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Validation and Use of Excel® Spreadsheets in Regulated Environments

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

Recorded

 

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

 

FDA Compliance for Biopharmaceutical Laboratories

Become familiar with FDA regulations and get tool kits for implementation

Recorded, available at any time

 

Understanding the New USP Chapters 232/233 for Metal Impurities

With SOPs and Case Studies for Easy Implementation

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

 

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, June 2011

FDA Warning Letters increasing by 30% in FY 2011

According to an article published by FDA News FDA has already issued 874 warning letters in fiscal 2011, compared with 673 last year. This is an increase of 30%. According to an earlier Labcompliance News article inadequate laboratory laboratory controls have been #1 deviations in FY 2010. according to the Labcompliance analysis of FDA GxP related warning letters, a similar trend is expected for 2011.

Periodic Evaluation and Review of Computer Systems Legally Required

Since quite some time periodic review of computer systems has been suggested by industry task forces such as GAMP and regulatory guidance such as the PIC/S Good Practices Guide for computer systems used in regulate GxP environments. GMP. Also the FDA expects a periodic evaluation and review to ensure that a system, once validated, remains in a validated state. And periodic review of computer systems becomes a legal requirement for the European market after July 1, 2011. Chapter 11 of the new EU GMP Annex 11 reads: Computerized systems should be periodically evaluated to confirm they remain in a valid state and are compliant with GMP.   Attend the new Labcompliance audio seminar to learn everything about regulatory expectations and effective implementation of periodic evaluation and review.

FDA Expects to Validate or Verify the Accuracy of Bioanalytical Methods

FDA GLP regulations do not specifically spell out the requirement for validation or verification of methods used for preclinical studies.  However FDA expects that laboratories have documented evidence that such methods are suitable for intended use. FDA and EMA have developed guidance documents for validation of bioanalytical methods targeted to clinical and preclinical studies. And FDA inspectors check proper method performance during inspections. An example is a warning letter that was issued after a GLP study inspection. The letter reads statements such as: "FDA found that SNBL failed to use quality control samples in toxicokinetic assays to ensure quantitative accuracy of the bioanalytical method" and "Study Directors failed to ensure that bioanalytical methods used in nonclinical laboratory studies were accurate". and "There is no assurance the Study Director records and verifies the accuracy of bioanalytical methods used in nonclinical safety studies. The Warning Letter can be downloaded from the Labcompliance Usersclub. Scroll down to W-244. Non members can preview excerpts. To learn everything about validation of bioanalytical methods, attend the audio seminar  "Validation of Bioanalytical Methods and Procedures".

New FDA Guidance about Enforcement of Safety Reporting Requirements for INDs and BA/BE Studies

This document provides guidance to sponsors and investigators on enforcement of FDA’s final rule, “Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans” (75 FR 59935, September 29, 2010). This guidance contains information regarding the Agency’s intent to exercise enforcement discretion regarding the reporting requirements in the final rule until September 28, 2011. The guidance can be downloaded from the FDA website

Shares fall 5 Percent Caused by an FDA GMP Warning Letter

The warning letter has been received after an FDA inspection in December 2010 and January 2011. The specialty pharmaceutical company failed to comply with requirements for sampling and testing of in-process materials, for handling out-of-specification situations and production record review. According to a note from a security analysts the warning letter does not affect the company's manufacturing and shipment of approved products, but could cause FDA to withhold approval of pending applications. For the complete article, click here. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-252.

Part 11 Related Deviations Cited in  FDA Warning Letter

As part of the ongoing Part 11 inspection program FDA inspections continue to focus on Part 11 requirements. This became obvious in a recent warning letter going to a pharmaceutical manufacturer. The company used a computer system to control setpoints and to monitor records from equipment, room differential pressure, room humidity, and stability chambers.  The system was password protected but all employees had access to the room where the computer system was located. The problem was that all employees entering the room could disconnect an external hard drive, and change data and delete data without a password and resave on the computer system without leaving a trace. The Warning Letter can be downloaded from the Labcompliance Usersclub. Scroll down to W-253. Non members can preview excerpts. To learn everything about FDA's s, on-going Part 11 inspection program and other recent warning letters attend the audio seminar  "How to Prepare Yourself for FDA's on-going Part 11 Inspection Program".

FDA Publishes Names and Addresses of Inspected Facilities

As part of its Transparency Initiative the FDA published names and addresses of all facilities that have been inspected in FY 2009 and 2010. The data also include the products that the facilities produced and the inspectional classification: No action indicated (NAI), voluntary action indicated (VAI) or official action indicated (OAI). The data are published as an Excel spreadsheet that can be viewed and downloaded from the FDA website.

Approvals for Biopharmaceuticals nearly doubled in the past Decade

Compared with the 1990s the regulatory approvals of biopharmaceutical medicines in the United States have nearly doubled. FDA approved 65 new biopharmaceuticals between 2000 and 2009, up from 39 approvals during the 1990s, and 13 in the 1980s. According to a report from the the Tufts Center for the Study of Drug Development, there are also some challenges, for example, the average combined clinical and approval phase time for biopharmaceuticals rose to 95 months during the 2000s, up from 77 months in the 1990s. The full article has been published by Biopharm. Compliance issues may be one of the reasons for the delay. Attend the new seminar FDA Compliance for Biopharmaceutical Laboratories to learn everything about FDA and international requirements.

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 "Revalidation of Software and Computer Systems". To download your free copy, go to the Macro and Spreadsheet Quality Package website. Scroll down and click on the corresponding ICON on the left (offer expires on July 1 , 2011). Labcompliance offers more than 130 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

Audio Seminar Schedule

  1. Validation of Bioanalytical Methods and Procedures
    Conduct and Document for Efficiency and FDA&EMA Compliance
    Recorded
  2. 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
  3. Periodic Review and Evaluation of Computer Systems
    With strategies and tools for FDA and EU compliance
    Recorded, available at any time
  4. Understanding the New USP Chapters 232/233 for Metal Impurities
    With SOPs and Case Studies for Easy Implementation
    Recorded, available at any time

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