Home | Contact Us | Newsletter | Usersclub | Books | Audio Seminars


 

62 New Usersclub Additions

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

last update
August 3, 2018

 

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.

 

 

 

August 2018

PIC/S Adopts four New Guidance Documents from EU

On June 2018 the following new PIC/S Guidance documents have been adopted: PIC/S Guidelines on the formalized risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use (PI 045-1); PIC/S Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities (PI 046-1); PIC/S Guidelines on the principles of Good Distribution Practice for active substances for medicinal products for human use (PI 047-1).
These PIC/S Guidelines transpose for PIC/S purposes the corresponding European Commission (EC) guidance documents. This transposition further strengthens harmonization between PIC/S and the EU

Drug  Manufacturer Cited for Releasing Products Without Testing

During a inspection of a drug manufacturing facility the FDA found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API).. For example a related warning letter reads: Failure to perform laboratory testing of API to ensure conformance to specifications and to accurately report results on certificates of analysis (COA). The laboratory notebooks lacked the analytical data to support the information on your COA. Although your COA states that the identity tests “Passed,” you did not perform the tests" and "Although you never performed the required testing, you distributed these API lots to the U.S. market with false information on the COA.
Based upon the nature of the violations FDA strongly recommend engaging a consultant qualified as set forth in 21 CFR 211.34 to assist the firm in meeting CGMP requirements. The warning letter can be downloaded from the Labcompliance Usersclub. Non members can preview excerpts (scroll down to 315).

New or Updated Sites

Click here to tell others in your company about compliance news

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.