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Sept 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
September 1, 2015

- 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

 

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.

 

 

 

"Training Materlal not available in local Language", cited in  FDA Warning Letter

The warning letter states: "During interviews with our investigators, your contract employee was unable to explain the material he was required to present during training. In addition, while a significant number of your contract employees do not speak English, you only provided English training materials to these employees." 
The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 302).  To learn everything about FDA expectations for training, attend the Labcompliance audio seminar "Efficient Training Practices for FDA and International Compliances".

New Version 4.0 of the ISO 17025 Accreditation Package Released

On December 16 Labcompliance has released a new major revision of the popular ISO 17025 Accreditation package. The new version includes 8 new SOPs, an updated quality manual,  an updated step-by-step implementation plan, a new tool kit for estimating costs and timing for implementation. In addition most other key documents have been updated to reflect most recent recommendations from official accreditation committees and laboratory quality system experts. With the new additions the package includes 51 SOPs for chemical testing and 38 SOPs for mechanical, optical and electronic testing and calibration laboratories.  For additional information and ordering, click here

ICH develops Training Material for ICH Q3D

ICH plans to to establish a working group to prepare a comprehensive training program and associated materials to facilitate an aligned interpretation and a harmonized implementation of ICH Q3D in the ICH and non-ICH regions. More details such as the background of the proposal, statement of the perceived problem, issues to be resolved, training contents, the type of working group and timing can be found in a concept paper and business plan.

Part 11 requires Recording and Maintaining "Complete" Records

FDA requests regulated records to be accurate and complete. The guidance on Part 11 scope and Applications requires records to preserve the content and meaning. Incomplete records or incomplete raw data are frequent citations in Warning Letters. A recent example is a warning letter for a drug manufacturer: "Failure to maintain complete data derived from heavy metals analysis and residual solvent analysis. For example, the names of analysts performing those tests, and the names of a second person to review the results and to ensure conformance with established specifications and standards are missing" This is a data integrity issue. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 302).  To learn everything about FDA expectations to ensure data integrity study the Laboratory Data Integrity Package and in the 2-day interactive seminar "Validation and Part 11/Annex11 Compliance of Computerized Analytical Systems and Data", with focus on data integrity. TheLaboratory Data Integrity Packag, .

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 Best Practice Document "SOP: Quality Assessment of Software and Computer System Suppliers". 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 December 15, 2015). Labcompliance offers more than 150 SOPs and other documents that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

Four New Class-Room Trainings with Dr. Ludwig Huber in Zurich and San Francisco

Dr. Ludwig Huber will conduct four 2-day public seminar seminars on Analytical Instrument Qualification and System validation, on Computer System Validation and Part 11 Compliance and on Validation and Transfer of Analytical Methods. The trainings are organized by ComplianceOnline and will be delivered as workshops and interactive discussions. Attendees will receive 20+ good practice guides such as SOPs, validation examples and templates for easy implementation.

Here are the dates and locations

Advanced notice

  • Validation and Part 11 Compliance of Computer Systems and Data
    2-Days seminars in Sydney, Mumbai and Hong Kong in April 2016, stay tuned

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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.