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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 319

Basic and update Training on Good Manufacturing Practices

Ideal as Introduction for new Employees and as Refresher for all others

Recorded, available with all reference material at any time

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FDA and equivalent international agencies require documented and certified knowledge of GMPs for all personnel working in GMP environments. Typically such knowledge is is provided through initial GMP training for new and employees and through annual refresher training  for existing staff.  Lack of adequate training especially in the area of GMP knowledge is a key inspection issue as training plans should include basic and an-going GMP knowledge for everybody working in an FDA or international GMP environments. This includes all management levels and also IT staff and software developers. Typically trainees have many questions:.

Frequent Questions related Good Manufacturing Practices are:

  • What is GMP and cGMP?
  • Who has to comply with cGMP regulations?
  • Why is GMP so important?
  • What are the differences between FDA and international cGMP regulations?
  • What is the differences between GMP and non-GMP work?
  • What are the key GMP requirements?
  • What can be the consequences of non-compliance?
  • What are the responsibilities of operators, supervisor, QA and management?
  • Why do we need to follow SOPs?
  • How to document GMP records?
  • How to prepare the  staff for a GMP inspection?
  • What are the most frequently found inspectional deviations and how can we avoid them?

How does the audio seminar help:

Answers to the questions above will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will give an introduction on cGMP and the requirements. After the seminar, an extensive list of application specific reference material like SOPs, checklists, templates and examples will be available for further practice that  help immediate and effective implementation.

During the interactive presentation you learn about:

  • FDA and International GMP regulations
  • Understanding the business benefit of GMPs
  • Difference between GMP and non-GMP work
  • GMP for drug substances and drug products
  • Management and organizational requirements
  • Requirements for building and facilities: the importance of cleaning validation
  • Requirements for equipment and computer systems
  • Requirements for packaging and labeling
  • Responsibilities of management, QA, and all employees
  • Requirements for quality control laboratories
  • Required standard operating procedures and how to use them efficiently
  • Data generation and evaluation: raw data, intermediate results, final results
  • Records keeping: format, length of time, archiving and reprocessing
  • Learning from examples of most recent frequently found Warning Letters
  • Preparing for GMP inspections to avoid warning letters

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

  • 120 page-primer: Good Laboratory Practices and Current Good Manufacturing Practices
  • Gap Analysis/Checklist: Good Manufacturing Practice Regulations
  • Worksheet: Laboratory audits
  • SOP: Generation and Maintenance of SOPs
  • SOP: Handling Deviations from Standard Operating Procedures
  • SOP: FDA inspections - Preparation, Conduct, Follow-up
  • SOP: Training for GMP Compliance
  • SOP: Building a GMP System for International Environments
  • SOP: Facilities and Environmental Control
  • SOP: Equipment Qualification
  • SOP: Multinational GMP inspections - Preparation, Conduct, Follow-up
  • SOP: Corrective and Preventive Actions
  • Slide set with on-going global GMP updates
  • FDA Inspection Manual; Drug Manufacturing
  • Frequently asked questions and answers related to GMP
  • FDA and International GMP Regulations (drugs, devices)
  • 30+ GMP related FDA warning letters
  • FDA and ICH Guidance for APIs
  • The script of the presentation
  • The PowerPoint Presentation to train others.
  • And more...

GxP Regulations along the Drug Life

GMPs apply to Manufacturing and Quality Control of drugs and APIs. Attend the seminar to learn about the requirements

Who should attend?

  • Everybody working in GMP environments
  • QA managers and personnel
  • IT managers and personnel
  • Production and lab managers
  • Packaging and labeling
  • Manufacturing and shipping departments
  • Validation specialists
  • GMP Auditors
  • Consultants
  • Teachers

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.-
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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.

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,