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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. 

 

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

 

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.

 

 

 

EU/PICS GMP Annex 11: The new global Standard for Computer Management and Validation

Since the EU GMP Annex 11 has been adopted by PIC/S the Annex is on its best way to become the golden regulatory standard worldwide, not only for validation  but for the entire management of computer systems. With 44 members including US FDA, all EU member countries, Asian countries such as Singapore, Indonesia, Korea and Japan.PIC/S is the largest regulatory organization. And Annex 11 addresses all computer and data management requirements, Some of them are also directly required by Part 11 and the related guidance document, but also indirectly through FDA inspection and enforcement practices. An example is "Review of electronic Audi Trail". In a new Labcompliance seminar we go through all requirements and give practical recommendations on how to implement them in the most cost effective way..

USP proposes updating the Weighing Chapter <1251>


The changes are being introduced in this chapter in order to align with the modifications recently introduced in chapter Balances <41>. The reference to ASTM E898 is being updated. Additionally, minor editorial changes have been made to update the chapter to current USP style. The proposal has been published in USP's Pharmacopeial Forum 40(6). The deadline for comments is January 31, 2015. To access the free PF, click here.

10 New SOPs Available since November 20

With the addition of 14 new SOPs our offering now includes 172 SOPs. They are available in Word and PDF format and can be used as they are or as a starting point for further customization. For a complete list and ordering click here.

  • Going from GLP to GMP (S-120-01)
  • Going from GMP to GLP (120-02)
  • Elemental Impurity Control According to ICH Q3D (S-416)
  • Assessment Process for Potential Genotoxic Impurities (420)
  • Handling Deviations from Threshold of Toxicological Concern (TTC) (421)
  • Setting up a Quality System for Pharmaceutical Testing Laboratories (503)
  • Review of Analytical Methods and Procedures (605-02)
  • Development and Validation of Analytical Methods through Quality by Design )S-609)
  • Calibration and Qualification of SFCs (S-650)
  • Performance Testing of SFCs (S-651)

CHMP publishes a Guideline on similar biological Medicinal Products

This Guideline outlines the general principles to be applied for similar biological medicinal products also known as biosimilars as referred to in Directive 2001/83/EC as amended, where it is stated that ‘the general principles to be applied [for similar biological medicinal products] are addressed in a guideline taking into account the characteristics of the concerned biological medicinal product published by the Agency’ . This Guideline describes and addresses the application of the biosimilar approach, the choice of the reference product and the principles for establishing biosimilarity. The guide will come into effect April 30, 2015. Applicants may apply some or all provisions of this guideline in advance of this date

Missing HPLC Detector Noise/drift Tests Cited in FDA Warning Letter

FDA warning letters get more and more specific. While neither FDA regulations nor guidance documents specify what HPLC parameters should be tested FDA inspectors start to cite missing or incomplete testing as deviations in warning letters.  Inspectors quote 21 CFR § 211.160(b)(4) with a requirement to conduct adequate calibration of instruments. Example citations are: "Your firm failed to conduct injector and detector performance testing for the xxx system", "For example, no HPLC injector and detector testing for linearity, accuracy, and precision were conducted, such as evaluation of detector for noise/drift; and carryover testing"  This warning is a clear proof of FDA's much tougher policy. It also is a clear statement that HPLC's require full performance testing (OQ) and that system suitability is not enough.  The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 221).  To learn everything about FDA expectations for HPLC initial and on-going testing, attend the Labcompliance audio seminar

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 Package website. Scroll down and click on the corresponding ICON on the left (offer expires on December 15 , 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

Audio Seminar Schedule

  1. Understanding and Implementing the New EU-PIC/S Annex 11
    Learn all about similarity and difference to Part 11
    December 11, 2014
  2. New OECD Guide: Using Computer Systems in GLP Studies
    Understanding and Implementing the new OECD Guide for Computer Systems 
    recorded, available at any time with all reference material
  3. 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 with all reference material

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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.