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


 

50 New Usersclub Additions

- 18 SOPs
- 12 Examples/Checklists
- 5 Forms/Templates
- 2 Master Plans/Primers
- 3 FDA Presentations
- 10 Warning Letters

 

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

 

Cost Effective Validation of Laboratory Computer Systems

With industry proven examples for all validation steps

Recorded, available at any time

 

Using Electronic and Digital Signatures in Regulated Environments

Comply with FDA Part 11 and with international regulations and guidelines

Recorded
Available at any time

 

Validation of Analytical Methods for GLP and Clinical Studies

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

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

December 13, 2012

 

Understanding and Implementing the New EU Annex 11

Prepare Yourself for the upcoming Inspections and Enforcement

December 20, 2012

 

Calibration and

Calibration and Qualification of Stability Chambers

With 10 examples/templates for all validation steps

Recorded

 

FDA Compliant Use of (Certified) Reference Material

Strategies for selection, purchasing, testing and documentation

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

 

Verification of Compendial Methods according to the Revised USP Chapter <1226>

Understand the new risk based approach and get real world case studies for testing

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

 

Validation and Use of Excel® Spreadsheets in Regulated Environments

Comply with Part 11, QSR, and Annex 11.

Recorded
Available at any time

 

Implementing the New USP Chapters 232/233 for Elemental Impurities

Learn how to comply with FDA, USP and ICH Requirements

Recorded, available at any time

 

Verification of Compendial Methods according to the Revised USP Chapter <1226>

Understand the new risk based approach and get real world case studies for testing

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

 

Validation of Bioanalytical Methods and Procedures

Conduct and Document for Efficiency and FDA&EMA Compliance

Recorded, available at any time

 

Raw Data in FDA Regulated Environments

FDA/EU compliant recording, maintenance and archiving

Recorded, available at any time

 

Learning from Recent Warning Letters Related to GMP Laboratory Controls

For Preparation of FDA and International GMP Laboratory Inspections

Recorded, available at any time

 

Development and Validation of Stability Indicating Methods for FDA/ICH Compliance

Sample generation - method development - validation - documentation

Recorded, available at any time

 

FDA Compliant Use of (Certified) Reference Material

With 10+ Best Practices for easy Implementation

Recorded, available at any time

 

Analytical Instrument Qualification According to USP <1058>

With SOPs, Templates and Examples for Easy Implementation

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.

 

 

 

 

Labcompliance News November 2012

FDA publishes ICH Guidance on Development and Manufacture of Drug Substances

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled “Q11 Development and Manufacture of Drug Substances.” The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes approaches to developing and understanding the manufacturing process of a drug substance and provides guidance on what information should be provided in certain sections of the Common Technical Document (CTD). The Guidance can be viewed and downloaded from the FDA website.

USP Postpones the official Date for Chapters <232/233>

The Executive Committee of the Council of Experts has postponed the official dates of <232> Elemental Impurities—Limits and <233> Elemental Impurities—Methods. The purpose for the postponement is to allow adequate time for the Executive Committee of the Council of Experts to adjudicate and render a decision on three appeals related to the two general chapters. For the press release, click here. USP did not announce a new official date. Even though the release  date for the chapters has been postponed, the date for obsolescence of USP <231> did not change. This is April 2014. Companies are still advised to to prepare themselves and start implementing the new chapters and ICH Q3D.  Attend the Labcompliance audio seminar to learn everything about elemental impurities according to USP chapters and ICH Q3D and receive 10 best practice guides for easy implementation.

Three easy steps towards FDA compliant Electronic Signatures

FDA Part 11 and other regulations such EU GMP Annex 11 allow to sign electronic records with electronic and digital signatures. Benefits for regulated user firms are improved accuracy through reduced transcription errors, higher overall efficiency through automated  processes and reduced costs for handling and storing paper records. While all companies use electronic records electronic signatures are not widely used in regulated areas. Companies are just not sure about specific requirements and frequently IT professionals are not familiar with regulations. However with the right guidance setting up an electronic signature system is easy, it just requires three  steps: 1) Developing procedures, 2) Specifying software requirements and purchasing or upgrading a system and 3) Implementing the system and procedures as defined in 1) and 2).  The new Labcompliance audio seminar not only provides detailed guidance for the entire process but also includes SOPs and examples for easy implementation..

New Zealand and Taiwan to Join PIC/S

The Committee invited the New Zealand’s Medicines and Medical Devices Safety Authority and Chinese Taipei / Taiwan Food and Drug Administration (TFDA) to join40F00216 PIC/S as from 1 January 2013.  Uganda and Belarus received pre-accession membership. Korea, Japan, Brazil, Iran and Philippines have submitted applications. China's SFDA indicated that accession to PIC/S is a priority. (Reference PIC/S Press Release).

Biosimilars Handbook available from the European Generic Medicines Association

This handbook aims to provide updated information on the current progress of biosimilar medicines in the European Union (EU). The first edition of this short guide to biosimilar medicines was published in 2007. At the time of first publication, only 5 biosimilar medicines had been approved in Europe, and both the legislation and concepts for these products were very new. Now the situation has developed and changed, as will be described herein, and the clinical and health economic benefits offered by biosimilar medicines to patients, clinicians and healthcare providers are considerably clearer. or more information and ordering, click here.

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 Labcompliace 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

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 "Revalidation of Software and Computer Systems". To download your free copy, go to the Macro and Spreadsheet Quality Package website. Scroll down and click on the corresponding ICON on the left (offer expires on December 15, 2012). Labcompliance offers more than 130 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

IVT’s 3rd´Validation Week Singapore

The Pan Pacific’s Most Comprehensive Event Dedicated to Validation
February 25-26, 2013
Pan Pacific Hotel, Singapore

With Dr. Ludwig Huber as keynote speaker

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
    December 13, 2012
  2. Understanding and Implementing the New EU Annex 11
    Prepare Yourself for the upcoming Inspections and Enforcement
    December 20, 2012
  3. FDA Compliant IT Infrastructure and Network Qualification
    With Strategies and Tool Kit for Compliance and System Uptime
    January 10, 2013
  4. Quality by Design (QbD) for Analytical Method Development and Validation
    Learn how to design robustness for easy transfer and to avoid OOS situations
    January 24, 2013
  5. Efficient Training Practices for FDA and International Compliance
    Learn what to train - How much to Train - How to Document Effectiveness
    February 7, 2013

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.