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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

 

Computer System Validation: Step-by-Step

With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation

September 4, 2014

 

Regular Review of Analytical Methods as Alternative to Revalidation

Understand how to remain in compliance at much lower costs and at higher effectiveness

October 4, 2014

 

Managing Out of Trend Results in Pharmaceutical Quality Control

With Strategies and best Practice Guides for easy Implementation

October 29, 2014 

 

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

With Clear Recommendations for Corrective and Preventive Actions

Recorded, available with all reference material at any time

 

Handling Out-of-Specification Tests Results and Failure Investigations

With Case Studies on how to Avoid and Respond to Recent 483s/Warning Letters

Recorded, available with all reference material at any time

 

Recent Regulatory Updates in Pharma and Biopharma Compliance

Get a comprehensive update in just one hour

Recorded, available at any time

 

Comparing GLP with GMP

Learn about similarities and differences and when to apply one or the other

Recorded, available at any time

 

Validation and Control of Excel Spreadsheets for FDA Compliance

Understand requirements and get tool kits for easy implementation

Recorded, available at any time

 

Auditing QC Laboratories for FDA Compliance

Learn how to use internal audits in preparation for regulatory inspections

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.

 

 

                           News - July 2014

Share Price of  API Manufacturer drop 13 % after FDA inspection with 483 form Observations

It is well known that FDA inspections with enforcement actions such as Warning Letters, shipment stop, import alert or consent decree can have a high impact on a company's share price. It is quite unusual that a 483 form inspectional observation can have similar consequences. However, exactly this happened with an Indian API manufacturer. As a result of the 483 the company made an announcement to voluntarily stop API shipments from the inspected  plant. Next day the company's share was down 13 %. For more information click here.

 

 FDA publishes Strategic Priorities 2014-2018 for Public Comment

This 40-page draft document provides an overarching Agency-level view of how FDA is addressing the public health challenges. The paper lists four major goals with detailed  3 or 4 objectives for each of them. The goals are 1)Enhance Oversight of FDA-Regulated Products, 2)Improve and Safeguard Access to FDA-Regulated Products to Benefit Health, 3)Promote Better Informed Decisions About the use of FDA-Regulated Products, 4)Strengthen Organizational Excellence and Accountability.  Objectives are in line with ongoing initiatives such as addressing the impact of globalization through collaboration with regulatory counterparts to leverage resources and avoid duplication of inspections as well as build a model for mutual reliance by sharing inspection reports. As another example the FDA is encouraging submission of new drug applications using Quality by Design (QbD) elements – a risk-based approach to pharmaceutical development and manufacturing to help ensure product quality. Furthermore FDA plans to Improve risk-based approaches to conducting inspections that maximize public health benefit by ensuring high rates of compliance. The document also includes a current high-level FDA org chart. The paper is available on the FDA website for download.

EU GMPs require Procedures for handling OOS and OOT Results

The European Commission published a new revision of the EU GMP Chapter 6 - Quality control. The final version of the revised Chapter 6 was published in late March 2014 and becomes effective Oct 1, 2014. One change in the update is related to handling out-of-specification situations. The new GMP not only requires a procedure for investigation of OOS results but also significant atypical Out-of-Trend results. So far the US FDA industry guidance for handling OOS results was used in preparation EMA inspections, it seems this is not enough any more. Manufacturers of drugs and drug substances are advised to study the new regulation and to prepare SOPs accordingly. Attend the new audio seminar on "Handling Out-of-Specification Tests Results" and receive example SOPs for managing OOS and OOT results.

Two Identical Audio Seminar Sessions targeted for different Time Zones

Future Labcompliance audio seminars will be presented twice for different time zones. This will allow all attendees to participate during normal working hours.
Timing will be

  • Session 1 for: Eastern and Central Europe, Middle East, Asia, Australia
    India: 12.30 p.m. Singapore SGT: 3 p.m,, Japan and South Korea 4 p.m.
    Eastern/Central Europe: 9 a.m. CET (Berlin)

  • Session 2 for  America, Western Europe
    North America: EDT 11 a.m.  CDT 10 a.m. PDT 8 a.m.,
    Western Europe: UK, Ireland 4 p.m. BST (London)

The first two seminars delivered for two time zones have been:  Handling Out-of-Specification Tests Results and Failure Investigations and Learning from recent Warning Letters related to Part 11 and Computer Validation

FDA extending Part 11 Inspections to outside Asia and finds many Violations

Based on bad experiences with data integrity and system security issues the FDA extended Part 11 inspections from India and China to other parts of the words. And they are found signification deviations during an inspection of an API manufacturer. For example, the firm did not retain complete raw data from testing performed to ensure the quality of  APIs. Specifically, the firm deleted all electronic raw data supporting  high performance liquid chromatography (HPLC) testing of all API products released to the U.S. market. Furthermore the firm failed to retain basic chromatographic information such as injection sequence, instrument method or integration method for the tests. In addition the API manufacturer failed to prevent unauthorized access or changes to data and to ensure that employees receive appropriate and documented training on the particular operations that the employee performs. The Warning Letter can be downloaded from the Labcompliance Usersclub. Scroll down to W-291. Non members can preview excerpts. Attend the new Labcompliance audio seminar "Learning from Recent Warning Letters Related to Computer Validation and Part 11" to learn all about recent Part 11 related findings and get clear recommendations for corrective and preventive actions

 

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 "Multinational GMP Inspections: Preparation, Conduct, Follow-up". To download your free copy, go to the FDA Inspection Package website. Scroll down and click on the corresponding ICON on the left (offer expires on August 15 , 2014). Labcompliance offers more than 150 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

  1. Computer System Validation: Step-by-Step
    With Case Studies and IQ, OQ, PQ Protocols for Easy Implementation
    September 4, 2014
  2. Regular Review of Analytical Methods as Alternative to Revalidation
    Understand how to remain in compliance at much lower costs and at higher effectiveness
    October 4, 2014
  3. Handling Out-of-Specification Tests Results and Failure Investigations
    With Case Studies on how to Avoid and Respond to Recent 483s/Warning Letters
    Recorded, available with all reference material at any time

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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.