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
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On-line Audio Seminar 335

Understanding Quality by Design for the Pharmaceutical Industry  

Introduction to Principles, Regulatory Activities and Industry Practices

Recorded, available with all reference material at any time

While Quality by Design (QbD) principles have widely been used to advance product and process quality in many industries, now they also are increasingly adopted by the Pharmaceutical industry for development and commercialization of drugs to improve process efficiency and product quality. For example the  US FDA and the EU EMA are driving QbD principles through common FDA/industry pilot programs and through incentives such as faster new drug approvals. While several QbD based new drugs have already been approved the majority of the industry is unsure what QbD really means and how to implement it.

Key Questions related to QbD are

• What is QbD?
• What is the difference to conventional processes?
• Are there examples for the related terminology such as Critical Process Parameters (CPP), Critical Product Attributes (CPA) or Design Space?
•  What are the be benefits for the industry?
• Is QbD required by regulations?
• Why is FDA so much interested in QbD?
• Why is risk assessment so important?
• How to define the design space?
• What are the elements of the QbD based drug development process?

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. After the seminar, an extensive list of reference material like SOPs, test scripts, templates and examples will help immediate and cost effective implementation. The seminar lasts one hour and will be conducted over the phone and supported by the Internet.

During the interactive presentation you learn about:

• History and regulatory background
• FDA and EMA co-operation
• ICH Q8/Q9/Q10/Q11-Guidelines – The foundation for QbD
• Principles and key benefits for patients, industry and FDAs
• QbD elements and terminology
• Comparison with conventional processes
• Going through the QbD process and steps for drug development
• The role of risk assessment
• Defining the design space
• The right control strategy: Real time release testing vs. end product testing
• monitoring and improvement
• Specific requirements for generic drugs
• FDA recommendations for submission
• Industry concerns and activities

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

• Checklist: Implementing Quality by Design in the Pharmaceutical Industry
• Publications related to QbD in the pharmaceutical industry (links)
• FDA presentations related to QbD in the pharmaceutical industry (links)
• Industry presentations related to QbD in the pharmaceutical industry (links)
• Slides of the presentation as PPT files to train others
• Script of the presentation
• All questions and answers from before, during and after the seminar

Steps for QbD in Pharmaceutical Development

All steps are very well discussed in the seminar

Who should attend?

• Operation managers and staff
• QA managers and personnel
• Regulatory affairs
• Training departments
• Documentation department
• Consultants
• Validation specialists

Date, time and duration

Recorded seminar, available at any time with all reference material

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.-

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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 editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

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 visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.

 

. Ludwig Huber in Panel Discussions with FDA Officials

George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference Smith and Huber discussed and answered questions about computer system validation and e-records.

	Ludwig Huber (right) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference. Mr. Murray explained FDA's next steps for Part 11
	Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:  Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,