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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

 

Five 2-day In-person Interactive GMP, Part11 and Validation seminars available in America, Europe and Asia delivered by Dr. Ludwig Huber.   

 

Now with Qualification of Virtual Networks

With three audio seminars

With 28 SOPs

 

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

 

Understanding the 'New' FDA Guide for Validation of Bioanalytical Methods
With SOPs, templates and examples for easy implementation
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

April 17, 2014

 

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.

 

 

 

Lab equipment failures must be  investigated, FDA Warning letter says

FDA expects to record laboratory equipment failures with adequate follow-up. This became obvious in a recent inspection followed by a warning letter.  The letter reads: Deviations pertaining to laboratory equipment failures were not investigated. During the review of the service report log books for HPLC and GC units, the investigator found many instances of servicing due to instrument problems that were not documented as deviations.  According to your SOP, all service activities for equipment, including laboratory instruments, need to be documented as deviations. Your response stated that the SOP has been changed to require deviations only for instances in which servicing was required to repair a problem with the instrument. Your response failed to address why no deviation was filed and investigated for the instances in which instrument problems were the cause of system maintenance. The Warning Letters can be downloaded from the Labcompliance Usersclub. Scroll down to W-286. Non members can preview excerpts. Recording of equipment failures and other deviations and adequate follow-up such as investigations, repairs and requalification are part of the USP <1058> requirements. To learn everything about FDA's and USP's expectation for laboratory equipment attend the new Labcompliance audio seminar Laboratory Equipment Calibration and Qualification according to USP <1058>

New revision of the EU-GMP Annex 15 on Validation and Qualification

The Annex has been published as draft by the European commission for consultation. .The scope of the new Annex is quite comprehensive. It applies to all types of validation, e.g.,process, equipment, cleaning, transportation, utilities, and requalification, Besides of the extended scope the revision was necessary to be in line with related modern documents such as ICH Q8-11. For example, the new Annex uses terminology from Quality-by-Design approach as described in Q8, from risk assessment in Q9 and from the lifecycle concept with continuous monitoring and improvement as described in Q10. Special emphasis is put on the availability of a validation master plan with very specific requirements for contents So there are a lot of new requirements and  a lot to learn.  All this will be covered in the new seminar from Labcompliance: Understanding the New EU-GMP Annex 15 on Validation and Qualification - New requirements and strategies for implementation. The guide is available for download on the EC website.

FDA releases a New Draft Guidance on "Analytical Method Validation"

Once final the new guidance with the title: Analytical procedures and methods validation for drugs and biologics" will replace the current draft guidance from 2000 and it will also replace the 1987 guidance on Submitting Samples and Analytical Data for Methods Validation. The recommendations apply to drug substances and drug products covered in new drug applications, abbreviated new drug applications and biologics license applications.  Opposite to the earlier 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). It will be interesting to see how the industry will react to the requirement that  development data within the method validation section should be submitted to the FDA if they support the validation of the method. The guidance is available for viewing and download from the FDA website. To learn everything about new FDA requirements for validation of analytical procedures and methods, attend the new Labcompliance seminar "Validation of Analytical Methods according to the New FDA Guidance"

Updates on Using Cloud Computing in Regulated Environments

Cloud computing can significantly reduce investment and operating costs for IT operations. However when used in FDA and other regulated environments they need to be validated to ensure consistent on-going performance and security and integrity of stored and managed data. While there are guidelines available on how to deal with standard networks and computer systems this is not the case for virtual  networks and cloud computing. The topic is discussed in a new Labcompliance Audio seminar.  During the seminar, the speaker will present strategies and an overview and give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation

"Quality by Design" is getting more and more important for Pharma

While the concept of QbD has been used in many industries since the last century and FDA has been promoting QbD since the beginning of this century it is only recent that the majority of the pharma industry plans implementing QbD in development and quality control. One of the reasons for this trend is that most recent guidelines from FDA, EMA, ICH and USP suggest using components of QbD. Examples are the EU GMP Annex 15 on Qualification and Validation, the new FDA guide on Validation of Analytical Methods, the new ICH Q3D guideline on Elemental Impurities and USP's Pharamacopeia Forum stimuli article on Lifecycle Management of Analytical Procedures: Method Development, Procedure Performance Qualification, and Procedure Performance Verification. In addition, the FDA. and EMA have just announced to extend their pilot program for parallel assessment of quality-by-design applications for two years demonstrating the commitment of both agencies for QbD. Despite of all these initiatives the industry still has difficulties to fully understand the concept. In line with this situation Labcompliance offers a seminar entitled:  Understanding Quality by Design for the Pharmaceutical Industry,  In one hour the seminar provides an Introduction to Principles, Regulatory Activities and Industry Practices of QbD. 

Audio Seminar Schedule

  1. Validation and Use of Cloud Computing in FDA Regulated Environments
    Comply with GXPs, Part 11, EU Annex 11 and other regulations
    Available on demand at any time with all reference material
  2. Laboratory Equipment Calibration and Qualification according to USP <1058>
    With SOPs, Templates and Examples for easy Implementation
    Available on demand at any time with all reference material
  3. Understanding the New EU-GMP Annex 15 on Validation and Qualification
    New requirements and strategies for implementation
    Available on demand at any time with all reference material
  4. Understanding Quality by Design for the Pharmaceutical Industry
    Introduction to Principles, Regulatory Activities and Industry Practices
    Available on demand at any time with all reference material
  5. Validation of Analytical Methods according to the New FDA Guidance
    Understanding FDA's New Lifecycle Approach Towards Method Validation
    Available on demand at any time with all reference material
  6. Impact of Quality by Design on the Analytical Laboratory
    Learn through examples on development and validation of analytical procedures
    Available on demand at any time with all reference material

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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.