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56 Usersclub Additions

- 15 SOPs
- 10 Examples/Checklists
- 3 Forms/Templates
- 7 FDA Presentations
- 21 Warning Letters

 

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

 

Elemental Impurities According to the new ICH Q3D and USP 232/233 Guidelines

With updates on selected elements, limits, analytical procedures and schedule.

Recorded, available at any time

 

GMP Compliance for Quality Control and Contract Laboratories

Up-to-date FDA/EMA Requirements and Tools for Cost Effective Implementation

November 21, 2013

 

Are You ready for FDA's 'New' Inspection and Enforcement Practices?

With Industry Proven Tool Kits for Preparation, Conduct and Follow-up

December 5, 2013 

 

Understanding FDA's New Guide on Using Computerized Systems in Clinical Investigations
With tool kit for cost effective implementation
January 23, 2014

 

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

 

FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control

With Strategies and best Practice Guides for easy Implementation

 Recorded, available at any time

 

System Suitability Testing for FDA and USP Compliance

Setting parameters and limits for chromatographic and other methods

Recorded, available at any time

 

Analytical Equipment Qualification and System Validation for FDA Compliance

Combining the USP <1058> with the new GAMP(TM) Laboratory Computer Systems Guide

Recorded, available at any time

 

Managing Electronic Raw Data in Regulated Environments

Definition, generation, evaluation and archiving for FDA, ICH, PIC/S and EU compliance

Recorded, available at any time

 

FDA Compliant Use of (Certified) Reference Material

Strategies for selection, purchasing, testing and documentation

Recorded, available at any time

 

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

 

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

 

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

 

Validation of Bioanalytical Methods and Procedures

Conduct and Document for Efficiency and FDA&EMA Compliance

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

 

with 10+ validation  examples, seminar with FDA's Dennis Cantellops and Ludwig Huber and with 13 SOPs for easy implementation.

 

 

 

 

FDA Publishes a New Draft Guidance on Bioanalytical Method Validation

Originally issued in 2001, this guidance has been revised to reflect advances in science and technology related to validating bioanalytical methods. It provides assistance to sponsors of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologic license
applications (BLAs), and supplements in developing bioanalytical method validation information used in human clinical pharmacology, bioavailability (BA), and bioequivalence (BE) studies that require pharmacokinetic (PK) or biomarker concentration evaluation. The draft guidance is available for viewing and download from the FDA website.

Multiple Laboratory GMP Violations cited in FDA Warning Letter

 During a recent inspection of a drug manufacturer  FDA investigators found significant deviations from current good manufacturing practice (cGMP) requirements in quality control of a licensed biological product. Deviations observed during the inspections included, but were not limited to the following: Inadequate stability testing, not following internal procedures, inadequate failure investigations, no root case analysis, ineffective CAPA, insufficient control of incoming material, SOPs for product testing not followed, inadequate handling of OOS results, no preventive equipment maintenance and inadequate risk assessment, The Warning Letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-285.  Learn all about FDA  current GMP requirements related to quality control laboratories and how to avoid Warning Letters in the new Labcompliance audio seminar

FDA releases a Draft Guidance on Requirements for ANDA Submissions

The Food and Drug Administration (FDA) has announced the availability of a draft guidance for industry entitled “ANDA Submissions—Refuse-to-Receive Standards.” This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and related submissions (i.e., prior approval supplements (PASs) for new strengths). The guidance contains details on what should be included in these submissions and highlights serious deficiencies that may cause FDA to refuse to receive the submission. The draft guidance is available for viewing and download from the FDA website.

USP Proposes a Revision Plan for General Chapters on Elemental Impurities

USP's Elemental Impurities Expert Panel reviewed the Step 2 limits of the ICH Q3D Elemental Impurities Working Group, which were released in June 2013. In addition to minor editorial changes the Panel recommended revisions to General Chapter <232> "Elemental Impurities - Limits" to partially align with the ICH Q3D limits. The Recommendations of the Expert Panel have been endorsed by the USP General Chapters—Chemical Analysis Expert Committee. According to the plan the proposed revisions will be pre-published in January 2014 on the USP Elemental Impurities Key Issues web page. The approved revised General Chapters will be published in the USP 38-NF 33 First Supplement in February 2015 and become official August 1, 2015. For details on similarities and differences between USP <232> and ICH Q3D attend the new Labcompliance audio seminar 'Elemental Impurities According to the new ICH Q3D and USP 232/233 Guidelines'

FDA releases the final Guidance on Use of Electronic Source Data in Clinical Investigations

An earlier version had been released as draft in November 2012. The final guidance  provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations. In an effort to streamline and modernize clinical investigations the guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission. According to the guidance FDA expects that capturing source data electronically should eliminate or reduce duplication of data, reduce transcription errors, encourage entering source data during a subject’s visit, facilitate remote monitoring of data, promote real-time access for data review and facilitate the collection of accurate and complete data and facilitate the collection of accurate and complete data. The guidance is available for viewing and download on the FDA website. To learn everything about the guidance attend the new Labcompliance audio seminar "FDA's New Guide on Use of Electronic Source Data in Clinical Investigations" and receive 10+ Best Practice Guides for 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 "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 November 15 , 2013). Labcompliance offers more than 150 SOPs that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here.

Audio Seminar Schedule

  1. Quality by Design (QbD) for Development and Validation of Analytical Methods
    Apply modern Lifecycle Management Principles for Analytical Methods
    October 31, 2013
  2. GMP Compliance for Quality Control and Contract Laboratories
    Up-to-date FDA/EMA Requirements and Tools for Cost Effective Implementation
    November 21, 2013
  3. Are You ready for FDA's 'New' Inspection and Enforcement Practices?
    With Industry Proven Tool Kits for Preparation, Conduct and Follow-up
    December 5, 2013
  4. FDA's New Guide on Use of Electronic Source Data in Clinical Investigations
    With tool kit for cost effective implementation
    January 23, 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.