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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

 

Selecting Acceptance Criteria for Regulatory Method Validation

Learn through case studies and get inspection ready documentation

July 10, 2012

 

Qualification and Use of Virtual Networks in Regulated Environments

With Strategies and Tool Kit for Compliance and System Uptime

July 12, 2012

 

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

July 26, 2012

 

Verification of Compendial Methods according to the New 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

 

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

 

Analytical Instrument Qualification According to USP <1058>

With SOPs, Templates and Examples for Easy Implementation

Recorded

 

 

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

 

 

Labcompliance News June 2012

Indonesia Joins PIC/S

The Committee invited the Indonesian National Agency of Drug and Food Control (NADFC) to join the Scheme as from 1 July 2012. NADFC will become PIC/S’ 41st Participating Authority. NADFC applied for membership back in April 2008. The first on-site assessment took place in November 2010 followed by a second visit in particular with respect to traditional herbal medicines issues in December 2011. Further to this visit, actions and corrective measures were undertaken by NADFC which led the PIC/S Audit team to recommend to the Committee to accept the membership application of NADFC. (Reference PIC/S Press Release).

Labcompliance releases new New Computer System Validation Package

On May 1 Labcompliance has released a new major revision of the popular Computer System Validation package. The new version includes 7 new SOPs, an updated CSV Master Plan, an updated step-by-step implementation plan, a an updated primer and two new audio seminars. In addition most other key documents have been updated to reflect most recent recommendations from official regulatory and industry committees. We also have added SOPs and examples for new topics such as cloud computing and handling deviations during testing. With the new additions the package includes 38 SOPs, 11 checklists, 23 validation examples and  15 forms for all aspects of computer system validation.  For additional information and ordering, click here.

FDA Presentation on International Compliance Issues

The topic has been presented by Carmelo Rosa from the FDA Office of Compliance. Mr. Rosa talked about  globalization issues and how FDA responds through collaboration initiatives. Most interesting was the part about the current inspections process and enforcement strategy. The presentation includes more than 10 slides with recent FDA warning letter statements. About 70 % are related to testing in  quality laboratories. The Presentation is available for members of the Labcompliance Usersclub.

Free E-Book on Virtualization of Computer Systems and Networks

Virtualization of computers and networks can be quite attractive for organizations to reduce overall costs. For everybody who want to learn about these technology and benefits we recommend the 212-page e-book that as of June 2012 can be be ordered at no charge through the Web. The title is: "The Definitive Guide to Virtual Platform Management"  After studying the book one  question still remains: What does it mean for the FDA and other regulated industries?  Does the FDA and other agencies allow the use of virtual networks and if so; what about qualification? Attend the Labcompliance seminar "Qualification of Virtual Networks " to get a good overview on issues and solutions and get 10+ good practice guides for implementation.

EMA Releases Draft Guideline on Similar Biological Medicinal Products

The draft with the exact title: "Similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues" has been released for consultation. The guideline lays down the quality requirements for a biological medicinal product claiming to be similar to another one already marketed. It addresses the requirements regarding manufacturing processes, the comparability exercise for quality, considering the choice of reference medicinal product, analytical methods, physicochemical characterization, biological activity, purity and quality attributes for relevant specifications of the similar biological medicinal product. The draft is available on the EMA website.

Korea applies for PIC/S membership

On 10 April 2012, the Korea Food and Drug Administration (KFDA) applied for PIC/S membership. The Rapporteurs have been appointed at the PIC/S Committee Meeting on 7-8 May 2012 in Geneva, Reference: PIC/S News. With this new addition currently there are five Asian agencies on the PIC/S application list: Japan, Philippines, Indonesia, Thailand and Korea.

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: Measurement Uncertainty in Chemical Testing". To download your free copy, go to the ISO 17025 Accreditation Package website.. Scroll down and click on the corresponding ICON on the left (offer expires on July 12). Labcompliance offers more than 130 SOPs and other documents that help to comply with FDA and ISO 17025 compliance. For titles and ordering, click here

Audio Seminar Schedule

 

  1. Selecting Acceptance Criteria for Regulatory Method Validation
    Learn through case studies and get inspection ready documentation
    July 10, 2012
  2. Qualification and Use of Virtual Networks in Regulated Environments
    With Strategies and Tool Kit for Compliance and System Uptime
    July 12, 2012
  3. Implementing the New USP Chapters 232/233 for Elemental Impurities
    Learn how to comply with FDA, USP and ICH Requirements
    July 26, 2012

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