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

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    Website https://compliancetrainings.com/SiteEngine/ProductDetailView.aspx?id=MD1092 | Want to Edit it Edit Freely

    Category Medical Devices

    Deadline: October 24, 2014 | Date: October 24, 2014

    Venue/Country: Online, Canada

    Updated: 2014-10-06 22:13:37 (GMT+9)

    Call For Papers - CFP

    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


    Keywords: Accepted papers list. Acceptance Rate. EI Compendex. Engineering Index. ISTP index. ISI index. Impact Factor.
    Disclaimer: ourGlocal is an open academical resource system, which anyone can edit or update. Usually, journal information updated by us, journal managers or others. So the information is old or wrong now. Specially, impact factor is changing every year. Even it was correct when updated, it may have been changed now. So please go to Thomson Reuters to confirm latest value about Journal impact factor.