GMP Webinar: Medical Software - Meaning of Apps, Websites and other Software for Pharmaceutical Companies
Course No 10339
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Speakers
Torsten Kneuss
Bayer Pharma AG, Berlin, Germany
Since 1999 Torsten Kneuss has been working with pharmaceutical packaging materials, including several years within the fields of packaging quality control and packaging development. Since November 2010 he has been Operations Manager, responsible for pre-filled syringes and medical devices. For the past two years he is also responsible for Medical Software, mainly the launch preparation of a system consisting of Patient Apps and Software for health-care professionals.
Background
The increasing number of Apps for Smartphones and other software types developed and distributed by pharmaceutical companies to patients, physicians or other customers brings a new product class to the industry. This new product class – software – potentially falls under the Medical Device regulations. If its intended use is covered by the definition of a Medical Device it needs to be developed and operated according to the requirements for Medical Devices, and it also needs to have a regulatory clearance.
The goal of this webinar is therefore to provide you with an overview about Medical Software, allowing you to evaluate whether there is a need for actions in your company.
Target Group
The webinar targets executives and staff from quality and information technology units who are in charge of Software with Medical purpose (e.g. Mobile Apps, Desktop Software, Websites). It also addresses Qualified Persons, responsible for the review and release of Medical Software or Combination Products.
Technical Requirements
To be able to take part in a Webinar, you need a computer with high-speed Internet access (i.e. DSL) and speakers.
Your Internet browser must have following features to use the GMP Webinar system:
1. Adobe Flash-Player must be installed.
2. Javascript must be allowed.
3. Port 1935 must be released.
Programme
The aim of the webinar is to provide you with an overview about relevant aspects of Medical Software:
Introduction – Software distributed by Pharmaceutical Companies
Medical Software vs. Promotional Software
Overview about regulations for Medical Software (mainly in EU and US)
Challenges with Medical Software
GMP Conferences by Topics
- General Quality Assurance and GMP Compliance Topics
- Hygiene
- General Microbiology Topics
- Regulatory Affairs
- Development
- General Analytics Topics
- Good Distribution Practice
- Sterile Manufacturing
- Computer Validation
- General Qualification/Validation Topics
- General Engineering Topics
- APIs/Excipients
- GMP Basic Training Courses
- Medical Devices and Combination Products
- Packaging and Packaging Material
- Data Integrity
- Qualified Person (QP)
- GMP Auditing
- Documentation
- Cleaning Validation
- General IT Compliance Topics
- Impurities
- OOS / OOE / OOT
- Material Testing
- Validation of Analytical Methods
- Analytical Instrument Qualification
- Stability Testing
- Microbiological Testing
- Technology
- General Manufacturing Topics
- Solid Dosage Forms/Semi-Solid Dosage Forms
- Biotechnology/Blood/ATMP
- Herbal Drug Products/Cannabis/Radiopharmaceuticals
- Others