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 252

FDA Regulations for (Bio)Pharmaceutical Industry

Get an Overview on Principles and Key Requirements in just one Hour

Recorded, available at any time

US Federal Laws, FDA Regulations and FDA guidelines have a high impact on the Pharmaceutical and biopharmaceutical Industry. Development,  manufacturing and distribution of medicinal products must follow FDA regulations and guidelines. Everybody working in the regulated Pharmaceutical and Biopharmaceutical should have a basic understand what the regulations are and to which part of business they apply. Similarly, companies supplying equipment and any type of material should also have a good understanding to be able to understand requirements and speci9fic regulatory terms. There is lots of material available on the internet but information is far too much and there are no answers to specific questions. 

Key questions related to system suitability testing are:

• What are the most important FDA regulations for (Bio)Pharmaceutical Industry?
• What is the difference between US federal laws and FDA regulations
• Why does the FDA have so many regulations, wouldn't one be enough?
• What regulations apply to my work?
• What is the main difference between regulated and non-regulated work?
• What is the difference between FDA regulations and guidelines?
• Our factory is outside the United States, when do we have to comply with FDA regulation?
• When should suppliers comply with FDA regulations?
• Is there a difference between regulations for traditional pharmaceutical industry and Biopharm industry
• How can suppliers help regulated clients to comply with FDA regulation?
• What can happen if we fail an FDA inspection?
• When and how are regulations enforced?

How does the this audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. In just one hour the speaker will give an overview of different FDA regulations and how they apply to the different pharmaceutical businesses . After the seminar, an extensive list of example documents will be available to get a good understanding of  the documentation effort.

During the interactive presentation you learn about:

• The role of FDA vs. ICH and USP
• The US Food, Drug & Cosmetic Act - The starting point
• Type and objectives of FDA regulations for development, manufacturing, quality control and distribution of drugs and drug substances
• Key requirements of different FDA regulations: GLP, GCP, GMPs
• Specific regulations for the BioPharm industry
• The main difference between regulated and non-regulated work
• The meaning of regulations versus guidelines
• Submission and approval of drugs: procedures, timing, costs
• Consequences of npn-compliance
• FDA Inspection approach and documentation
• Impact of FDA regulations on foreign manufacturers
• Resources for more on-going information

And to get an impression on FDA language and documentation requirements download 10+ example documents from special seminar website

• Example for a Standard Operating Procedure
• Example for a test protocol
• Example for a supplier assessment form
• Example for regulatory text
• Example for an FDA guideline
• Example for a 483 form inspectional observation
• Example for an establishment inspection report
• Example for a Warning Letter
• Example for an assessment checklist
• Example for a computer incident form
• Example for a change control form
• Example for an FDA presentation

Who should attend?

• (Bio)Pharmaceutical API Industry
• Everybody working in FDA regulated industry
• Suppliers of computer systems and equipment
• Suppliers of starting material for (Bio)pharmaceutical industry, e.g., suppliers of raw material and drug substances
• Documentation departments
• Training departments
• Consultants

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.

Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:  Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,