Webinar on Extending Your Quality System from Medical Devices to Manufacturing of Combination Products, Your Unique Challenges and How to Overcome them

Description : 

This webinar presents important facts to simplify the planning and execution phase in your journey towards becoming a combination device manufacturer by incorporating the essential quality system requirements in your company. The experience shared at this webinar is based on proven successful practices and hence practical tips that will be useful to employees of established and emerging combination device manufacturers will be presented to you.

Areas Covered in the Session :

Brief introduction to common combination devices, why combination devices to advance patient care and provide competitive market advantage?

Types of combination products and which QSR applies to which combination/primary mode of action.

Current Guidance Documents.

Why a one size fits all approach to QSR just will not work for combination devices?

Quality System Regulation, 21 CFR Part 820/ ISO 13485 Vs 21 CFR Part 210/21, 21 CFR Part 4

Guidance for Industry and FDA staff on GMP Requirements for Combination products released in January 2015

Unique challenges and an insight into how you can overcome them

Implications of FDA’s Final rule for clarification of cGMP requirements for combination products

Why and how can medical device manufacturers broaden their in house and consulting expertise

How to sufficiently anticipate and address the challenges in quality and regulatory issues that must be considered while expanding your Quality System Requirements (QSR) from Medical Devices to Combination Devices

Role of primary mode of action (PMOS) of your device and submit paper work to the respective EU and US FDA regulatory body.

Implementation of unique pharma provisions of 21 CFR 211 such as

Expiration dating

Out of specification

Stability testing

UDI Labelling Requirements

MDR for complaints

Sterilization

Clean room environment

Managing critical quality attributes (CQAs) and critical process parameters (CPPs), clinical studies, submission requirements for approval and clearance and post market vigilance differences.

Who Will Benefit:

A must attend webinar for Managers, Supervisors, Leads, Specialists, Engineers and Groups in Department of:

Research & Development

Manufacturing and Process Engineering

Design Assurance

Quality Assurance

Quality Control

Design Engineering

Operations

Document Control

Regulatory Affairs

Price tags:

Live

Single Live : For One Participant

$ 249

Corporate Live : For Max. 10 Participants

$ 899

Recording

Single REC : For One Participant - Unlimited Access for 6 Months

$ 299

For more information and enquiries contact us at

Compliance Trainings

5939 Candlebrook Ct, Mississauga, ON L5V 2V5, Canada 
Customer Support : #416-915-4458 
Email : support@compliancetrainings.com

For more information about this event please visit

https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1094