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Executive Overview (Medical Device & Pharmaceutical)
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Course
0701
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0.5
Day
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.4
CEU
Call for pricing at your location.
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Why SAI Global?
- Our courses teach real-world business objectives in an
interactive learning environment.
- Our instructors have an average of 20 years industry experience.
- We offer excellent customer service.
- We have maintained a 98.9% approval rating among more than 200,000
training participants.
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If you have questions about this course,
submit a
Course Information
Request
or call us at 1-800-374-3818.
To learn about the savings and instructional benefits of training five or more participants
at your location, submit an
On-Site Quote Request
or call us at 1-800-374-3818.
To learn how you can save 10% - 30% on course registrations with SAI Global as your preferred training provider, submit a
Customer Rewards Request or call us at 1-800-374-3818.
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Course Objectives
To provide a high level business focused review of the domestic and international regulations faced my medical device, pharmaceutical and biotech industries; to explain the relationship between ISO 9001 and ISO 13485.
Course Agenda
This in-house only course is designed for senior-level management and key implementation personnel. The session will overview applicable requirements (ISO 13485, ISO 9001, FDA regulations, International regulations, CE Mark, etc.) plus how they apply to and impact your business. Additionally the session will provide guidance on how to maintain compliance while achieving business improvement and performance goals.
Course Benefits
- High Level Requirements
- Review ISO 13485, ISO 9001, FDA, cGMPs, International regulations, etc.
- Business issues:
- Time to market
- Understanding user needs
- Customer satisfaction
- Liabilities and Concerns
- Resource requirements
- Recognize the importance of management involvement and commitment
- Discover how to use ISO 9000/ ISO 13485 as a tool for improvement
- Consider the cost to implement (people, time, money)
- Understand the basics of the auditing process
- Recognize customer demands and estimate future inquiries
- Registrars/Notified Bodies
Who Should Attend
- Presidents
- Vice-Presidents
- General Managers
- Business Unit Managers
- Officers
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