Overview
A reputation for Quality and Compliance can be a huge competitive advantage for medical device companies. When it comes to the health of loved ones, consumers want medical products from companies that they can trust. It takes consistent high-quality results and time to earn that trust. It takes time to build a reputation for quality and compliance. It takes a culture within your company to always deliver excellence. Building a culture of quality does not happen by accident. It requires deliberate management vision, strategy, and tactical execution. A culture of quality can be very powerful for your company to earn the trust of consumers. A culture of excellence and a management philosophy will lead to improved customer satisfaction and long-term business success.
This webinar will help you to imbed a culture of quality throughout your organization. We will discuss concepts for creating a culture of quality and management excellence with your company.
Why Should You Attend
Every organization has stakeholders. Your customers demand safe and effective medical devices. The regulators expect you to follow the regulations for your markets with resulting product quality and compliance. And your business can’t survive without efficient and effective processes to manage scarce resources. This webinar can help you balance and meet all of those expectations. You will learn how to create a culture of quality that can be a competitive advantage.
Learning Objectives
- Warning signals that indicate quality problems within your organization
- Changing your organization form reactive to proactive
- How a culture of quality and compliance can impact your company success
- The risks your company faces from quality and compliance issues
- Creating a culture of quality and compliance at all levels of your organization
Webinar Takeaway
This 90-minute webinar will cover:
- FDA and NB expectations for Quality Systems
- Lessons Learned from 483s and warning letters
- How culture can impact quality and compliance risk
- Management commitment and responsibility
- Maturity levels to understand your culture of quality
- Roles and responsibilities
- The case for quality
- Stages of quality and compliance culture
- Tools and techniques for improvement
- Best Practices
Who Will Benefit
- Quality Systems Specialists
- Quality and Compliance Specialists
- Internal Auditors and Managers
- Training Specialists
- CAPA Specialists
- Management Representatives
- Quality and Compliance Managers/Leaders
- Quality/Compliance managers or directors for Medical Device companies
- General Managers wanting to learn how to understand Quality System requirements
Faculty Susanne Manz
Consultant | Educator | Author
Baltimore City County, Maryland, United States
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has worked at industry leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a CQA (Certified Quality Auditor) from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.
Our Participants Testimonial
The presentation by Carolyn Troiana today was fantastic, both I and the QA Manager (Aaron Neighbour) loved it and had extensive conversation afterward about it. ( FDA Compliance and Mobile Applications Webinar )
Robert Friedland ( IT Manager) NUTEK BRAVO, LLC.
Thank you for providing the information in such detail. It was helpful to gain the perspective of somebody that has implemented these regulations in a working lab. Virtual Seminar on ( Training on Life cycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines )
Tracey Kessler ( Director of R&D) CEL-SCI Corporation
I felt the seminar was very helpful and provided good insight for DataIntegrity and what the FDA is looking for per the regulations. ( Current Regulatory Thinking on Data Integrity 2 Days Virtual Seminar )
Margaret A. Clifton ( Manager, Quality Systems) CSL Plasma
The presenters subject matter knowledge is extensive which enables information to be shared in detail. (Training Attended on Risk Based Verification and Validation Planning to Meed US FDA and ISO 13485 Requirements )
Stuart Chisholm (Sr. Principal Device Engineer) Teva Pharmaceuticals
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About World Compliance Seminars (WCS)
World Compliance Seminars (WCS) is one stop solution for all your pharmaceutical, biotechnology and medical device certification program needs. The pharmaceutical and medical device training requirements are set forth by the FDA (Food and Drug Administration) and other major regulatory bodies like NIH, EMA, as well as numerous European based national regulatory bodies.
These requirements are important to the training of pharmaceutical reps who are responsible for the education, professional development, and on-the-job training. The training is broken down into different sections to cover a wide variety of topics, including pharmaceutical formulation, pharmaceutical transfer processes , GLP, GMP, Clinical Compliance, Process Validation, Global Regulatory Affairs, Document Management,GMP (Good manufacturing practice) QSR and CMC and many more.
The pharmaceutical and medical device requirements that the FDA has set forth are designed to protect the public's health and safety. Pharmaceutical reps must adhere to all of the regulations and education courses provided by the FDA in order to be considered one of the best in their field. They also must complete ongoing educational opportunities and maintenance programs in order to maintain relevance and career enhancement.