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Duration: 50 min. + 10 min. Questions Time.

Regulation 745/2017 on Medical Devices: technical file structure

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  Description:

The course is aimed at staff of Quality Assurance, Regulatory and Research and Development of biomedical companies manufacturing of sterile medical devices, their suppliers and subcontractors.

The course includes a theoretical introduction to the concept of sterilization and a description of the main sterilization methods used currently; also are provided background informationof the validation of the packaging for the maintenance of sterility over time.

This live webinar course will provide guidance on medical device sterilization processes. In Particular will discuss the following points:

1. Definition of Sterility
2. Main methods : EtO , gamma , steam
3. Maintaining the sterility and shelf life

LEVEL: INTERMEDIATE (Requires basic knowledge about medical device).

Why You Should Attend:

“Sterilization means the use of a physical or chemical procedure to destroy all microbial life, including highly resistant bacterial endospores.”

Bacterial spores are the most resistant of all living organisms because their capability to withstand destructive agents.

Although the chemical or physical process used to destroy all pathogenic microorganisms including spores is not absolute, when all parameters of the sterilization process have been met, instruments, supplies and equipment are thought to be sterile.

Critical objects (those that enter sterile tissues or the vascular system or through which blood flows, such as implanted medical devices) require sterilization before use. Items that touch mucous membranes or nonintact skin, like endoscopes, respiratory therapy equipment, and diaphragms, require high-level disinfection.

Sterilization falls into the following three categories:

• High temperature/pressure sterilization (autoclave)

• Chemical sterilization

• Radiation sterilization .

AVAILABLE ALSO ON DEMAND

Fill the form below to schedule the on demand live webinar session:

Who Will Benefit:

• Sterility Assurance
• Manufacturing
• Quality Control
• Quality Manager
• Quality Engineer
• Regulatory Affairs specialist
• R&D Engineer
• Pharmaceutical Engineer
• Validation Engineer
• Process Engineer

Certification Requirements:

Students must view the entire program and successfully pass an online, multiple choice final assessment with >80% passing grade.Certificate will be printable in PDF format immediately after satisfying requirements.

Online Training Programs Includes:

• Answer to questions submitted during the webinar.
• An online final assessment with multiple choice questions.
• A Certificate of Completion.

Live Course Presented and Commented by:

Alice Ravizza is a Biomedical Engineer, graduated at Politecnico di Milano. She has great and extensive experience in R&D and QA / RA in the biomedical field. She is specialized in supporting Medical Device companies in building up and improve Quality System Management and assure Compliance through all the internal processs. She assist companies during the registration process for CE Mark making sure all the technical documentation is compliant to applicable standards and regulations. She is aswell an experienced Trainer and Lecturer.

Promotion:

Send email to info@mdpharmacourses.com to get the discount code.