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


 

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

For titles, contents and dates, click here

 

62 New Usersclub Additions
last update
December 1,  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

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 with all reference material

 

Understanding the New FDA Data Integrity Guidance
With examples and procedures for effective implementation
Recorded, available at any time with all reference material

 

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

Recorded, available at any time with all reference material

 

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 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.

 

 

 

December 2016

Questions and Answers related to Laboratories published by an MHRA laboratory inspection team member

Lynsay Hunter, a member the MHRA laboratories inspection team published  questions and answers that have been brought up at the Annual laboratories symposium held in Birmingham, UK, on September 22, 2016. More than 20 questions and answers have been published through the weekly GOV.UK Weekly Digest Bulletin. The article also includes an e-mail address to submit additional queries on the symposia content, or on other regulatory topics which were not covered at the symposia,

Thai FDA joins PIC/S

The PIC/S Committee invited Thailand’s Food and Drug Administration (Thai FDA) to join the Scheme. Thai FDA became PIC/S’ 49th Participating Authority. Thai FDA applied for a second time for membership in March 2015. A paper assessment was conducted in view of its accession to PIC/S, followed by an on-site visit in March 2016. For the complete press release and other PIC/S news click here.

10 New In-Person Seminars in 2017 with Dr. Ludwig Huber

Labcompliance has extended the offerings for in-Person workshops in several areas: "Data Integrity: FDA/EU Requirements and Implementation", "Validation and Part 11 Compliance of Computer Systems and Data", "GMP Compliance for Quality Control and Contract Laboratories", "Analytical Method Validation, Verification and Transfer", and "Analytical Instrument Qualification and System Validation". All workshops can be delivered as public and as in-house workshops. Currently the workshops are offered in USA, Europe and Asia. For a complete list of workshops with ordering process and links to pages with individual contents, click here.

.

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.