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


 

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

 

TFive 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

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

May 15, 2014

 

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.

 

 

 

FDA requests Operational Qualification for Analytical Laboratory Instrumentation

Analytical instruments in quality control laboratories are an on-going target of FDA inspections. This became obvious in a warning letter going to an API manufacturer. The warning letter reads: "Your firm has failed to conduct adequate qualifications of your analytical instruments and test equipment.  For example, the residual solvent method used to test xxx API has an initial starting gas chromatograph (GC) oven temperature of xxx.  Your firm’s current qualification of the GC oven temperature does not include temperatures below 100˚C.  All laboratory instrumentation and equipment that you use to test material manufactured for the U.S. market should have an Operational Qualification (OQ) and should be calibrated to include applicable operating ranges. Labcompliance recommends to follow the 4-Q (DQ, IQ, OQ, PQ) model for qualification that is also established as the general USP-chapter <1058>.The Warning Letters can be downloaded from the Labcompliance Usersclub. Scroll down to W-288. Non members can preview excerpts. To learn everything about FDA's and USP's expectation for qualification of instruments, attend the new Labcompliance audio seminar "Laboratory Equipment Calibration and Qualification according to USP <1058>", and receive a full set of qualification examples for trouble-free implementation.

Health Canada releases new GMP Guidelines for APIs

These Good Manufacturing Practices for Active Pharmaceutical Ingredients are designed to facilitate compliance by the regulated industry and to enhance consistency in the application of the regulatory requirements. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess. The focus of these guidelines is on the manufacture of APIs sold in their final labeled container and/or used in the manufacture of finished dosage forms for human use. More specifically, they apply to the fabrication, packaging/labeling, testing, importation, distribution, wholesale, and re-packaging/re-labeling of APIs (including their intermediates).. The guide is available for download on the Health Canada website.

Cooperation between US FDA and Indian Ministry of Health & Family Welfare for better Drug Safety

During Feb. 10-18 FDA's Commissioner Margaret Hamburg visited India to further strengthen cooperation between the FDA and its Indian regulatory counterparts. During the visit is has been agreed that the FDA and Indian Ministry of Health & Family Welfare will begin sharing information from quality inspections of drug and API manufacturing facilities. It also was agreed that the FDA would be working more closely with its Indian counterparts through holding seminars, webinars, meetings and training sessions to ensure that Indian drug exporters meet American standards. Such trainings are important when looking at the many warning letters the FDA did send to companies from India. For more details look at the new from New York Times from Feb 18. Labcompliance has conducted many seminars in India mainly in the area laboratory controls and records integrity. Attendees learned through presentations, interactive discussions and workshops how to prepare quality control laboratories and contract laboratories for upcoming FDA inspections, but obviously more companies need such training. For an example of successful seminar click here.

FDA releases a New Draft Guidance on "Validation of Bioanalytical Methods"

Once final the new guidance will replace the 2001 version. It applies to validation of bioanalytical methods used for analysis of blood, urine, and other biological samples in bioequivalency and bioavailability studies and in non-clinical pharmacology and toxicology studies. The new guidance is significantly different from the 2001 version, just a few examples: Opposite to the earlier guidance the new one includes requirements for System Suitability Testing.and for Incurred Sample Re-analysis and it has more details on the Ligand Binding Assays methodology, especially on acceptance criteria. Very useful is the section on documentation with many new requirements, for example sample analysis reporting should not only include all accepted but also all rejected analytical runs. The guidance is available for viewing and download from the FDA website. To learn everything about existing and new FDA requirements for validation of biological methods, attend the new Labcompliance seminar "Understanding the 'New' FDA Guide for Validation of Bioanalytical Methods".

New Part 11 Compliance Package for effective Training and Trouble-free Implementation

Labcompliance is introducing Version 3.1 of its popular Part 11 Compliance Package . The content has been updated with 20+ new or updated good practice guides, e.g., master plan, implementation guide, SOPs. checklists, examples and forms. The new package is ideally suited to prepare companies for the ongoing FDA Part 11 inspections with focus on security, integrity and availability of e-records. For example, SOPs are available addressing security and integrity and checklists, the step-by-step implementation plan and the Part 11 compliance master plan  have been updated accordingly.   For details on content and ordering, 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 Best Practice Document "SOP: Change Control of Analytical Equipment". To download your free copy, go to the Laboratory Equipment Calibration and Qualification website. Scroll down and click on the corresponding ICON on the left (offer expires on February 28 , 2014). 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.

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
    Recorded, available at any time
  2. Laboratory Equipment Calibration and Qualification according to USP <1058>
    With SOPs, Templates and Examples for easy Implementation
    Recorded, available at any time
  3. Understanding the New EU-GMP Annex 15 on Validation and Qualification
    New requirements and strategies for implementation
    April 3, 2014
  4. Understanding Quality by Design for the Pharmaceutical Industry
    Introduction to Principles, Regulatory Activities and Industry Practices
    April 17, 2014
  5. Validation of Analytical Methods according to the New FDA Guidance
    Understanding FDA's New Lifecycle Approach Towards Method Validation
    April 24, 2014
  6. Impact of Quality by Design on the Analytical Laboratory
    Learn through examples on development and validation of analytical procedures
    May 15, 2015

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.