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

 

Ensuring Integrity and Security of Laboratory Data

Comply with new FDA inspection practices and EU Annex 11 requirements

Recorded, available at any time

 

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

 

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, 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, available at any time

 

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

 

Transfer of Analytical Procedures According to the New USP Chapter <1224>

With SOPs, templates and examples for easy implementation

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

 

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, July 2011

USP: Current and Future Directions

Anthony J. DeStefano, Ph.D., Vice President, General Chapters, US Pharmacopeia, gave an interesting presentation with overview on USP directions. The presentation also outlines the USP organization and which expert committees exist. In addition Dr. DeStefano explains the meaning of general chapters with numbers below and above 1000, how general chapters are developed and the relationship to general notices and monographs. USP's harmonization efforts has been demonstrated using the update of general chapter <621> as an example. As of July 2011 the presentation is available on-line.

FDA Update on Part 11

George Smith who heads up FDA's Part 11 working group gave an update on FDA's Part 11 activities at the DIA 2011 conference in Chicago. The presentation included history and current state of Part 11, an update on the FDA's Part 11 inspection assignments, areas of FDA's concern and misinterpretation and inspectional observations. Mr. Smith also talked about possible outcomes of the program and next steps. One of the key points was that currently there is no foreseeable end time, so inspectors most likely will look at computer systems and electronic records over the next months. The presentation is included in the reference material of the seminar material "How to prepare yourself for FDA's on-going Part 11 Inspection Program and is also available to Usersclub Members. To preview the site, click here.

GMP Annex 11 enforced since July 1

The EU GMP Annex 11 for using computers  in GMP environments has been published in January this year with a grace period until June 30. This Annex 11 mandatory for all organizations marketing drugs and other medicinal products to Europe.  Together with the updated EU GMP Chapter 4 on documentation it is the EU equivalent to FDA's Part 11. It addresses the regulatory needs of modern IT equipment and when implemented right, also has business benefits through reduced failure rates. The document is a good framework for validation and using computer systems and handling electronic records in different regulated environments. On the other hand it leaves a lot of room for interpretation that raises lots of questions. Sign up for the Labcompliance audio seminar to learn everything about the new release of Annex 11 and EU GMP Chapter 4 and receive 10+ best practice for easy implementation. 

Response to 483 after 15 business days declined by FDA

Companies receiving a 483 inspectional observation are advised to respond within 15 business days.  A good response can influence FDA's decision to issue a warning letter or not. Responses sent later than 15 business days are not considered any more for issuing warning letters. Details can be found in a warning letter from April 2011. The inspection was finished on August 26, 2010. Written responses dated September 23 and later have not been considered by the FDA when writing the warning letter. "We (FDA) acknowledge your written responses, dated September 23, 2010, October 11, 2010, October 28, 2010, and December 16, 2010, to the Form FDA 483. However, because these responses were received more than 15 business days after the Form FDA 483 was issued; these responses have not been considered. We plan to evaluate your additional responses to the Form FDA 483, along with any other written material provided, as a direct response to this Warning Letter. The Warning Letter can be downloaded from the Labcompliance Usersclub. Scroll down to W-253. Non members can preview excerpts.

FDA Introduces a Spectral Library to Detect Improper Ingredients in Drugs

Globalization of the pharmaceutical supply chain has increased the challenges to FDA to ensure that drug products and ingredients are not contaminated, counterfeited, or mislabeled. To help in this effort, the agency has developed rapid screening methods for pharmaceutical products and ingredients that can be deployed on portable instruments by field laboratories and inspectors for the screening of dietary supplements, pharmaceutical ingredients, and finished products on site (e.g., at border crossings, import centers, foreign manufacturing sites. During the past year, FDA's Division of Pharmaceutical Analysis (DPA) has developed a deeper understanding of the value and limitations of library-based Raman and NIR spectral-correlation methods for rapid spectroscopic screening of pharmaceutical ingredients. DPA would now like to build an excipient library to be deployed on NIR and Raman portable instruments and used at points of entry or storage. The full article has been published by Pharmaceutical Technology (PT). This article provides details on how to participate, and some anticipated questions and answers. As of July 2011 the article is available on the PT website. Copyright rests with the publisher.

New Article on Quality Risk Management Principles With Case Studies

Recognizing the need to propagate and expedite holistic adoption of quality risk management across the pharmaceutical industry, about a year ago the Product Quality Research Institute Manufacturing Technology Committee (PQRI–MTC) commissioned a small working group of industry and FDA representatives to seek out good case studies of actual risk-management practices used by large bio/pharmaceutical firms to share with the industry at large. The working group shared its experience in an article published by Pharmaceutical Technology. As of July 2011 the article is available on the PT website. Copyright rests with the publisher. For other articles from Pharmaceutical Technology, 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 SOP "Handling Security Patches". To download your free copy, go to the Network Quality Package website. Scroll down and click on the corresponding ICON on the left (offer expires on August 15 , 2011). Labcompliance offers more than 130 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

Conference

Audio Seminar Schedule

  1. Understanding the New USP Chapters 232/233 for Metal Impurities
    With SOPs and Case Studies for Easy Implementation
    Recorded, available at any time
  2. Verification of Compendial Procedures according to the Updated USP Chapter <1226>
    Understand the new risk based approach and and get real world case studies for testing
    Recorded, available at any time Recorded,

 

New or Updated Sites

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