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

With Quality Manual and  SOPs for easy implementation

 

New Usersclub Additions
last update
May 24, 2016

 

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

 

Understanding the Final FDA Guidance for Validation of Analytical Method

With 10+ best practice guides for easy implementation

July 14, 2016

 

FDA Compliant IT Infrastructure and Network Qualification 

With Strategies and Tool Kit for Compliance and System Uptime

Recorded, available at any time with all reference material

 

Understanding the New FDA Data Integrity Guidance
With examples and procedures for effective implementation
Recorded, available at any time with all reference material

 

Understanding the new Revision of USP <1058
With examples and procedures for effective implementation

Recorded, available at any time with all reference material

 

Integrity of Laboratory Data for FDA/EU compliance

Understand and implement data integrity through the entire data life cycle
Recorded, available at any time with all reference material

 

Quality by Design (QbD) for Development and Validation of Analytical Methods

With focus on conducting the risk assessment process

Recorded

 

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 with all reference material at any time

 

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

With Clear Recommendations for Corrective and Preventive Actions

Recorded, available at any time

 

Understanding the Final FDA Guidance for Validation of Analytical Methods

With 10+ best practice guides for easy implementation

Recorded, available at any time

 

Analytical Instrument Qualification According the new Revision of
USP <1058>
 

With SOPs, Templates and Examples for easy Implementation
Recorded, available at any time

 

Transfer of Analytical Methods According to New FDA, USP and EU-GMP Guidelines
With SOPs, templates and examples for easy implementation
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

 

Quality by Design (QbD) for Development and Validation of Analytical Methods

Learn how to design robust analytical for easy transfer and to avoid OOS situations

Recorded

 

FDA/EU Compliant Handling of OOX Test Results

Learn how to investigate out-of-trend (OOT) and out-of-expectation (OOE) vs. OOS results

Recorded

 

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

 

Understanding Quality by Design for the Pharmaceutical Industry

Introduction to Principles, Regulatory Activities and Industry Practices

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

 

Managing Electronic Raw Data in Regulated Environments

Definition, generation, evaluation and archiving for FDA, ICH, PIC/S and EU compliance

Recorded, available on demand

 

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.

 

 

 

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 new Labcompliance on-line seminar " FDA Compliant IT Infrastructure and Network Qualification" 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.

A year ago: FDA released the New Guidance on "Analytical Method Validation"

This final guidance with the title: Analytical procedures and methods validation for drugs and biologics" has been released in July 2015. After this grace period of one year the FDA is expected to ask related questions during upcoming inspections and to enforce it. Opposite to the 2000 guidance the new one includes sections on "Statistical analysis and models" and on "Lifecycle Management". The guidance refers to components used in the quality-by-design approach for analytical methods but does not state anywhere that validation must follow the QbD approach. For example, chemists are advised to follow the lifecycle management process, to begin with an initial risk assessment and follow with multivariate experiments (design of experiments).. To learn everything about new FDA requirements for validation of analytical procedures and methods, attend the new Labcompliance seminar Understanding the Final FDA Guidance for Validation of Analytical Method and receive 10+ best practice guides for easy implementation.  "

FDA's Concern about Using Actual Samples for System Evaluation Testing

FDA recommends avoiding “testing into compliance”, e.g., through using real product test sample for system readiness testing, and declare as official test run if the run is within product specification, otherwise declare it as test run and put the data in a special test folder. This behavior has been quoted in several FDA warning letter with the term: "trial sampling" or "trial injections", for example go to the fdawarning letter website, scroll down to W-302 and W-298.  Labcompliance recommends using three types of samples/standards:
a) System equilibration sample to check if the system is ready for system suitability test runs. This could be a standard mixture.
b) System suitability sample to check if the system meets system suitability test requirements as specified in USP chapter <621> and/or in your SOP. Use a standard or actual sample from different batch than the actual sample being tested,
c) Actual product test sample.
Labcompliance also recommends putting data of all three types of runs into the same folder

Tasks and timing of samples/standards (Source: Audio Seminar: Understanding the New FDA Data Integrity and CGMP Compliance Guidance )

Failure to Maintain Complete Data Cited In an FDA Warning Letter

 Records from analytical testing should be complete. to ensure compliance with CGMP, e.g., 21 CFR 211.194. According to an FDA warning letter the inspected company failed to record  record the name of the analysts performing the tests and the name of the second person reviewing the test results In addition, no heavy metal analysis was performed. Furthermore the company failed to investigate past shipments for incomplete test records and to properly maintain facilities and equipment. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 301). Attend the Labcompliance seminar "Integrity of Laboratory Data for FDA/EU Compliance" to learn everything about requirements for complete data.

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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.