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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

 

FDA Compliant IT Infrastructure and Network Qualification

With Strategies and Tool Kit for Compliance and Efficiency Recorded, available at any time

 

Implementing the New Final EU-GMP Annex 15 on Validation and Qualification
New requirements and strategies for implementation
Recorded, available at any time

 

Managing Electronic Raw Data in Regulated Environments
Definition, generation, evaluation and archiving for FDA, PIC/S and EU compliance
Recorded, available at any time

 

New Guidelines and Trends in Method Validation and Transfer

Comply with new FDA, EMA, USP and Industry Guidelines

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

 

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 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

 

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.

 

 

 

Highest FDA Concern: Missing availability and control of raw data

FDA continuous focusing on data integrity, especially on the availability of complete electronic and other raw data. A recent warning letter to an API manufacturer states:  "You did not retain complete raw data from testing performed to ensure the quality of your APIs. For example, your firm could not provide electronic raw data supporting your High Pressure Liquid Chromatography (HPLC) testing in your Validation Report. You failed to retain complete raw data documenting the weights and calculations used in method validation as specified in your standard operating procedure (SOP) “Recording of Raw Data. In addition, your laboratory systems did not have access controls to prevent deletion or alteration of raw data. During the inspection, your analysts demonstrated that they were given inappropriate user permissions to delete HPLC data files. selective system suitability test results discarded, unauthorized access to data, failure to review historical data to ensure the quality of your products distributed to the US market" The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 294).  To learn everything about FDA expectations for raw data, attend the Labcompliance audio seminar  Managing Electronic Raw Data in Regulated Environments

EU releases the new final version of the GMP Annex 15: Qualification and Validation

The new final Annex 15 on Validation and and Qualification has been released on March 30 and on October 1, 2015 will replace the existing version from 2001. The Annex has been significantly updated compared to the version of 20o1 but also compared to a draft version from 2014. The final Annex is in line with other modern related documents such as ICH Q8/9/10/11 and has components from Quality by Design,  Risk Assessment and Quality Systems, for example, continuous lifecycle management, and continuous  verification and improvements. EU GMP Annex documents have the status and effect of a regulation in Europe and will also be adopted as an Annex to PIC/S GMPs and used as inspection guide for PIC/S members such as US FDA, Health Canada and by many Asian agencies.  So everybody marketing APIs and drugs to Europe and to other PIC/S member countries should comply. On the other hand the new Annex has so many new requirements related to all types of validation and qualification that the industry needs guidance on how to implement. Attend the new Labcompliance Seminar to learn everything about implementing the new Annex.

FDA releases a New FDA Guidance on Near Infrared Analytical Procedures

This draft guidance provides recommendations to applicants of new drug applications  abbreviated new drug applications and drug master file (DMF) holders regarding the development and submission of near infrared (NIR) analytical procedures used during the manufacture and analysis of pharmaceuticals (including raw materials, in-process materials and intermediates, and finished products). It also provides recommendations regarding how the concepts described in the International Conference on Harmonization (ICH) guidance for industry Q2(R1) Validation of Analytical Procedures: Text and Methodology and PAT-A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance can be applied to the development, validation, and submission of NIR analytical procedures. The guidance can be viewed and downloaded from the FDA website.

FDA Warning Letter Requests Failure Investigations for a-typical Results

The warning letter states: "Your firm failed to conduct an investigation into unexplained discrepancies (atypical peaks) observed in the related substance assay results for multiple (b)(4) API batches ((b)(4)). During the inspection, the investigator noticed that the related substance chromatograms exhibited several unknown peaks. Your firm management did not know the source of these atypical peaks and had not initiated an investigation to document them. In response to this letter, describe the source of the atypical peaks detected in the related substance assays of the batches described above and in any other API distributed to U.S.". The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 287).  To learn everything about FDA expectations for atypical and other OOX results, attend the Labcompliance audio seminar FDA/EU compliant handling of OOX test results.

FDA approves first Biosimilar Product Zarxio

On March 6 the U.S. Food and Drug Administration approved Zarxio, the first biosimilar product approved in the U.S. Zarxio is biosimilar to Amgen Inc.’s Neupogen, which was originally licensed in 1991. Zarxio is approved for the same indications as Neupogen. For more info, read the FDA press release

Health Canada follows USFDA with focusing on data integrity

During recent inspections Health Canada has noted a number of issues in the areas of traceability (supply chain integrity), vendor qualification, cleaning validation, data integrity and packaging conditions and has taken compliance and enforcement actions, where appropriate. The integrity of data is an underlying expectation in the regulation of health products and establishments and any related issues have the potential to cause significant risk if not addressed. Data integrity issues have recently been noted in several facilities domestically and globally. Health Canada continues to monitor these issues and expects regulated parties to provide information as requested while also demonstrating how the integrity of data is ensured in their facilities as well as any facilities with which they are linked through contractual agreements. The full press release can be viewed on the Heath Canada website. To learn everything about FDA and  data integrity attend the seminar Data Integrity for FDA/EU Compliance.

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 "Validation of Spreadsheet Applicationsn". 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 April 30, 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

Ten 2-day

In-person Interactive GMP, Part11 and Validation seminars

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

For dates and detailed contents, click here.

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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.