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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

 

Good Laboratory Practice Regulations

Introduction and Strategies for Implementation

Recorded

 

IT Infrastructure and Network Qualification: Step-by-Step
With Strategies and Tool Kit for Compliance and System Uptime
October 18, 2011

 

Learning from Recent Warning Letters Related to Computer Validation and Part 11

With Clear Recommendations for Corrective and Preventive Actions

October 20, 2011

 

Cost Effective Computer System Validation: Step-by-Step

With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation

December 1, 2011

 

Validation of Analytical Methods and Procedures

Design, Conduct and Document for Efficiency and FDA Compliance

December 8, 2011

 

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

With Strategies and best Practice Guides for easy Implementation

December 15

 

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

With SOPs, templates and examples for easy implementation

Recorded, available at any time

 

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

 

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, September 2011

Health Agency helps Industry Preparing for an Initial Drug GMP Inspection

Health Canada has published a package that is useful in preparation for the submission of a Drug Establishment License Application for the activities of wholesaling, Importation and distribution. The package should ensure that industry establishments have the minimum requirements for GMP Compliance in place prior to inspections. The package includes an  inspection overview, table describing which regulations apply to each licensable activity to aid organizations in preparing for an inspection, checklists of minimum requirements that should be in place prior to the submission of drug establishment license application for each of the licensable activities and references to other applicable guidance documents and tools available. The information is also valuable in preparation for other GMP inspections. For example, the checklist with minimum requirements and a list of SOPs that should be available are generally applicable.  The package can be downloaded from the Health Canada website.

FDA Official Reports about Part 11 Related Inspectional Observations

During a recent presentation George Smith who heads up FDA's Part 11 working group gave several examples of recent Part 11 related observations. The intention was to show what kinds of observations have been seen in the past related to Part 11 controls in general and specifically related as part of FDA's on-going Part 11 inspection program. Observations have been related to protection of records, password controls, accurate and complete copies of records, limiting system access, validation, electronic signature controls and record retention. The presentation is included in the reference material of the seminar material  "Learning from Recent Warning Letters Related to Computer Validation and Part 11 and is also available to Usersclub Members. To preview the site, click here

"Failure to Provide Adequate Study Direction", cited in FDA Observation

 "All nonclinical laboratory studies must have a scientist or other professional with appropriate education, training, and experience as a study director." During a GLP inspections there were no records that clearly identified the study director, and those individuals actually conducting the studies did not fulfill all study director requirements including having overall responsibility for conducting the study and interpreting/reporting results. "There was no single point of study control". Furthermore the company failed "To have a Quality Assurance Unit, to provide adequate testing facility management, to maintain records for the maintenance and calibration of equipment, to maintain study documentation and to store materials in an orderly manner for expedient retrieval". The Warning Letter can be downloaded from the Labcompliance Usersclub. Scroll down to W-250. Non members can preview excerpts. To learn more about GLP Regulations  attend the audio seminar  "Good Laboratory Practice Regulations.

IT Infrastructure Qualification vs. Validation of Networked Systems

"IT infrastructure should be qualified and software applications should be installed on a qualified networked and validated". Dr. Huber gave this advice at a recent 90 minute interactive discussion session. He also explained in detail what  FDA and other agencies would expect, what IT infrastructure qualification includes, what measures are required to maintain infrastructure and networked systems in qualified and validated state and what documentation should be generated. . Most important is a rigorous configuration and change management system. Attend the Labcompliance on-line seminar " IT Infrastructure and Network Qualification: Step-by-Step" to learn everything about IT infrastructure and network compliance and receive 15+ best practice guides such as a network qualification plan, SOPs and a checklist.

USP Publishes Six New General Chapters on Spectroscopy Methods

USP has published new chapters on Atomic Absorption (<852>, <1852>), Mid-Infrared Spectroscopy (<854>, <1854>), and Ultraviolet-Visible Spectroscopy (<857>, <1857>). The new chapters are intended to replace the existing general <851> on Spectrophotometry and Light-Scattering. The new chapters have been split into mandatory chapters with numbers below 1000 and voluntary chapters with numbers above 1000. All new chapters have been published in the September/October issue of Pharmacopeial Forum that is available for free

Recent Warning Letter Related to 21 CFR Part 11

As part of the ongoing Part 11 inspection program FDA inspections continue to focus on computer systems and electronic records. 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 the 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 more about other recent Part 11 related warning letters attend the audio seminar  "Learning from Recent Warning Letters Related to Computer Validation and Part 11.".

First US FDA India Seminar on Computer System Validation & Part 11 Compliance a big Success

A a result of US FDA's focus on Computer Validation and Electronic Records during Drug and API GMP inspections there is an urgent need  for information on how to comply with current FDA requirements most efficiently. GlobalCompliancePanel, a training provider for FDA regulated industry did fill this gap for India through offering a related seminar in Mumbai, India, on Sept 15 and 16. The 2-day seminar was attended by 170 professionals from all over India and other Asian countries.  The seminar with many interactive discussions and workshop exercises was presented by. Dr. Ludwig Huber. For more information on content, the interactive format, on workshop sessions and on feedback from the audience, 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 "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 September , 2011). Labcompliance offers more than 130 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

Conferences

Audio Seminar Schedule

  1. IT Infrastructure and Network Qualification: Step-by-Step
    With Strategies and Tool Kit for Compliance and System Uptime
    October 18, 2011
  2. Learning from Recent Warning Letters Related to Computer Validation and Part 11
    With Clear Recommendations for Corrective and Preventive Actions
    October 20, 2011
  3. Cost Effective Computer System Validation: Step-by-Step
    With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation
    December 1, 2011
  4. Validation of Analytical Methods and Procedures
    Design, Conduct and Document for Efficiency and FDA Compliance
    December 8, 2011
  5. FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control
    With Strategies and best Practice Guides for easy Implementation
    December 15, 2011

New or Updated Sites

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