2014 - Webinar on Major Considerations for Expanding your Quality System requirements (QSR) from Medical Devices to Combination Devices

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 experience and proven practices and hence several practical tips will be useful even to established combination device manufacturers.
Areas Covered in the Session :
Brief introduction to common combination devices, types and benefits
How medical device manufacturers can have a competitive advantage, with established QSR
Implementing Quality System Regulation
21 CFR Part 820/ISO 13485 Vs 21 CFR Part 210/211 & 21 CFR Part 4 for Devices, effective July 2013
FDA’s Final rule for clarification of cGMP requirements for combination products and its implications
How to apply the right requirements to remain compliant
Why and how to sufficiently anticipate and address the quality and regulatory challenges
Considerations while expanding your QSR from Medical Devices to Combination Devices
Role of Primary Mode of Action (PMOS)
Implementation of Unique Pharma Provisions of 21 CFR 211
How to manage Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs)
Submission Requirements for approval and clearance
Post market vigilance differences
How to sustain the growth to your Quality System in the long run
Who Will Benefit:
A must attend webinar for all Managers, Supervisors, Directors, and Vice-Presidents of:
Quality Management Teams
Reasearch & Development Teams
Design Engineering Teams
Quality Assurance
Manufacturing Engineering Teams
Operations Team
Document Control and Regulatory Departments
Regulatory Professionals in Pharma and Medical Device manufacturing and marketing
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