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62 New Usersclub Additions

- 19 SOPs
- 21 Examples/Checklists
- 8 Forms/Templates
- 2 Master Plans
- 12 Warning Letters 

last update
April 10,  2017


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


Quality by Design (QbD) for Development and Validation of Analytical Methods

With focus on the analytical lifecycle
Recorded, available at any time


FDA Compliant IT Infrastructure and Network Qualification 

With Strategies and Tool Kit for Compliance and System Uptime

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


Understanding the new Revision of USP <1058> 
With examples and procedures for effective implementation

Recorded, available at any time


Understanding the New FDA Guidance for Validation of Analytical Methods

With 10+ best practice guides for easy implementation

Recorded, available at any time


Learning from Recent Warning Letters related to Part 11 and Computer Validation

With Clear Recommendations for Corrective and Preventive Actions

Recorded, available at any time


Transfer of Analytical Methods According to New FDA, USP and EU-GMP Guidelines
With SOPs, templates and examples for easy implementation
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 the New FDA Data Integrity Guidance
With examples and procedures for effective implementation

June 22, 2017


Contingency and Disaster Recovery Planning for Computer Systems
To Ensure Business Continuity and Compliance
June 26, 2017


Analytical Instrument Qualification According the new Revision of
USP <1058>

With SOPs, Templates and Examples for easy Implementation
Recorded, available at any time


FDA/EU Compliant Handling of OOX Test Results

Learn how to investigate out-of-trend (OOT) and out-of-expectation (OOE) vs. OOS results



Understanding Quality by Design for the Pharmaceutical Industry

Introduction to Principles, Regulatory Activities and Industry Practices

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



with 10+ validation  examples, seminar with FDA's Dennis Cantellops and Ludwig Huber and with 13 SOPs for easy implementation.




December 2017

ICH Publishes Q12 for Pharmaceutical Lifecycle Development

The Guidance with the full title "The Technical and Regulatory Considerations for
Pharmaceutical Product Lifecycle Management" has been endorsed  by the members of the ICH assembly under Step 2 and release for public consultation. This guideline applies to pharmaceutical drug substances (i.e., active pharmaceutical ingredients) and pharmaceutical drug products, including marketed chemical, and biotechnological/biological products. The guideline also applies to drug-device combination products that meet the definition of a pharmaceutical or
biotechnological/biological product. Changes needed to comply with revisions to
Pharmacopoeial monographs are not in scope of this guideline. An effective Pharmaceutical Quality as described in ICH Q10 and compliance with regional
GMPs are necessary for implementation of this guideline.The guideline can be downloaded from the ICH website.

MHRA publishes GDP Inspection Deficiency Data 2016

The GDP Inspectorate has reviewed the GDP inspection deficiency data for 2016 to allow identification of:
• severity and frequency of deficiencies associated with EU GDP references
• high impact and high frequency issues.

Quality systems appeared to be the most common GDP deficiency in 2016.
A comparison of inspection year 2016 against 2015 has not been conducted due to
changes made to the regulatory requirements for GDP in 2013. Until a full inspection cycle has been achieved, any identified trends may appear misleading. Only Major findings against GDP are included in the detailed review of deficiencies. These represent common, significant threats to patient health and product quality. Critical deficiencies were excluded as they generally cover broader sections of the GDP guidelines and are assessed individually due to the seriousness of issues
Examples for deficiencies:
- The scope of Management Reviews did not include deviation analysis and there was no visibility of deviation detail at Management Review level.
- There was little or no evidence of the effective implementation of change control, risk management, deviation capture, CAPA reporting or management review
- Self-inspection had not been performed to the frequency defined in the company
The complete report can ne downloaded from the MHRA website

New FDA Draft Guidance for the Development of Drugs using Nanomaterial

This document provides guidance on the development of human drug products, including those hat are biological products, in which a nanomaterial is present in 49 the finished dosage form. This guidance focuses on considerations relevant to FDA’s regulation of these drug products under the Federal Food, Drug, & Cosmetic Act (FD&C Act) and Public Health Service Act (PHS Act), and includes recommendations for applicants and sponsors of investigational, premarket, and postmarket submissions for these products. The draft guidance discusses both general principles and specific considerations for the development of drug products containing nanomaterials, including considerations for establishing the equivalence of such products with other drugs. Considerations for quality,nonclinical, and clinical studies are discussed as they relate to drug products containing nanomaterials throughout product development and production. This draft guidance also includes recommendations on the specific content of applications for products containing nanomaterials where the nanomaterial is present in the finished dosage form. The guidance is availble for download from the FDA website.

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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.