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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

 

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 the 'New' FDA Guide for Validation of Bioanalytical Methods
With SOPs, templates and examples for easy implementation
February 13, 2014 

 

FDA/EU Compliant IT Infrastructure and Network Qualification

With Strategies and Tool Kit for Compliance and System Uptime

February 20, 2014

 

Validation and Use of Cloud Computing in FDA Regulated Environments

Comply with GXPs, Part 11, EU Annex 11 and other regulations

March 27, 2014

 

Laboratory Equipment Calibration and Qualification according to USP <1058>

With SOPs, Templates and Examples for easy Implementation

March 27, 2014

 

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.

 

 

 

USP proposed to Revise the General Chapter <1092> on Dissolution

The USP General Chapters - Dosage Forms Expert Committee has proposed to revise General Chapter <1092> The Dissolution Procedure: Development and Validation. The proposed revision will include additional information on:
1) Preliminary assessments needed before initiating procedure development, 
2) Automation, and 3) Acceptance criteria and interpretation of results from a dissolution test..A companion Stimuli article explains the rationale and content of this proposed revision. General Chapter <1092> and the associated Stimuli article have been published in Pharmacopeial Forum 40(1).  Source: USP Notices.

EMA Releases Inspectional Information on GMP Issues

Whenever Labcompliance reported about FDA inspection reports such as 483 form inspectional observations, establishment inspection reports and warning letters we have been asked if similar information is available from Europe. Besides a few individual reports presented at conferences by EU inspectors there was no structured information available from Europe. This has changed now. IThe European Medicines Agency (EMA) has launched a new version of the EudraGMDP database which includes the publication of statements of non-compliance with GMP. Regulatory authorities conduct inspections of manufacturing sites and issue GMP certificates when they conclude that a site is GMP compliant. When inspectors conclude that a site is not GMP compliant, a statement of non-compliance with GMP is issued and regulatory authorities enter the document in EudraGMDP. These non-compliance documents are now publicly accessible as well as the positive GMP certificates. The data base includes information on the nature of the non-compliance and the actions taken or proposed by the issuing authority in order to protect public health. More information is available on the EMA website.

FDA and EMA launch Generic Drug Application Inspection Initiative

The U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced the launch of a joint initiative to share information on inspections of bioequivalence studies submitted in support of generic drug approvals. This collaborative effort provides a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies. This is another good step towards global harmonization of inspections. To read the FDA press release with more details about the impact of this initiative on inspected companies click here

New presentation on "Future Activities of ICH from the FDA Point of View"

The topic was presented at the Annual DIA Japan meeting on November 7, 2013, by Theresa Mullin, PhD, FDA's director of the Office of Strategic Program, CDER. Dr. Mullin recommended preserving four strengths of ICH on approaching the future:  commitment of significant staff resources, commitment to ICH meetings, commitment to implementation of ICH guidelines and commitment to of resources to help train others to enable implementation of ICH guidelines. The presentation can be viewed and downloaded from the FDA website.

Labcompliance Introduces the New Network Compliance Package

The package has been updated with a seminar and good practice guides for qualification of virtual infrastructure. It now includes 28 SOPs, a primer and a network qualification plan. It also comes with 13 examples/checklists, three audio seminars and two years free online updates. FDA and international agencies require network infrastructure to be formally qualified and tested. The package helps to develop strategies for network qualification and it has the tools for trouble free implementation. For details on content and ordering, click here.

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 Best Practice Document "SOP: Handling Out-of-Specification Results". To download your free copy, go to the Laboratory Compliance Package website. Scroll down and click on the corresponding ICON on the left (offer expires on February 10 , 2014). Labcompliance offers more than 150 SOPs and other documents that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

Audio Seminar Schedule

  1. Understanding the 'New' FDA Guide for Validation of Bioanalytical Methods
    With SOPs, templates and examples for easy implementation
    February 13, 2014
  2. FDA/EU Compliant IT Infrastructure and Network Qualification
    With Strategies and Tool Kit for Compliance and System Uptime
    February 20, 2014
  3. Validation and Use of Cloud Computing in FDA Regulated Environments
    Comply with GXPs, Part 11, EU Annex 11 and other regulations
    March 27, 2014
  4. Laboratory Equipment Calibration and Qualification according to USP <1058>
    With SOPs, Templates and Examples for easy Implementation
    March 27, 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.