Implementation of ISO 13485 MasterClass

Name: Implementation of ISO 13485 MasterClass OCT
Brand: GLC Europe
SKU: event
Rating: 4.0 (12 reviews)

10 - 11 October, 2022

This MasterClass shall describe the general increase in combination products and in particular products now regulated by both drug and medical device regulation.

Implementation of ISO 13485 MasterClass shall describe the general increase in combination products and in particular products now regulated by both drug and medical device regulation it is important to decide if, when and how ISO13485 should be implemented within your organisation.

10 - 11 October, 2022, Virtual

Time Zone: UTC/GMT+1 /CET

GET THE AGENDA NOW

Quality

Registration

Medical device quality system requirements and when they apply to medicinal products.

Implementation

Determining whether to implement ISO13485 in the design of drug.

Design

How ISO13485 helps the design transfer for the drug delivery device.

Standard

How ISO13485 is similar and different to standard drug GMP.

Correlation

Understand the correlation between ISO13485, international regulations and ISO14971

Vigilance

Pharmacovigilance V medical device vigilance.

Trusted by over 17,000 delegates across leading companies

GET THE AGENDA NOW

Pharma Online MasterClass Overview

Overview

This online training shall describe the general increase in combination products and in particular products now regulated by both drug and medical device regulation it is important to decide if, when and how ISO13485 should be implemented within your organisation. Examples include developing a design control process for a drug delivery device or ensuring the supplier of your metered dose inhaler applies the most appropriate manufacturing and quality plans. This could helps you to work out exactly when and how to implement ISO 13485 by considering different case studies and pharmaceutical company quality management systems.

#masterclass #glceurope #pharmaonlinetraining #globalleadingconferences #implementationofisomasterfile

Trainer

James Pink

James Pink has over 25 years experience in medical device safety, regulatory compliance, market access, professional training and auditing. He has over 15,000 hours of auditing against medical device and cyber security requirements in 45 countries. NB Certification decisions, mock audits and due diligence. He taught over 10,000 students in auditing, technical documentation review, quality systems, risk management and product safety. Designed and delivered IRCA lead auditor and University Medtech MSc. He has contributed to several medical devices standards committees including ISO 13485, ISO 14971 and various product-related standards.

GET THE AGENDA NOW

Reasons to attend a masterclass

Practical knowledge

Venture into undiscovered territories and gain inspiration through collaboration

Interactivity

Boost your professional skills by directly engaging with domain experts

World-class trainers

Gain value and learn from the best instructors

Networking

Build a top-notch community and advance your career

Who should attend img RECOMMENDATION

Who should attend?

• Combination product program managers

• Quality systems and compliance managers determining their compliance strategy for a drug-device combination

• DevelopmentEngineers andSupplyChainpersonnelinvolvedinDDCdevelopment or manufacture

Ticket options for you

Full event
pass

Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey

Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi

USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej

Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany

About GLC

Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today it’s an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.

know more >