Audio Seminars

Home | Contact Us | Newsletter | Usersclub | Books | Audio Seminars

 

Version 5 just released

Now with Qualification of Virtual Networks

With three audio seminars

With 28 SOPs

 

45 New Usersclub Additions
last update
April 30,2014

- 15 SOPs
- 10 Examples/Checklists
- 3 Forms/Templates
- 7 FDA Presentations
- 21 Warning Letters

 

Twelve 2-day In-person Interactive GMP and Validation seminars available in America, Europe and Asia delivered by Dr. Ludwig Huber. 

 

 

Online Audio Seminars come with 10+ Best Practice guides for easy implementation

 

Comparing GLP with GMP

Learn about similarities and differences and when to apply one or the other

June 5, 2014

 

Understanding the 'New' FDA Guide for Validation of Bioanalytical Methods
With SOPs, templates and examples for easy implementation
Recorded, available at any time

 

Validation and Use of Cloud Computing in FDA Regulated Environments

Comply with GXPs, Part 11, EU Annex 11 and other regulations

Recorded, available at any time 

 

Laboratory Equipment Calibration and Qualification according to USP <1058>

With SOPs, Templates and Examples for easy Implementation

Recorded, available at any time 

 

Understanding the New EU-GMP Annex 15 on Validation and Qualification

New requirements and strategies for implementation

Recorded, available at any time 

 

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
To share this seminar info with your colleagues, click here
.

On-line Audio Seminar 338

Recent Regulatory Updates in Pharma and Biopharma Compliance

Get a comprehensive update in just one hour.

Recorded, available with all reference material at any time

 

Order Button

Professionals in the pharmaceutical and biopharmaceutical industry must keep themselves up-to-date with ever changing regulations, guidelines, good-practice guides and inspection and enforcement practices.  While there are a lot of good resources available through literature publications, public conferences and seminars and through the internet it can be time consuming to find the right information on the internet and it could become expensive to attend conferences due to conference fees and travelling expenses. Wouldn't it be nice to have one source with all important update information to get answers to all your questions!

Key Questions related to Regulatory Updates are:

  • Are there are new or updated national or international regulations or guidances related to the (Bio)pharmaceutical industry?
  • Are there any important updates from global organizations such as ICH, WHO or PIC/S?
  • Are there new inspectional trends, observations and warning letters we should be aware of?
  • Is anything expected from European or United States Pharmacopeia?
  • Are there any new industry initiatives, e.g., from ISPE, PDA or DIA?
  • Are there any other trends we should be aware off?

How does the Labcompliance seminar help:

Answers to the questions above will be presented by Dr. Ludwig Huber in a new interactive audio seminar series. In just one hour, the speaker will give a comprehensive update on what's new in (Bio)pharmaceutical compliance  and gives practical recommendations for implementation. Attendees can ask questions before, during and after the live-presentation. Questions from before and during the seminar will be answered during the life session. The seminar will be complemented by a website with links to most important documents the industry should be aware off. Furthermore the website will offer best practice guides such as SOPs and checklists that help to better understand and implement new requirements.  The website will also post all questions and answers that  came up before, during and after the seminar. The reference material also includes slide material in convenient PowerPoint format for further in-house training.

During the interactive presentation you learn about updates from:

  • USP
    - USP 232/233 elemental impurities, new time line, comparison with ICH Q3D
    - Update on chapter 41 and 1251: Balances
    - New lifecycle approach for integrated validation and transfer of
      analytical methods and for verification of compendial methods.
  • Europe
    - New Annex 15: Validation and Qualification
    - Listing companies with inspectional deviations on the internet
  • FDA:
    - Guide: Validation of Analytical methods
    - Guide: Bioanalytical method validation
    - Update on FDA Inspections and other initiatives
    - Examples of recent 483 inspectional observations and/or warning letters
  • Joint FDA/EMA/international activities
    - Pilot program and Q&As on quality by design
    - Joint inspections, e.g., generic drug manufacturers
  • Miscellaneous
    - update on regulatory requirements for quality by design (QbD)
    - update on regulatory requirements for using cloud computing
    - update on global harmonization initiatives

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

  • Official guidance or drafts
    - EU-GMP Annex 15: Validation and Qualification (2014 version, draft)
    - FDA guide: Validation of Analytical methods (2014 version, draft)
    - FDA Guide: Bioanalytical Method Validation (2013 version, draft)
    - ICH Q3D on elemental impurities
  •  Labcompliance best Practice Guides
    - Checklist: Validation of Analytical Methods according  to
       the new FDA Guidance 2014
    - Checklist: Validation and qualification according to the new EU GMP Annex 15
  • FDA 483's and Warning Letters
    - Five new trend setting FDA Warning Letters from 2014
  • Others (links)
    - Press release: FDA to increase staff members in India
    - Biopharm Publication: FDA Updates Analytical Validation Guidance
  • Seminar slides and Q&As
    - Slides of the presentation as PPT files to train others
    - All questions and answers from before, during and after the seminar

Who should attend?

  • QA managers and staff
  • IT managers and staff
  • QC and other laboratory managers and staff
  • GMP/GCP/GLP auditors
  • Representatives of validation and metrology groups
  • Regulatory affairs
  • Training departments
  • Documentation department
  • Consultants

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 - CD

  • Get the CD in your mail
  • Useful if you can/could not attend the on-line seminar. Order includes all reference material.

US$ 399.-
Order Now Button

Recorded seminar - Download Version

  • Download from the Internet
  • Listen and learn whenever you want, wherever you want. Order includes all reference material.

US$ 399.-
Order Now Button

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.-
Order Now Button

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 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 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,