Regulatory Compliance | English Recording (10271)

Background
Regulatory compliance is the mutually conformity of the respective (local) marketing authorization (including ASMFs and CEPs) with the manufacture and release of active pharmaceutical ingredients and medicinal products over the whole life cycle. It covers the areas development, manufacture, control strategy and stability and respective monitoring and verification activities. Most of these activities are responsibilities of the MAH as recently confirmed in a (draft) reflection paper (EMA/457570/2019) issued by the EMA (GMP/GDP Inspectors Working Group). These Regulatory/GMP obligations start with the submission of the marketing authorization application. At that time, the applicant must already ensure that details provided in the dossier are reflected in the data established and activities performed so far. These requirements are continuous, for the entire life cycle of the medicinal product, and the marketing authorization holder must ensure regulatory compliance throughout the life cycle of the medicinal product. Important questions in this context are:

• Are all processes in place to ensure that GMP certificate remains current?
• Are deviations and changes appropriately processed and communicated?
• Does the manufacturer have all the necessary information? ... dossier?
• Are (new) regulatory requirements implemented appropriately (...ICH Q8, life cycle concepts, validation requirements, …)
• Are approval requirements and obligations fulfilled (stability studies, validations, ....)?
• Processes in place according to ICH Q12 ....
• Risk management system adequate?... Continuous review!
• All data integrity requirements met?... also at all levels of delegated activities?

Type of Training
The training is not only designed for less experienced participants but is also very well suited to deepen and consolidate existing knowledge for more experienced participants. The training is provided in English.

Who should participate?
Personnel with responsibilities for pharmaceutical quality systems, change control, batch release, testing and stability testing. Members RA-CMC teams responsible for the information provided in the dossier and respective variations. Quality assurance personnel with focus on monitoring and verification activities.

Format
With this training, you receive the content in an e-learning format. You can listen to and watch the lecture comfortably on your computer screen. Conveniently, no matter where you are. Since it is a recording, you can choose and schedule your own training times and interrupt at any time if necessary.

Via the email address fragen@alphatopics.de you can ask questions to the trainer at any time by email and get them answered - if necessary, also by phone. This is included in the training fees.

Duration: 180 minutes
Lecture language: English | Slides: English

...more from your speaker Dr. Markus Veit...

Webinars allow you to participate in training courses and lectures conveniently from anywhere at any time. They are the perfect way to keep up to date with the latest knowledge without much effort. You are also welcome to ask the speaker questions after the webinar.

Note on contingent call-off: When booking this webinar described here, two units will be deducted per participant.

For team training, please contact us.