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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

 

New OECD Guide: Using Computer Systems in GLP Studies

Understanding and Implementing the new OECD Guide for Computer Systems November 6, 2014

 

Review of Analytical Methods as Alternative to regular Revalidation

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

September 30, 2014

 

Managing Out of Trend Results in Pharmaceutical Quality Control

With Strategies and best Practice Guides for easy Implementation

October 28, 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

 

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.

 

 

 

FDA publishes Purple Book with Lists of Licensed Biological Products

The “Purple Book” lists biological products, including any biosimilar and interchangeable biological products, licensed by FDA under the Public Health Service Act (the PHS Act). The lists include the date a biological product was licensed under 351(a) of the PHS Act and whether FDA evaluated the biological product for reference product exclusivity under section 351(k)(7) of the PHS Act. The Purple Book will also enable a user to see whether a biological product licensed under section 351(k) of the PHS Act has been determined by FDA to be biosimilar to or interchangeable with a reference biological product.

Regular Revalidation or Review of Analytical Methods: Evaluation of Efficiency and Costs   

The suitability of analytical methods used in FDA and equivalent international requirements  should be demonstrated under actual conditions of use. For methods developed in house this means methods should be  initially validated and the suitability of compendial methods and methods transferred  from other labs should be verified following USP <1226> and <1224>. The suitability of the lab should not only be demonstrated when used the first time in the lab about also during routine use. The standard procedure for this is regular revalidation or re-verification. This is time consuming and frequently not very efficient compared to a method review. Recent official guidance documents also support the method review as a more cost effective way to answer the inspector's primary question: How do you know that the method remains in a validated state? The current issue is that there is no practical information available on how to perform such a review.  Attend the new Labcompliance audio seminar to learn everything about such a review and receive and SOP with a checklist for easy implementation.

The ICH M7 Guideline on DNA Reactive Impurities enters the Implementation Period (Step 5)

The purpose of this new ICH Guideline is to offer guidance on analysis of structure activity relationships (SAR) for genotoxicity. Furthermore, it is intended to resolve questions such as whether impurities with similar alerts that potentially have similar mechanism of action should not be combined in calculating a Threshold of Toxicological Concern (TTC) and whether the TTC may differ based on differences in the approved duration of use. The ICH guideline has also been recommended for adoption by EU, Japanese and U.S. regulatory authorities.

How to Qualify Trainers in FDA regulated Areas?

While  there is a good understanding on how to document trainings for trainees this is not the case for trainers. In general, trainers should have "qualified" which means they not only should have the content expertise but also know how to present the information. FDA GMP does not specifically spell out requirements for trainers but advice can be taken from  Sec. 211.34 on requirements for consultants. "Consultants advising on the manufacture, processing, packing, or holding of drug products shall have sufficient education, training, and experience, or any combination thereof, to advise on the subject for which they are retained. Records shall be maintained stating the name, address, and qualifications of any consultants and the type of service they provide". Following this trainers should provide a document listing name, address, qualifications and the type of trainings they provide.  For an example, see qualifications  of Ludwig Huber.

FDA releases two new Guidance Documents for ANDA Submission

On Sept 17 FDA published notices in the Federal Register announcing the availability of one final and one draft guidance for industry. The final guidance entitled: "ANDA Submissions - Refuse-to-Receive Standards" assists applicants preparing to submit abbreviated new drug applications (ANDAs), and related submissions (i.e., prior approval supplements (PASs) for new strengths).
The draft guidance entitled "ANDA Submissions - Refuse-to-Receive for Lack of Proper Justification of Impurity Limits" assists applicants preparing to submit to FDA ANDAs, for which the applicant is seeking approval of a new strength of the drug product. It highlights deficiencies in information about impurities that may cause FDA to refuse-to-receive an ANDA or new strength PAS.

MHRA publishes Guidance for Development of Software used as Medical Device

This new guidance published by the British Medicines and Healthcare Products Regulatory Agency (MHRA) explains how this software development is regulated. It covers stand-alone software (also known as software as a medical device) but not software that is part of an existing medical device because this seen to be part of the device, e.g. software that controls a CT scanner. The guidance can be downloaded from the MHRA website.

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 "Computer System Validation Master Plan". To download your free copy, go to the Computer System Validation Package website. Scroll down and click on the corresponding ICON on the left (offer expires on September 30 , 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. New OECD Guide: Using Computer Systems in GLP Studies
    Understanding and Implementing the new OECD Guide for Computer Systems 
    November 6, 2014
  2. Managing Out of Trend Results in Pharmaceutical Quality Control
    With Case Studies on how to Avoid and Respond to Recent 483s/Warning Letters
    October 28, 2014

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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.