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ComplianceOnline, Online Event
2013-02-12
Why Should You Attend: This webinar will provide valuable assistance to all medical device companies in preparing for a CMDCAS upgrade. The focus will be upon creating an outline of the tasks that need to be completed—without confusing everyone with regulatory jargon.
This 60-minute session will will help you understand the process for upgrading an existing Quality Management System from an ISO 13485:2003 certificate to ISO 13485:2003 with CMDCAS. This is a prerequisite for obtaining a Canadian Medical Device License. You will learn how to budget resources (time & money), which guidance documents you will need, best practices for scheduling your upgrade audit, which procedural changes your company needs to make, what additional internal auditing is expected, and how to make sure that your registrar is recognized by Health Canada. Areas Covered in the Webinar: The webinar will include the following critical information you will need: - Which registrar is no longer able to issue CMDCAS certificates.
- Where to find the list of 16 registrars that are recognized by Health Canada.
- How to download your own audit checklist for Canadian Medical Device Regulations (CMDR)
- Weaknesses with the audit checklist and how to fix it.
- The easiest way to determine what is new in the latest update to the CMDR (September 19, 2012)
- Best practices and common mistakes in writing procedures specific to the CMDR.
- The most common nonconformities issued by registrars.
- How long it will take you to achieve CMDCAS certification.
- When you should not bother seeking CMDCAS certification.
Who will benefit: This topic applies to personnel/ companies in the medical device industry. The employees who will benefit most include: - Senior management,
- Regulatory affairs,
- Quality Assurance,
- Documentation,
- Product Management,
- IT/IS,
- Contract manufacturers.
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Organized by:
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Complianceonline |
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Invited Speakers:
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Robert Packard, is a regulatory consultant with 20 years experience in the medical device, pharmaceutical and biotechnology industries. Robert has worked with companies from start-ups to Fortune 100, in the USA, Canada, Mexico and Japan. His specialty is helping companies with regulatory submissions for high-risk medical devices and drug/device combination products. His regulatory expertise includes: CE Marking, Canadian Medical Device Applications, 510(k) Submissions, Post-Marketing Activities, Supplier Quality, CAPA, Risk Management, Auditing and Sterilization Validation. He has held previous positions in R&D, Manufacturing Operations, Quality Assurance and Regulatory Affairs—up to the level of CEO/President. In addition, Robert has extensive technical experience in Lean Manufacturing, Silicone Chemistry, Extrusion, Bioprocess Engineering, and Strategic Planning. He was a 3rd party auditor for one of the largest Notified Bodies, and he conducts training workshops internationally on a variety of regulatory subjects. Robert is a graduate of UConn in Chemical Engineering.
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Deadline for Abstracts:
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2013-02-11
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Registration:
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http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702579?channel=hummolgen
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E-mail:
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referral@complianceonline.com
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