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


 

Jan 2015

Version 4 just released

With strategies and tools for fast, cost-effective Laboratory Accreditation

With Quality Manual and  SOPs for easy implementation

 

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

 

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

 

Risk Based Validation of Computer Systems and Part 11 Compliance

With Strategies for FDA/EU Compliance and Tool Kits for effective implementation

Recorded, available at any time

 

Validation and Use of Cloud Computing in FDA&EU Regulated Environments

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

Recorded, available at any time

 

Ensuring Data Integrity for FDA/EU Compliance
Comply with FDA Part 11 and EU/PICS Annex 11 for paper, electronic and hybrid records
Recorded, available at any time

 

New OECD Guide: Using Computer Systems in GLP Studies

Understanding and Implementing the new OECD Guide for Computer Systems Recorded, available at any time

 

FDA Compliant HPLC Qualification and Performance Testing

Learn how to select, conduct and document the right tests in the right sequence

Recorded, available at any time

 

Managing Out of Trend Results in Pharmaceutical Quality Control

With Strategies and best Practice Guides for easy Implementation

Recorded, available at any time

 

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

With Clear Recommendations for Corrective and Preventive Actions

Recorded, available with all reference material at any time

 

FDA/EU Compliant IT Infrastructure and Network Qualification

With Strategies and Tool Kit for Compliance and System Uptime

Recorded, available at any time

 

Validation and Use of Cloud Computing in FDA Regulated Environments

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

Recorded, available at any time

 

Laboratory Equipment Calibration and Qualification according to USP <1058>

With SOPs, Templates and Examples for easy Implementation

Recorded, available at any time

 

Understanding the New EU-GMP Annex 15 on Validation and Qualification

New requirements and strategies for implementation

Recorded, available at any time

 

Understanding Quality by Design for the Pharmaceutical Industry

Introduction to Principles, Regulatory Activities and Industry Practices

Recorded, available at any time

 

Validation of Analytical Methods according to the New FDA Guidance

Understanding FDA's New Lifecycle Approach Towards Method Validation

Recorded, available at any time

 

Impact of Quality by Design on the Analytical Laboratory

Learn through examples on development and validation of analytical procedures

Recorded, available at any time

 

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.

 

 

 

New Primer on FDA Inspections and Warning Letters

This new 31-page primer entitled "Compliance by Design for Pharmaceutical Quality Control Laboratories" focuses on frequently cited GMP deviations observed during FDA inspections. Several hundred GMP-related Warning Letters and inspection reports were analyzed. Readers can use this information to educate themselves on the current thinking of FDA inspectors as well as on mistakes made by other companies and how to avoid them. Based on information from these citations, certain best practices have also been included that can help design regulatory compliance into quality control laboratories . The primer has been written by Dr. Ludwig Huber and published by Agilent Technologies. The primer is available from the Agilent website as PDF file.  

FDA publishes new Guidance on Current GMP Requirements for Combination Products

This guidance describes and explains the final rule on CGMP requirements for combination products (final rule as codified in 21 CFR part 4) that FDA issued on January 22, 2013. Prior to issuance of the final rule, although CGMP regulations were in place to establish requirements for drugs, devices, biological products, and Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), there were no regulations to clarify and explain the application of these CGMP requirements to combination products. The final rule was intended to provide such clarification and specify how compliance with applicable CGMP requirements may be demonstrated. The guidance is available on the FDA website for reading and download.

"Manual Reintegration must follow a documented Procedure", FDA says

When analyzing impurities in drugs and APIs by chromatography it frequently happens that automated peak integration is inaccurate. This may become obvious when looking at the default baseline settings. In this case analyst can use the manual integration feature of chromatographic data systems to correct the deficiencies. In several inspection reports the FDA made it clear that this manual reintegration must follow a company SOP to avoid a situation that reintegration is done for the sole or main purpose to bring out of specification test results into specification.  Examples are: "Your QC personnel perform peak integrations based on analysts’ experience rather than by an approved procedure. A QC operator interviewed during the inspection stated that integrations are performed and re-performed until the chromatographic peaks are “good”, but was unable to provide an explanation for the manner in which integration is performed (W-287)" and " Failure to have a written procedure for manual integration. Your firm made changes to integration parameters for the impurities test without appropriate documentation or justification (W-293)."  These citations are in line with FDA's ongoing focus on data integrity in quality control laboratories. In response to this Labcompliance has developed an Laboratory Data Integrity Package" that has training material and tool kits such was SOPs, checklists and examples to implement, document and  defend data integrity in your laboratory. For example, the package also includes an SOP for manual reintegration of chromatographic peaks.

FDA offers New Guidance Document Search Feature

A new feature on the FDA.gov website allows you to search for guidance documents for all topics across the site from one convenient location.
The site lists all official FDA Guidance Documents and other regulatory guidance. You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.

New FDA Guidance on Providing Regulatory Submissions in Electronic Format-Standardized Study Data


The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Providing Regulatory Submissions in Electronic Format—Standardized Study Data.” The guidance describes how FDA plans to implement the requirements for the electronic submission of standardized study data contained in certain submissions under new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs). This finalizes the revised draft guidance that was issued on February 6, 2014. For more information, 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 "Auditing Analytical Laboratories". To download your free copy, go to the ISO 17025 Accreditation Package website. Scroll down and click on the corresponding ICON on the left (offer expires on march 10, 2015). Labcompliance offers more than 170 SOPs and examples that help to comply with FDA and ISO 17025 compliance. For titles and ordering of the examples click here

 

Audio Seminar Schedule

In Person Seminar Schedule

Five 2-day

In-person Interactive GMP, Part11 and Validation seminars

available in America, Europe and Asia delivered by Dr. Ludwig Huber.
Locations: Singapore, San Diego, Boston, Philadelphia and Chicago.

For dates and detailed contents, click here.

New or Updated Sites

Click here to tell others in your company about compliance news

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.