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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

 

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-PIC/S 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 December 2012

New FDA Guidance: Electronic Source Data in Clinical Investigations

In an effort to streamline and modernize clinical investigations, this draft guidance provides recommendations to sponsors, Contract Research Organizations (CROs), data management centers, clinical investigators, and others involved in capturing, reviewing, and archiving electronic source data in FDA-regulated clinical investigations. This guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of electronic source data. The guidance is intended to be used together with the FDA guidance for industry on Computerized Systems Used in Clinical Investigations, and with the FDA regulations on Electronic Records and Electronic Signatures (21 CFR part 11). The guidance can be downloaded from the FDA Website.

EU/PICS GMP Annex 11: The new global Standard for Computer Management and Validation

Since the EU GMP Annex 11 has been adopted by PIC/S the Annex is on its best way to become the golden regulatory standard worldwide, not only for validation of computerized systems but for the entire management. With 43 members including US FDA, all EU member countries, Asian countries such as Singapore and Indonesia and others such as Korea and Japan that have applied to become a member, PIC/S is the largest regulatory organization. And Annex 11 addresses all computer and data management requirements, including validation. Most of them are also required by Part 11 and the related guidance document, but also through FDA inspection and enforcement practices. An example is "Review of electronic Audi Trail". In a new Labcompliance seminar we go through all requirements and give practical recommendations on how to implement them from the view of FDA and European inspectors. .

How to Qualify Manufacturers of APIs: Questions and Answers

There is a clear global trend to better control  manufacturers of APIs, for example through inspections by agencies and through audits by pharmaceutical manufacturers and 3rd parties. Both manufacturers of APIs and clients are unsure what the exact regulatory requirements are and any published statements are welcome. In light of this the Danish  Health and Medicines Agency might help: The site has a Q&A section related to GMP requirements for manufacturers of active pharmaceutical ingredients (APIs) . Examples of questions are: Who are considered manufacturers of active pharmaceutical ingredients? What documentation is required to substantiate that the active pharmaceutical ingredient has been manufactured in accordance with GMP? Where does the pharmaceutical manufacturer document that active pharmaceutical ingredients have been manufactured in compliance with GMP? What are the consequences if an API manufacturer has not been audited? Even though answers are provided by a single agency. The spirit of the answers may be applicable for most others

FDA understands the Industry's  Need for Virtual Networks and Cloud Computing

This became obvious in a presentation by B. Fitzgerald, Deputy Director, CDRH, FDA. The title of the presentation was: Virtualization and Cloud Computing, Presented at the Workshop, FDA Blood establishment computer software, Maryland , USA. Here is a quote from the presenter: "With the advent of commodity server farms and with the need for reducing costs, it is more and more imperative for industry to begin to outsource the hosting of their applications - their in-house applications, their enterprise automation". And FDA also does it, just look at the next quote: "There will always be a tendency to want to outsource this to a large server farm. We actually in FDA did that. We have outsourced our server farm from FDA's campus to a facility in Northern Virginia, completely virtualized on someone else's servers". Despite of these promising statements, there are still FDA regulations the industry has to comply with: GLP, GCP, GMP and 21 CFT Part 11. The industry still has to demonstrate accuracy, integrity, availability, security and confidentiality of data.  Attend the new Labcompliance Audio seminar on how to comply with FDA's regulations when using cloud computing. 

New ICH/FDA Guidance on Genotoxicity Testing for Pharmaceuticals

The document with the title "Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use" has been published as S2(R1) by ICH and US FDA. It replaces two ICH guidances, S2A, "Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals" and S2B Genotoxicity: "A Standard Battery for Genotoxicity Testing of Pharmaceuticals". The purpose of the revision is to provide guidance on optimizing the standard genetic toxicology battery for prediction of potential human risks, and on interpreting results, with the goal of improving risk characterization for carcinogenic effects that have their basis in changes in genetic material. The revised guidance describes internationally agreed-upon standards for follow-up testing and interpretation of positive results in vitro and in vivo in the standard genetic toxicology battery, including assessment of non-relevant findings. The guidance is available for viewing and  download from the FDA Website

How to Qualify IT Infrastructure?

FDA and international agencies require computers systems to be validated and the underlying network infrastructure to be qualified. For example, Annex 11 to EU-PIC/S GMP states: "The application should be validated; IT infrastructure should be qualified" While the validation of software applications is well understood this is not the case for qualification of networks and infrastructure. IT infrastructure qualification includes 4 steps: 1) Make a plan 2) Design and specify the network 3) Install the network, document all details including system drawings, and verify correct installation   4)  Keep all network components components under strict change configuration management and change control. For details of regulatory requirements and how to implement four steps, attend the Labcompliance audio seminar "FDA Compliant IT Infrastructure and Network Qualification"

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 "Electronic Audit Trail: Specifications, Implementation and Validation". To download your free copy, go to the Part 11 Compliance Package website. Scroll down and click on the corresponding ICON on the left (offer expires on December 31, 2012). Labcompliance offers more than 120 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. Understanding and Implementing the New EU-PIC/S Annex 11
    Prepare Yourself for the upcoming Inspections and Enforcement
    December 20, 2012
  2. FDA Compliant IT Infrastructure and Network Qualification
    With Strategies and Tool Kit for Compliance and System Uptime
    January 10, 2013
  3. 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
  4. Efficient Training Practices for FDA and International Compliance
    Learn what to train - How much to Train - How to Document Effectiveness
    February 7, 2013

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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.