Home | Contact Us | Newsletter | Usersclub | Books | Audio Seminars


 

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

 

 

FDA/EU Compliant Training for Laboratory Personnel

What to train - How much to Train - How to Document Effectiveness

Recorded

 

Implementing the New USP Chapter <1224> for Analytical Method Transfer

With SOPs, templates and examples for effective implementation

March 15, 2012

 

Quality by Design (QbD) for  Development and Validation of Analytical Methods
Learn how to design robustness for easy transfer and to avoid OOS situations
Recorded

 

Qualification of Virtual Networks and Cloud Computing

With Strategies and Tool Kit for Compliance and System Uptime
Recorded

 

Verification of Compendial Methods according to the New USP Chapter <1226>
Understand the new risk based approach and  get real world case studies for testing
Recorded, available at any time

 

Validation and Use of Excel® Spreadsheets in Regulated Environments

Comply with Part 11, PIC/S and Annex 11.

Recorded, available at any time

 

Periodic Review and Evaluation of Computer Systems

With strategies and tools for FDA and EU compliance

Recorded

 

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

 

Raw Data in FDA Regulated Environments

FDA/EU compliant recording, maintenance and archiving

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

 

Development and Validation of Stability Indicating Methods for FDA/ICH Compliance

Sample generation - method development - validation - documentation

Recorded, available at any time

 

FDA Compliant Use of (Certified) Reference Material

With 10+ Best Practices for easy Implementation

Recorded

 

Effective HPLC Method Development and Validation

Preparation, conduct and documentation for FDA/EMA Compliance

Recorded

 

Analytical Instrument Qualification According to USP <1058>

With SOPs, Templates and Examples for Easy Implementation

Recorded

 

 

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

 

 

Labcompliance News January 2012

Joint EMA and FDA Inspections starting in January

The European Medicines Agency and the United States Food and Drug Administration (FDA) are launching an initiative to share work on inspections of manufacturing sites in each other's territories. The initiative, starting in January 2012, will enable the two authorities to rely on each other's inspection outcomes rather than carrying out separate inspections in duplicate. This is expected to enable better use of the two authorities' inspection resources; reduce the burden of inspections for medicines manufacturers; and shift the authorities' inspection capacity to other regions. For more information, click here.

Free E-Books on Cloud Computing and Virtualization of Networks

Cloud computing and virtualization of computers and networks can be quite attractive for organizations to reduce overall costs. For everybody who want to learn about these technology and benefits we recommend two e-books that as of Jan 2012 can be be ordered at no charge through the Web. The titles are: "The Definitive Guide to Virtual Platform Management" and "The Definitive Guide to Cloud Computing" from Realtime Publishers. The questions still is: What does it mean for the FDA and other regulated industries?  Does the FDA and other agencies allow the use of virtual networks and cloud computing?  And  if so; what about validation? And what about Part 11 Compliance? Attend the Labcompliance seminar "Qualification of Virtual Networks and Cloud Computing" to get a good overview on issues and solutions and get 10+ good practice guides for implementation.

Product Recalls and Temporary Manufacturing Halt after FDA Inspection

As a result of an FDA inspection with a 13-item 483 inspectional observation a global pharmaceutical company temporarily halted manufacturing in its OTC plant in December 2011. Later on the company also  announced voluntary recalls of certain lots of OTC products manufactured at the same site. .During an inspection in summer 2011 Novartis FDA noticed that the company has failed to adequately investigate 166 complaints of foreign tablets in bottles since 2009. Other observations included: Responsibilities and procedures applicable to quality control unit not followed, inadequate failure investigations, failure investigations not extended to other batches, batch record did not include all required information, deviations from written procedures not recorded and justified, inadequate procedures for complaint handling, insufficient frequency of GMP training The 483 can be downloaded from the Labcompliance Usersclub. Scroll down to W-263. Non members can preview excerpts.

FDA Publishes Updated ANDA Checklist

The checklist has been published in December 2011 as the fifth revision after initial publication in January 2011,. The list is quite useful in preparation for Abbreviated New Drug applications to ensure completeness and acceptability of the application.  As of January 2012 the checklist can be downloaded from the FDA Website.

FDA Expects Robustness Testing during Method Validation

It became clear from a recent warning letter that FDA expects robustness testing to be included in validation studies. For example, the impact of chromatographic column batch-to-batch variability on peak resolution  should be studied. The letter states "Failure to validate analytical test methods used for API for potency testing. For example, your firm failed to validate the xxx compound to quantify Peak A for potency and robustness. Your firm has been unable to determine why the chromatographic columns of the same make and model had variability and could not provide adequate separation", Other deviations included: Inadequate or lack of an investigation of critical deviations, responsibility of Quality Control Unit not established and inadequate response to failure investigations. The Warning Letter can be downloaded from the Labcompliance Usersclub. Scroll down to W-259. Non members can preview excerpts. To learn everything about FDA's expectation for validation of analytical methods and to build robustness into a method through Quality by Design (QbD), attend the Labcompliance audio seminar and receive 10+ best practice guides for easy implementation

USP <1224> on Transfer of Analytical Procedures official in May 2012

USP Chapter <1224> was approved in June 2011. It will be official in USP 35 (May 1st 2012). The chapter presents for options for controlled transfer and recommends the risk based approach for transfer studies.  Register for the Labcompliance audio seminar "Implementing the New USP Chapter <1224> for Analytical Method Transfer" to learn everything about the new chapter and receive 10 best practice guides, e.g., SOPs, examples and checklists.

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 , 2012). Labcompliance offers more than 130 SOPs and other documents that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

 

Audio Seminar Schedule

  1. Quality by Design (QbD) for  Development and Validation of Analytical Methods
    Learn how to design robustness for easy transfer and to avoid OOS situations
    January 26, 2012
  2. Qualification of Virtual Networks and Cloud Computing
    With Strategies and Tool Kit for Compliance and System Uptime
    February 9, 2012
  3. FDA/EU Compliant Training for Laboratory Personnel
    What to train - How much to Train - How to Document Effectiveness
    February 16, 2012
  4. Implementing the New USP Chapter <1224> for Analytical Method Transfer
    With SOPs, templates and examples for effective implementation
    March 15, 2012

New or Updated Sites

Click here to tell others in your company about compliance news

 

Recent Warning Letters and 483's Related to Computer Validation and
Part 11
Labcompliance.com