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
On-line Audio Seminar 121
How to Comply with International GMP
Regulations and Guidelines
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
- 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
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
- Case study: computer validation
And for easy and instant implementation:
download 10+ documents from special seminar website or links
- International GMP inspections - Preparation, conduct, follow
- 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.
- 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
- 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
How to order
Replaced by the more recent seminar
How to Comply with International
Prepare Your Production and QC Lab
for International Inspections
About audio seminars
Online audio seminars are presented over the
phone. During the live presentation attendees can:
- Study the printed slide material
- Watch the slides on a computer
- Watch the slides on a video screen in a seminar room
- 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
||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,