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

 

How to Effectively  Build a GLP Laboratory

Step-by-step from design to compliant and cost-effective implementation

Recorded, available at any time

 

Setting up a Quality System for Pharmaceutical Laboratories

Understanding and Implementing ICH Q10 and other Quality Systems

Recorded, available at any time

 

Transfer of Analytical Procedures According to the New USP Chapter <1224>

With SOPs, templates and examples for easy implementation

March 21, 2013

 

Quality by Design (QbD) for Analytical Method Development and Validation
Learn how to design robustness for easy transfer and to avoid OOS situations
Recorded, available at any time

 

Efficient Training Practices for FDA and International Compliance
Learn what to train - How much to Train - How to Document Effectiveness
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

 

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

 

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 January 2013

USP Chapters <232> and <233> for Elemental Impurities Final

USP is releasing the final chapters for elemental impurities on February 1. While chapter <232> defines elements and limits chapter <233> describes test equipment and procedures. The current chapter <231> is still active until April 2014 but according to an USP General Notices release will be obsolete by May 1, 2014. This means all monographs with requirements for heavy metal testing will have to follow the new USP chapters. Details about this process can be found on the USP website. To learn everything about requirements for elemental impurities attend the new audio seminar: "Elemental Impurities According to the Final USP Chapters 232/233" 

FDA Expects Periodic Requalification of GCs and HPLCs

This became obvious in a recent FDA inspection of a testing laboratory followed by a warning letter. The warning letter reads: Your firm has failed to calibrate instruments and recording devices at suitable intervals in accordance with an established written program containing specific directions, schedules, limits for accuracy and precision, and provisions for remedial action in the event accuracy and/or precision limits are not met [21 C.F.R. § 211.160(b)(4)].For example,

  • Your firm does not have an established written program to calibrate/qualify the xxx gas chromatograph (GC) at suitable intervals.
  • Your firm did not calibrate and qualify the xxx high performance liquid chromatography (HPLC) instrumentation adequately, in that there is no periodic qualification or evaluation of the pump, oven, injector, or detector.

The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-278.  To learn everything how to qualify and re-qualify analytical equipment attend the audio seminar  "Laboratory Equipment Qualification according to USP <1058>" The seminar suggests extent and frequency of periodic requalification.

FDA Presentation on Quality by Design for Analytical Methods Available

The topic has been presented by Yubing Tang, PhD, from the FDA/CDER.  After an overview of QbD Dr Tang talked about the role of analytical methods under QbD approach and the benefits of QbD for the industry. Most interesting was the part on 'Regulatory considerations of the QbD approach for analytical methods'. In the concluding remarks Dr. Tang encouraged applicants to discuss ‘novel’ QbD implementation approaches with the agency prior to submission . The presentation  is available for members of the Labcompliance Usersclub and for attendees of the upcoming Labcompliance audio seminar "Quality by Design (QbD) for Development and Validation of Analytical Methods".

FDA Warning Letter for Insufficient  Training and inadequate Response

Inadequate training continues to be one of the top citations in FDA warning letters. This became obvious in a new warning letter from December 2012. In this example laboratory personnel did not follow procedures to comply with GMP requirements due to insufficient training. The letter reads: "Your firm failed to ensure that each person has the education, training, and experience, or any combination thereof, to enable that person to perform his or her assigned functions. Personnel were not following the procedures that govern their activities, such as glove change frequency, the handling of dropped objects, personnel monitoring, and sample acquisition." Even though the drug manufacturer responded that the personnel has been retrained, the response was not acceptable because no root cause analysis has been made to find out why the original training was not successful: "Your response did not provide an explanation for why your (training) system was unable to recognize, identify and mitigate these performance lapses".  The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts. Scroll down to W-279.  To learn how to conduct, verify effectiveness and document trainings  attend the audio seminar  "Effective Training Practices for FDA and International Compliance". The training reference material includes several examples of training related FDA warning letters, root cause analyses and corrective and preventive action plans.  

FDA Expects Multifold Increase of Foreign Generic Drug Manufacturer Inspections

New user fees through the Generic Drug User Fee Amendments (GDFUFA) as part of the new Food and Drug Administration Safety and Innovation Act will enable FDA to substantially increase the frequency of foreign inspections to every 2 years. Manufacturers of  biosimilar and generic drugs will be assessed an annual establishment fee equal to the establishment fees paid for proprietary drug product establishments.  Currently, FDA only has resources to conduct inspections of foreign generic drug manufacturers  once every 7 to 13 years. For more information read the related FDA fact sheet. To learn everything about FDA's new inspection and enforcement practices register for the Labcompliance audio seminar,

NATA Updates Technical Note for the Validation of Test Methods

Method validation and verification are essential requirements of accreditation to ISO/IEC 17025 and ISO 15189. Accordingly, facilities accredited to these Standards must demonstrate the validity of all methods used by validating all in-house and modified standard methods and verifying standard methods. This 33-page Technical Note published by the Australian National Association of Testing Authorities (NATA) describes the aspects of a method that should be considered when undertaking method validation or method verification, and provides guidance on how they may be investigated and evaluated. The guidance is available for free from the NATA 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 Best Practice Document "SOP: Handling Out-of-Specification Results". To download your free copy, go to the Laboratory Compliance Package website. Scroll down and click on the corresponding ICON on the left (offer expires on February 10 , 2013). Labcompliance offers more than 150 SOPs and other documents 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. Efficient Training Practices for FDA and International Compliance
    Learn what to train - How much to Train - How to Document Effectiveness
    February 7, 2013
  2. How to Effectively Build a GLP Laboratory
    Step-by-step from design to compliant and cost-effective implementation
    February 14, 2013
  3. Setting up a Quality System for Pharmaceutical Laboratories
    Understanding and Implementing ICH Q10 and other Quality Systems
     March 7, 2013
  4. Transfer of Analytical Procedures According to the New USP Chapter <1224>
    With SOPs, templates and examples for easy implementation
    March 21, 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.