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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

 

Effective Validation of Analytical Methods for GLP and Clinical Studies

Learn how to design, prepare, conduct and document for FDA Compliance

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

 

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 with all reference material at any time

 

Recent Regulatory Updates in Pharma and Biopharma Compliance

Get a comprehensive update in just one hour

Available on demand at any time with all reference material

 

Comparing GLP with GMP

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

Available on demand at any time with all reference material

 

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.

 

 

 

Korea and Japan to Join PIC/S

The PIC/S Committee has invited Japan and Korea to join PIC/S as of 1st July 2014. Japan will become the 45th PIC/S Participating Authority and will be represented by the Pharmaceutical & Food Safety Bureau of the Ministry of Health, Labour & Welfare (MHLW), the Pharmaceutical and Medical Devices Agency (PMDA) and the GMP Inspectorates of Japan's Prefectures. Korea's Ministry of Food and Drug Safety (MFDS) will become the 46th PIC/S Participating Authority. Both Japan and Korea applied for PIC/S membership on 9 March 2012 and 10 April 2012, respectively. Reference: PIC/S website.

New SOP and Checklist for Auditing QC Labs in Line with FDA Inspections

Auditing quality control laboratories is necessary to verify compliance of laboratory practices with regulations, with external and internal quality standards and with internal procedures. When done right, for example, with appropriate feedback and follow-up, audits can also help to improve the quality and efficiency of laboratory operations. To ensure compliance with FDA and equivalent international regulations audits should follow an SOP that defines responsibilities, steps and necessary documentation. Checklists further improve consistency and efficiency of audits. Labcompliance offers a new SOP and a checklist with the title:  "Auditing Quality Control Laboratories".  For ordering the SOP, click here and scroll down to S-511-03, for the checklist click here and scroll down to E-184-03. Both the SOP and Checklist are included in the handout of the new audio seminar: Auditing Quality Control Laboratories for FDA Compliance.

FDA launches "openFDA" to provide easy Access to valuable FDA public Data

In alignment with the recent Presidential Executive Order on Open Data and the Department of Health and Human Services Health Data Initiative, openFDA will make the FDA’s publicly available data accessible in a structured, computer readable format that will make it possible for technology specialists, such as mobile application creators, web developers, data visualization artists and researchers to quickly search, query, or pull massive amounts of public information instantaneously and directly from FDA datasets on an as needed basis. In addition to providing datasets, openFDA will encourage the innovative use of the agency’s publicly available data by highlighting potential data applications and providing, a place for community interaction with each other and with FDA domain experts. More information is available on the FDA website.

Inadequate Handling of OOS Test Results and Incomplete Records key Points of an FDA Warning Letter

The warning letter from June 16 this year was related to an inspection of a global API manufacturer earlier this year. As main issue about inadequate handling of OOS tests results FDA cited "product sample retesting without investigation and and rewriting and/or omission of original CGMP records persisted without implementation of controls to prevent data manipulation". FDA also found that "Raw data and sample preparation information used for the calculation of the test results that were found OOS or disregarded were not in fact available for review." Further more the letter stated: "Failure to record activities at the time they are performed" and "Failure to include adequate documentation during complaint investigation". The Warning Letters can be downloaded from the Labcompliance Usersclub. Scroll down to W-290. Non members can preview excerpts. To learn everything about FDA compliant handling of OOS test results and laboratory failure investigations, attend the new audio seminar related to OOS Situations and Failure Investigations .

EMA Publishes New Guidance Template for Qualified Person's

The objective of this guidance and the Qualified Person (QP) declaration template is to emphasize the importance of providing a valid declaration, to harmonize the format for the declaration, to forestall questions during assessment, and to enhance the efficiency of the regulatory process, including the timely processing of relevant regulatory submissions. Applicants are therefore strongly recommended to use the template to facilitate the validation of regulatory submissions and their review. The template can be downloaded from the EMA website.

FDA publishes final Guidance on Stability Testing for Generics

The U.S. FDA has released a final guidance on stability testing of drug substances and products with regard to generics. The guidance provides answers to more than 30 questions from the public comments the FDA received on the draft guidance for industry on ANDAs: Stability Testing of Drug Substances and Products. The guidance discusses general issues; drug master files (DMFs); drug product manufacturing and packaging; and stability studies. Questions include but are not limited to: What is the scope of and implementation date for the FDA stability guidance? Can an ANDA be submitted with 6 months of accelerated stability and 6 months of long-term stability data? When do intermediate stability studies need to be initiated in the event of failure at accelerated condition? When a patent is due to shortly expire and there are no approved ANDAs, can we file with 3 months stability data with a commitment to supply 6 months data when available?

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 "Handling Security Patches". To download your free copy, go to the Network Quality Package website. Scroll down and click on the corresponding ICON on the left (offer expires on July 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. Auditing QC Laboratories for FDA Compliance
    Learn how to use internal audits in preparation for regulatory inspections
    Recorded, available with all reference material at any time
  2. Effective Validation of Analytical Methods for GLP and Clinical Studies
    Learn how to design, prepare, conduct and document for FDA Compliance
    Recorded, available with all reference material at any time
  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
  4. Validation and Control of Excel Spreadsheets for FDA Compliance
    Understand requirements and get tool kits for easy implementation
    Recorded, available with all reference material at any time
  5. Comparing GLP with GMP
    Learn about similarities and differences and when to apply one or the other
    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.