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..

On-line Audio Seminar 241

The Qualified Person in the Pharmaceutical Industry

Understanding Qualification Requirements, Tasks, Duties and Responsibilities

Recorded

 

The Qualified Person (QP) as required by European regulations decides on batch releases of medicinal products. Batches are certified for release after a thorough verification that the batch has been manufactured according to relevant GMP regulations. With this duty the QP has to oversee a lot of activities and the role and responsibilities of the QO has been increasing over the last few years. Because of the importance of QPs it is very important for all companies marketing to Europe to fully understand the QP qualification requirements and to document tasks and duties but there are also many questions.

 Key Questions related to the Qualified Person.

• What are the qualification requirements for a QP
• Are the qualification requirements the same in all EU member countries?
• What is the QPs equivalent in FDA regulated industries?
• How does one become a qualified person?
• Does an API manufacturer need a QP?
• Are the "Authorized Person" as required by WHO and the "Qualified Person" the same?
• What is the role of the QP in process and computer,validation?
• What is the role of the QP in investigational medicinal products?
• What is the role of the QP for imported medicinal products?
• Can QP tasks be delegated to substitutes?
• When should the QP get involved during failure investigations?
• Are QP's personally liable for their mistakes and is this a problem in practice?

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.

During the interactive presentation you learn about:

• The regulatory system for medicinal products in Europe
• Regulatory  background of the QP person
• Overall tasks and responsibilities
• Qualification requirements common to all EU member countries
• Requirements for specific member states
• How to become a QP
• The QP and API manufacturing
• The role of the QP in the whole manufacturing process
• The importance of a QP for imported products
• The role of QP in process and system validation
• The QP and investigational medicinal products
• Delegation of tasks
• A QP's involvement for supplier qualification
• Comparison with QCU/QA Director in FDA regulated industry
• Personal liability

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

• PowerPoint Presentation
• Script
• All questions and answers from before, during and after the seminar
• SOPs:
  - Tasks and Responsibilities of the Qualified Person
  - Multinational GMP Inspections: Preparation, Conduct and Follow-up
• Examples
  - Checklist: The Qualified Person in the pharmaceutical industry
• Case Study: Job Description for the Qualified Person According to European GMPs
• Regulatory reference documents:
  - EU regulations related to the qualified person
• EU Qualified Person Association - QP Regulations -Legal Basis for Qualified Persons in Europe. (link)
• EU Qualified Person Association - Publications/Question and Answer Documents (link)
• Reference Article: Role of an Eligible Qualified Person (link)
• Detailed example of a regulatory requiement for qualified person (link)
• Study Guide: Qualified Persons in the Pharmaceutical Industry (link)
• And more

Who should attend?

• Everybody being interested in becoming a Qualified Person
• Everybody dealing with Qualified Persons
• QA managers and personnel
• IT managers and personnel
• Production and lab managers
• Manufacturing and shipping departments
• Validation specialists
• GMP Auditors
• Consultants
• Teachers

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 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.