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Ten 2-day in-person seminars with 
Dr. Ludwig Huber

For titles, contents and dates, click here

 

 

71 New Usersclub Additions
last update
September 12, 2016

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

 

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

 

Understanding the Final FDA Guidance for Validation of Analytical Method

With 10+ best practice guides for easy implementation

July 14, 2016

 

FDA Compliant IT Infrastructure and Network Qualification 

With Strategies and Tool Kit for Compliance and System Uptime

Recorded, available at any time with all reference material

 

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

Recorded, available with all reference material at any time

 

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

Recorded, available with all reference material at any time

 

Integrity of Laboratory Data for FDA/EU compliance

Understand and implement data integrity through the entire data life cycle
Recorded, available at any time with all reference material

 

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

With focus on conducting risk assessment

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

 

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

 

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

 

FDA's New Enforcement of Part 11

Learn what the FDA is looking for and how to respond

Recorded, available at any time 

 

Qualification of Virtual Networks and Cloud Computing

With Strategies and Tool Kit for Compliance and System Uptime

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

 

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 methods for easy transfer and to avoid OOS situations

Recorded, available at any time

 

Managing Electronic Raw Data in Regulated Environments
Definition, generation, evaluation and archiving for FDA, PIC/S and EU compliance
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, available at any time

 

Managing Out of Trend Results in Pharmaceutical Quality Control

With Strategies and best Practice Guides for easy Implementation

Recorded, available at any time

 

Validation and Control of Excel Spreadsheets for FDA Compliance

Understand requirements and get tool kits for easy implementation

Recorded, available at any time

 

Comparing GLP with GMP

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

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 on demand

 

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

 

Validation of Analytical Methods according to the New FDA Guidance

Understanding FDA's New Lifecycle Approach Towards Method Validation

Recorded, available at any time

 

Understanding FDA's New Guide on Use of Electronic Source Data in Clinical Investigations
With tool kit for cost effective implementation

Recorded, available on demand

 

Transfer of Analytical Methods According to the New USP Chapter 1224
With SOPs, templates and examples for easy implementation

Recorded, available on demand 

 

FDA Compliant Handling of Out of Trend Results in Pharmaceutical Quality Control

With Strategies and best Practice Guides for easy Implementation

 Recorded, available on demand

 

System Suitability Testing for FDA and USP Compliance

Setting parameters and limits for chromatographic and other methods

Recorded, available on demand

 

Analytical Equipment Qualification and System Validation for FDA Compliance

Combining the USP <1058> with the new GAMP(TM) Laboratory Computer Systems Guide

Recorded, available on demand

 

Managing Electronic Raw Data in Regulated Environments

Definition, generation, evaluation and archiving for FDA, ICH, PIC/S and EU compliance

Recorded, available on demand

 

FDA Compliant Use of (Certified) Reference Material

Strategies for selection, purchasing, testing and documentation

Recorded, available on demand

 

Regulatory Aspects of 'Biosimilar' Drugs

Understand and Implement recent FDA and updated EMA Guidances

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

 

Qualification and Use of Virtual Networks in Regulated Environments

With Strategies and Tool Kit for Compliance and System Uptime

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

 

Learning from Recent Warning Letters Related to GMP Laboratory Controls

For Preparation of FDA and International GMP Laboratory Inspections

Recorded, available at any time

 

New  release
with 46 SOPs

 

CD for training and tools for easy implementation

 

 

With master plans, 31 SOPs, Checklists, Examples, Audio seminar

 

Comply with FDA's Current Interpretation

Reference book for
Part 11 Implementation

 

For FDA/EU Compliance of Excel Spreadsheets

With seminar presentations, primer, SOPs, checklists and examples

 


 

www.fdawarningletter.com

300 GxP related FDA

EIR's/483's and Warning Letters

 

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