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Version 4 just released

With strategies and tools for fast, cost-effective Laboratory Accreditation

With Quality Manual and  SOPs for easy implementation

 

New Usersclub Additions
last update
May 24, 2016

 

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

 

Understanding the New FDA Data Integrity Guidance
With examples and procedures for effective implementation
June 2, 2016

 

Understanding the new Revision of USP <1058
With examples and procedures for effective implementation

June 15, 2016

 

Integrity of Laboratory Data for FDA/EU compliance

Understand and implement data integrity through the entire data life cycle
June 23, 2016

 

Quality by Design (QbD) for Development and Validation of Analytical Methods

With focus on conducting the risk assessment process

Recorded

 

Ensuring Data Integrity for FDA/EU Compliance
Comply with FDA Part 11 and EU/PICS Annex 11 for paper, electronic and hybrid records
Recorded, available with all reference material at any time

 

Learning from Recent Warning Letters related to Part 11 and Computer Validation

With Clear Recommendations for Corrective and Preventive Actions

Recorded, available at any time

 

Understanding the Final FDA Guidance for Validation of Analytical Methods

With 10+ best practice guides for easy implementation

Recorded, available at any time

 

Analytical Instrument Qualification According the new Revision of
USP <1058>
 

With SOPs, Templates and Examples for easy Implementation
Recorded, available at any time

 

Transfer of Analytical Methods According to New FDA, USP and EU-GMP Guidelines
With SOPs, templates and examples for easy implementation
Recorded, available at any time

 

Ensuring Data Integrity for FDA/EU Compliance
Comply with FDA Part 11 and EU/PICS Annex 11 for paper, electronic and hybrid records
Recorded, available at any time

 

Quality by Design (QbD) for Development and Validation of Analytical Methods

Learn how to design robust analytical for easy transfer and to avoid OOS situations

Recorded

 

FDA/EU Compliant Handling of OOX Test Results

Learn how to investigate out-of-trend (OOT) and out-of-expectation (OOE) vs. OOS results

Recorded

 

FDA/EU Compliant IT Infrastructure and Network Qualification

With Strategies and Tool Kit for Compliance and System Uptime

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 Quality by Design for the Pharmaceutical Industry

Introduction to Principles, Regulatory Activities and Industry Practices

Recorded, available at any time

 

Impact of Quality by Design on the Analytical Laboratory

Learn through examples on development and validation of analytical procedures

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 on demand

 

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

 

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.

 

 

 

Record Attendance at the New Computer Validation and Part 11 Seminar

The seminar "Validation and Part 11 Compliance of Computer Systems and Data was held in the Mumbai Leela in April 28/29. It was conducted by Dr. Ludwig Huber of Labcompliance and attended on both days by 270+ midrange and senior managers from API, Pharma and Medical Device Companies. According to the organizer NetZealous/Global CompliancePanel if was the best attended in-person seminar of the company ever. Most likely it also was the best attended FDA compliance seminar presented by a single person. To see the press release of NetZealous/GlobalCompliancePanel, click here, to read more about the event on the Labcompliance website, click here.

The conference room was filled with 270+ delegates on both days

FDA expects Interim Compliance Solutions during Part 11 Upgrades

When non-compliant systems are upgraded, FDA expects an interim solution until the upgrade is functioning. This became obvious from a warning letter describing a situation where a non-compliant system was upgraded and the non-compliant system was used until the new system was full functioning. The warning letter reads: "Laboratory data generated by the Karl Fischer autotitrator software was not restricted. The program used to run your autotitrator is unable to record audit trails and cannot support accounts with unique user names and passwords for individual users. We acknowledge your commitment to upgrade to a compliant software package. However, your response is inadequate because you failed to provide an interim solution prior to its installation." The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 302).  To learn everything about FDA expectations for data integrity, attend the Labcompliance audio seminar  "Ensuring Integrity of Laboratory for FDA/EU Compliance".

USP Publishes a Second New Revision of Chapter <1058>

The its launch in 2008 the USP <1058> entitled Analytical Instrument Qualification (AIQ) has evolved as the golden global standard for analytical instrument qualification, despite of some deficiencies of the first version. For example the industry had difficulties to apply the sections on three equipment categories and for systems comprising equipment hardware and computer systems. And there have always been comments about not enough details for the four qualification phases. About a year ago USP has published a first new revision of the chapter. Now the second revision has been published with inputs from the industry. This is expected to be close to be more close to the final chapter. Attend the new Labcompliance seminar to learn everything about the new requirements and get best practice guides for easy implementation.

Hong Kong SAR / PPBHK and Croatia / HALMED accede to PIC/S

In  January 2016, the Pharmacy and Poisons Board of Hong Kong SAR (PPBHK) as well as the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) became the 47th and 48th PIC/S Participating Authorities.

USP Revises Chapter <232> on Limits of Elemental Impurities

The chapter is being revised to address comments received and to further align this chapter with ICH Q3D. USP’s Elemental Impurities Expert Panel approved a recommendation to the General Chapters—Chemical Analysis Expert Committee that this chapter be revised to align with the ICH Q3D Step 4 document to the greatest extent possible. Therefore, this revision is being proposed to include additional elements and their specific limits in this chapter. Additional changes are made to provide clarity on the topic of risk assessment. The revised chapter has been published in Pharmacopeial Forum 42(2), Mar/Apr, 2016

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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.