Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here..

 

On-line Audio Seminar 236

Simplify Validation and Qualification with ASTM E2500

Cost Effective Alternative for Equipment Qualification and System Validation

Recorded

ASTM E2500 has been released in 2007 as a simplified approach for equipment qualification and system validation. It describes a science and risk based approach and is in line with ICH Q8,  ICH Q9, and with FDA's initiative Pharmaceutical cGMPs for the 21st Century.  ASTM E2500 is one of the most important changes in our industry and the benefits for cost effective equipment qualification are obvious, but how can we get there, and is it accepted by FDA and international agencies? There are also many other questions.

Key Questions related to ASTM E2500 are:

• What is the difference between ASTM E2500 and traditional qualification models?
• What is the difference between verification, qualification and commissioning?
• Is the standard applicable to laboratory equipment and systems?
• Is ASTM E2500 applicable to our networks?
• Is there a legal relevance for ASTM E2500?
• Is E2500 accepted by the FDA and international inspectors?
• Can we apply the standard for retrospective validation of existing systems?
• How does it compare with USP <1058> or GAMP 5?
• What are the roles and responsibilities of subject matter experts and QAU
• What are the potential cost savings?
• What should we expect from vendors?
• The standard does not require IQ, but how to document installation?
• What does 'Fit for Intended Use' really mean?
• Are there tools to implement E2500?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and an overview and give practical recommendations. He also will give clear recommendations on when the standard should be used. After the seminar, an extensive list of reference material like SOPs, test scripts, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

• FDA requirements and enforcement practices for equipment and systems
• Background and history of the standard
• The legal relevance for the standard
• The role of FDA and international agencies
• Understanding: Verification vs. qualification, commissioning
• Overview of the ASTM E2500 processes and steps
• Similarities and differences to USP <1058> AIQ and GAMP 5
• Correlation to ICH Q8 and Q9
• Roles and responsibilities of Quality Assurance Unit and Subject Matter Experts
• Potential overall savings
• Retrospective qualification of existing equipment/systems
• Step-by-Step implementation
• Common Pitfalls and frequently asked questions

And for easy and instant implementation:
download 10+ documents from special seminar website

• PowerPoint Presentation
• Script
• All questions and answers from before, during and after the seminar
• Example SOPs:
  -  Equipment and System Verification According to ASTM E2500
  -  Vendor Assessment According to ASTM E2500
  -  Risk Assessment for GxP Systems
  -  Development of User Requirement Specifications (URS) for Equipment
  -  Development and Maintenance of Test Scripts for Equipment
• Checklist: Implementing ASTM E2500
• 10 Templates specifically for ASTM E2500
  - ASTM E2500 Project Plan
  - Identification of Subject Matter Experts for ASTM E2500
  - Project Schedule for ASTM E2500
  - Documenting Requirements for ASTM E2500
  - Justification and Documentation of System Risk for ASTM E2500
  - Documenting Vendor Assessment for ASTM E2500
  - Verification of Proper Installation for ASTM E2500
  - ASTM E2500 Verification Plan
  - Test Protocol for ASTM E2500
  - Summary Report for ASTM E2500
• Example: Supplier Assessment According to ASTM E2500
• 5 FDA Warning Letters and Inspectional observations related to equipment qualification and system validation.

Who should attend?

• Biopharmaceutical and Medical Device
• Validation professionals, practitioners and mangers
• Operations professionals and managers
• Engineering professionals and managers
• Laboratory managers and staff
• QA managers and personnel
• Regulatory affairs
• Training departments
• Documentation department
• Consultants
• Directors/VPs of Operations
• Project Managers

Date, time and duration

Order at any time, replay at any time, download the reference material at any time.

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download Multiple persons - single site Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site. Order includes all reference material.	US$ 399.-
Recorded seminar - CD Get the CD in your mail Order includes all reference material.	US$ 399.-
Special offer for Labcompliance Usersclub Members Recorded Seminar- CD or Web download. Order includes all reference material. for Usersclub information and registration, click here	US$ 299.-

About audio seminars

 

Online audio seminars are presented over the phone. During the live presentation attendees can:

1. Study the printed slide material
2. Watch the slides on a computer
3. Watch the slides on a video screen in a seminar room
4. Ask questions through email and web form

 

About Dr. Ludwig Huber

Dr. Ludwig Huber is the author of the Labcompliance Newsletter. He has been conducting over 100 web and audio or video based seminars since ten years. He is worldwide director for FDA compliance at Agilent Technologies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visits FDA in Rockville, VA, and participates in panel discussions with FDA professionals. For more information, click here.