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56 Usersclub Additions

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

 

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 FDA's New Guide on Use of Electronic Source Data in Clinical Investigations
With tool kit for cost effective 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

 

FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control

With Strategies and best Practice Guides for easy Implementation

 Recorded, available at any time

 

System Suitability Testing for FDA and USP Compliance

Setting parameters and limits for chromatographic and other methods

Recorded, available at any time

 

Analytical Equipment Qualification and System Validation for FDA Compliance

Combining the USP <1058> with the new GAMP(TM) Laboratory Computer Systems Guide

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 at any time

 

FDA Compliant Use of (Certified) Reference Material

Strategies for selection, purchasing, testing and documentation

Recorded, available at any time

 

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

 

Verification of Compendial Methods according to the Revised USP Chapter <1226>

Understand the new risk based approach and get real world case studies for testing

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

 

Validation of Bioanalytical Methods and Procedures

Conduct and Document for Efficiency and FDA&EMA Compliance

Recorded, available at any time

 

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 Control of Elemental Impurities by the European Pharmacopeia

The article written by Susanne Keitel  gives a brief overview of the European Pharmacopeia Commission's  decision to change its approach on elemental Impurities. According to the article the EP will be harmonized with current and future developments of the ICH Q3D guideline on the control of elemental impurities. As of December 2013 the article is available on the PharmTech website.  Copyright rests with the publisher.

Hong Kong SAR applied for PIC/S membership

The Hong Kong SAR's Pharmacy and Poison Board applied for PIC/S membership. The Rapporteurs for this accession have been appointed at the PIC/S Committee Meeting in October 2013 in Ottawa (Canada). To download the press release, click here. The pres release gives also an update on the status of other applicants. The Rapporteur in charge of the assessment of Brazil / ANVISA informed the Committee that the paper assessment of ANVISA was planned to start next year

10 New FDA Drug Inspectors Stationing in China

The FDA will soon add 10 drug inspectors to its office in China to help oversee drug and ingredient producers whose products make it into the U.S. supply chain, Bloomberg reports. China has become a key supplier for drugs made or exported here. The FDA had opened the first office in Cina in 2008 after being pilloried by outraged politicians when tainted Chinese heparin resulted in dozens of deaths in the U.S. The FDA has been trying for more than a year to add inspectors there but was stymied by the government. U.S. Vice President Joe Biden was able to get a final commitment during a visit to Beijing last week. Read more ...

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 "Electronic Audit Trail: Specifications, Implementation and Validation". 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 January 15, 2014). Labcompliance offers more than 120 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

Audio Seminar Schedule

  1. Understanding FDA's New Guide on Use of Electronic Source Data in Clinical Investigations
    With tool kit for cost effective implementation
    Recorded, available at any time

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.