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56 Usersclub Additions

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

 

2-day seminar

Computer System Validation and
Part 11 Compliance

by Dr. Ludwig Huber

June 05&06 2013
Istanbul, Turkey

 

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

 

FDA/EMA Compliance of Genotoxic Impurities

Understanding and Implementing the new ICH M7 and other Guidelines

May 14, 2013

 

Comparing GLP with GMP

Learn about similarities and differences and when to apply one or the other

May 7, 2013

 

How to Ensure Integrity of Laboratory Data

Comply with new FDA inspection practices and EU Annex 11 requirements

May 23, 20133

 

Regulatory Aspects of Biosimilar Biological Products

Understand and Implement recent FDA and updated EMA Guidances

June 13, 2013

 

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

With SOPs, templates and examples for easy implementation

Recorded, available at any time

 

Elemental Impurities According to the Final USP Chapters 232/233

With updates on the new ICH Q3D Guide: Elements, Limits and Schedule

Recorded, available at any time

 

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
February 7, 2013

 

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

 

FDA/EMA Requirements for Genotoxic Impurities

Understanding and Implementing the ICH M7 and other Guidelines

May 15, 2013

 

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 April 2013

FDA Releases Draft Guidance on Setting Limits for Mutagenic Impurities

Just about two months after the release of the equivalent ICH M7 guidance FDA adapted this document as official FDA Draft Guidance entitled "M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk". The draft guidance emphasizes considerations of both safety and quality risk management in establishing levels of mutagenic impurities that are expected to pose negligible carcinogenic risk. It outlines recommendations for assessment and control of mutagenic impurities that reside or are reasonably expected to reside in a final drug substance or product, taking into consideration the intended conditions of human use. The guidance can be viewed and downloaded from the FDA website. To learn everything about regulatory requirements and analysis of genotoxic/mutagenic/carcinogenic impurities in drug substances and drug products including requirements of ICH M7 attend the Labcompliance audio seminar: "FDA/EMA Compliance for Genotoxic Impurities" and receive 10+ best practice guides for easy implementation

FDA Releases Final Guidance for Computer System Validation

The title of the new guidance is "Blood Establishment Computer System Validation in the User’s Facility". The guidance seems to very specific for Blood Establishment Systems, however the recommendations are fully applicable for all Commercial Off-the-Shelf Computer Systems. It is the only such guide available for FDA regulated industry and readers can learn what FDA's expectations are for validating computer systems at the users site. The guidance can be viewed and downloaded from the FDA website.

Revised EU GMP Guide Requires formal Transfer of Analytical Methods

The requirements are documented in the revised Chapter 4 Quality Control of the EU GMP guide.  Section 6.37 reads: Prior to transferring a test method, the transferring site should verify that the test method(s) comply with those as described in the Marketing Authorization or the relevant technical dossier. The original validation of the test method(s) should be reviewed to ensure compliance with current ICH requirements. A gap analysis should be performed and documented to identify any supplementary validation that should be performed, prior to commencing the technical transfer process. Sections 6.38 and 6.39 describe the requirements and contents of a transfer protocol. Recommended procedures are similar to the final release of USP <1224>. To read and download revised draft, click here. To learn more about requirements and examples for analytical method transfer attend the Labcompliance seminar and received a tool kit such as checklist, SOP and example transfer protocol.

Detailed Comparison between EU & Indian GMP Requirements for APIs

According to a new EU directive as of Jan 2, 2013, all APIs imported  to the EU must have been manufactured in compliance with standards at least equivalent to the GMPs of the EU (ICH Q7). The new directive requires either a written confirmation from the national competent authority of the exporting country that the APIs manufactured there are compliant with GMP at least equivalent to EU standards, or the exporting country is on an approved list of non-EU countries that have been assessed by the EU or inspected by an EU member State to ensure they meet EU manufacturing standards. Because India is a major exporting country of APIs a comparison between EU and Indian  GMP standards is of utmost importance. Such a comparison has been developed and published on 141 pages by "Drug Regulations", an organization that provides free online resource to Pharmaceutical Professionals.

ICH Releases M7 Guidance for Mutagenic Impurities

On February 6, 2013, ICH has published Step 2 of the guidance: "Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk". The guide is built on requirements and approaches of already existing guides from FDA, EMA and industry task forces and has the potential to consolidate all of them into one global guidance.. To learn everything about regulatory requirements and analysis of genotoxic/mutagenic/carcinogenic impurities in drug substances and drug products including requirements of ICH M7 attend the Labcompliance audio seminar: "FDA/EMA Compliance for Genotoxic Impurities" and receive 10+ best practice guides for easy implementation  

FDA Warning: Paper print-outs of e-records incomplete, missing e-audit trail, no back-up of raw data

The warning letter was received by a pharmaceutical manufacturer. Primary deviations included: no back-up of raw data, printed copies of e-records do not include all raw data and metadata, e.g., no instrument control parameters, no security control of electronic data, SOP does not include provisions for audit trail reviews. The company had responded to all related 483 observations, but most responses have been inadequate for a variety of reasons. The Warning Letter can be downloaded from the Labcompliance Usersclub. Scroll down to W-273. Non members can preview excerpts. Attend the Labcompliance audio seminar to learn everything about FDA requirements to ensure integrity, security and availability of regulated electronic records.

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: Disaster Recovery of Computer Systems". To download your free copy, go to the Computer System Validation Package.. Scroll down and click on the corresponding ICON on the left (offer expires on May 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.

2-day In-Person Seminars with Dr. Ludwig Huber

Audio Seminar Schedule

  1. Elemental Impurities According to the Final USP Chapters 232/233
    With updates on the new ICH Q3D Guide: Elements, Limits and Schedule
    April 25, 2013
  2. Comparing GLP with GMP
    Learn about similarities and differences and when to apply one or the other
    May 7, 2013
  3. FDA/EMA Compliance for Genotoxic Impurities
    Understanding and Implementing the new ICH M7 and other Guidelines
    May 14, 2013
  4. How to Ensure Integrity of Laboratory Data
    Comply with new FDA inspection practices and EU Annex 11 requirements
    May 23, 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.