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 121

How to Comply with International GMP Regulations and Guidelines

U.S. FDA/EU/Japan/TGA/WHO

Recorded

Healthcare products marketed to a specific country should comply with GMP regulations of that country, no matter where the products have been developed and manufactured. Unfortunately GMPs are not identical within all countries. On the other hand global pharmaceutical companies want to market products to as many countries as possible to leverage high development costs. It is just impossible to develop different procedures for each target country, therefore a good understanding of common requirements is important, but also differences.

Key Questions related to national and international GMP regulations are:

• What is the key difference between GMPs worldwide
• What is the difference to FDA regulations?
• Are there any specific requirements in guidance documents we should care about?
• What are common requirements?
• What are inspection practices in international countries?
• What are the requirement and responsibilities for the 'qualified person' in Europe?
• How to write documentation that it is acceptable by all agencies?
• In which language should I prepare all my documentation?
• Does ICH 7QA Replace 21 CFR Part211 for APIs?
• We developed procedures for US FDA. Is this good enough for all international GMP regulations?
• How to prepare for inspections from multiple countries?
• Where can I get all these international regulations and guidelines?

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 give practical recommendations. After the seminar, an extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation of global GMP systems.

During the interactive presentation you learn about:

• Most important international GMP regulations and guidelines
• Major differences to FDA GMP regulations
• Common elements of all GMP regulations
• The role of the 'qualified person' in European GMPs
• International Inspection practices across the globe
• Developing processes that meet all international GMPs
• Preparing for FDA and international inspections
• Writing documentation that fits all regulations and guidelines
• Case study: computer validation

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

• SOPs:
  - International GMP inspections - Preparation, conduct, follow up
  - Building a GMP System for International Environments
  - Development and maintenance of SOPs
  - Qualification of Equipment
  - Training for GxP, 21 CFR Part 11 and Computer Validation
• Gap Analysis/Checklist:
  - Good manufacturing practices
• Warning letters and Inspectional observations.
• Primers
  - Basics of GLP, GMP and equipment and computer validation. An excellent training tool for beginners (120 pages).
  - Fundamentals of successful compliance training (31 pages)
  - Making the best out of FDA inspections (72 pages)
• EU - Good Manufacturing Practices
• ICH - Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
• Other publications

Event materials will be available a day ahead of time for photocopying or electronic distribution,

Who should attend?

• QA managers and personnel
• Analysts and lab managers
• Validation specialists
• Regulatory affairs
• Human resources (HR) managers and staff
• Training departments
• Documentation department
• Consultants

How to order

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

Recorded seminar - Web download 'Site' offer 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$ 349.-
Recorded seminar - CD Get the CD in your mail Order includes all reference material.	US$ 349.-
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$ 249.-

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.