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.
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US$ 399.-

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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.-

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About audio seminars

Online audio seminars are
presented over the phone. During the live presentation attendees
can:
- Study the printed slide material
- Watch the slides on a computer
- Watch the slides on a video screen in a
seminar room
- 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.
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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.