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62 New Usersclub Additions

- 19 SOPs
- 21 Examples/Checklists
- 8 Forms/Templates
- 2 Master Plans
- 12 Warning Letters 

last update
April 10,  2017

 

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

 

 

Validation and Control of Excel Spreadsheets for FDA Compliance
Understand requirements and get tool kits for easy implementation

May 3, 2018

 

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

With focus on the analytical lifecycle
Recorded, available at any time

 

FDA Compliant IT Infrastructure and Network Qualification 

With Strategies and Tool Kit for Compliance and System Uptime

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

 

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

Recorded, available at any time

 

Understanding the New FDA Guidance for Validation of Analytical Methods

With 10+ best practice guides for easy implementation

Recorded, available 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

 

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

 

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 the New FDA Data Integrity Guidance
With examples and procedures for effective implementation

June 22, 2017

 

Contingency and Disaster Recovery Planning for Computer Systems
To Ensure Business Continuity and Compliance
June 26, 2017

 

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

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

 

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

 

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

 

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

 

 

 

May 2018

Focused Stakeholder Consultation for Draft PIC/S Guidance on Data Integrity 

The PIC/S Working Group on Data Integrity, co-led by Australia / TGA and UK / MHRA, has revised the Draft PIC/S Guidance on Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments. The purpose of the guidance is to serve to outline the position an inspector would adopt during the inspection of GDP/GMP facilities and is designed to facilitate a harmonized approach to the inspection, including reporting in regards to data management and integrity. A first draft (PI 041-1 (Draft 2)) was published by PIC/S on a trial basis in August 2016. Following feedback received from PIC/S Participating Authorities during its 6-month implementation trial-period, the draft of this guidance has been updated and expanded by the Working Group. More information can be found in the PIC/S 2018 meeting report.

Pakistan Applies for PIC/S Pre-Accession

The Drug Regulatory Authority of Pakistan (DRAP) applied for PIC/S pre-accession on 18 September 2017. A Rapporteur is to be appointed by the Committee.

FDA Warning Letter recommends restricting access to computer system, and always enabling audit trail function

The warning letter was going to Chinese a API manufacturer as as result of a follow-up inspection from 2015. None of the following 2015 deviations have been implemented: - Enabling the audit trail function on laboratory electronic instruments; - assigning unique user names and passwords for each staff member; and authorizing (b)(4) levels of accessibility to prevent electronic data from being deleted, removed, transferred, renamed or altered, failures to maintain complete data derived from all laboratory tests conducted to ensure your API and intermediates comply with established specifications and standards. In addition the companies quality unit failed to review and approve all appropriate quality-related documents. For example the quality unit approved the certificate of analysis (COA) for release of an API batch to a customer before testing was complete and available for review. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 313).

 

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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.