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All documents shown here are included in the seminar for instant download

 

 

 

 

 

Analytical tools for Characterization of Biotechnology Products and Processes (link) 

Learn from FDA Warning Letters what inspectors look for and what mistakes other companies make so you can avoid them

 

 

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 268

FDA Compliance for Biopharmaceutical Laboratories

Become familiar with FDA regulations and get tool kits for implementation

Recorded, available with the reference material at any time

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There is a clear trend In the pharmaceutical industry from small to large molecule based drugs. With the move of drugs from research to development and manufacturing compliance becomes more and more important. Scientists and and analysts working in biopharmaceutical laboratories  should be aware of specific requirements . US and most international countries have regulations with specific sections for laboratories. However, regulations only tell you what to do but not how to implement. So there are many questions.

Key Questions related to Regulated Biopharmaceutical are:

  • What are the most important FDA and international regulations and guidelines?
  • When in drug product developments does each regulation apply?
  • Is drug discovery regulated?
  • What are the key differences between regulated and non-regulated laboratories?
  • Which procedures do we need?
  • Which laboratory records should be retained for how long?
  • What and how to validate methods and qualify equiment
  • How to most effectively implement compliance on laboratories?
  • How to best prepare for FDA inspections
  • What are the incremental costs of compliance?

How does the audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. This semimar is intended to introduce biochemists and biologists working in biopharmaceutical development and quality control laboratories to FDA and equivalent international requirements. It is also useful for quality managers and staff and for everybody else involved in the registration process of biopharmaceuticals. The seminar will also give strategies and specific recommendations for regulated laboratories. In addition attendees will get tool kits for effective implementation. ..

During the interactive presentation you learn about:

  • Key difference between regulated and non-regulated laboratories
  • The most important regulations and guidelines related to biopharmaceutical laboratories
  • The compliance "hot-spots" the FDA investigators look for during inspections
  • Regulations as they apply to different lifecycle phases: GLP, GCP, cGMP
  • Requirements along the sample workflow, from sampling to testing, data evaluation, reporting and data archiving
  • Qualification of equipment and validation of analytical methods
  • Eight essential steps for effective implementation
  • Internal audits as an ideal preparation for FDA inspections
  • Incremental Costs of Compliance

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

  • PowerPoint Presentation
  • Script of the presentation
  • 70-page primer: Compliance for Biopharmaceutical Laboratories
  • 70-page primer: Analytical Instrument Qualification and System Validation
  • 70-page primer: Validation of Analytical Methods
  • SOP: Archiving and Retrieval  of GMP Data and other Documents
  • SOP: Training of Laboratory Personnel
  • SOP: Generation and Maintenance of SOPs for Laboratories
  • SOP: Validation of Bioanalytical Methods
  • Checklist: FDA Requirements for Biopharmaceutical Laboratories
  • Regulatory reference documents: Required Records for Laboratories
  • ICH Q6B: Test Procedures and Acceptance Criteria for Biotechnological/biological Products
  • Reference Paper: Analytical tools for Characterization of Biotechnology Products and Processes (link)
  • FDA warning letters and Inspectional observations related to laboratories.
  • FDA and International guidance documents and predicate rules

Who should attend?

  • Biochemist and Biologists working in biopharmaceutical laboratories
  • Documentation professionals
  • QA managers and personnel working for 'bio'pharmaceutical companies
  • Analysts and lab managers
  • Human resources (HR) managers and staff
  • Training professionals
  • Consultants

Date and time

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.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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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.

Dr. 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 explined FDA'snext 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,