the PIC/S GDP Guide is a non-binding guidance document in PIC/S, as not all PIC/S Participating Authorities are competent for GDP inspections. The GDP Guide will be posted on the PIC/S website shortly before its entry into force. See http://www.picscheme.org/publication.php

FDA expects an SOP to manage Out-of-Trend (OOT) Situations

FDA Guide on Investigating Out of Specifications Test Results for Pharmaceutical Production also mentions out-of-trend situations. "Although the subject of the guidance is OOS results, much of the guidance may be useful for examining results that are out of trend (OOT)". No further details are given. What it can mean in practice became obvious during an inspection of a drug manufacturer that resulted had in several 483 observations. One of them stated: 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 483 can be downloaded from the Labcompliance Usersclub. Scroll down to W-241. Non members can preview excerpts. To learn everything about FDA's expectation for handling Out-of-trend situations, attend the Labcompliance audio seminar and receive 10+ best practice guides for easy implementation, including an SOP on handling OOT situations.

New FDA Guidance on Statistical Evaluation of Stability Data for Veterinary Products

The U.S. FDA has adopted the VICH guidance on statistical evaluation of stability data for veterinary products. The guidance has been developed for veterinary use by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide recommendations on how to use stability data generated in accordance with the principles detailed in the VICH guidance entitled “Stability Testing of New Veterinary Drug Substances and Medicinal Products, GL3(R)” to propose a retest period or shelf life in a registration application. The Guidance is available for download from the FDA 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 SOP "Quality Assessment of Software and Computer System Suppliers". To download your free copy, go to the Part 11 Compliance website. Scroll down and click on the corresponding ICON on the left (offer expires on August 15 , 2014). Labcompliance offers more than 150 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

  1. Computer System Validation: Step-by-Step
    With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation
    September 4, 2014
  2. Review of Analytical Methods as Alternative to regular Revalidation
    Understand how to remain in compliance at much lower costs and at higher effectiveness
    October 4, 2014
  3. Managing Out of Trend Results in Pharmaceutical Quality Control
    With Case Studies on how to Avoid and Respond to Recent 483s/Warning Letters
    October 28, 2014

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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.