As the global distributers and manufacturers of Medical devices and pharmaceuticals expand their quality management system (QMS) to cover the pharmaceutical and medical device requirements under one umbrella, the need to understand the quality system requirements that are unique to each industry becomes very crucial. In this webinar, the presenter with 1st hand proficiency in setting up and speaking the quality language of medical device and the pharma world will provide unique tips for those companies that are making the transition from medical device to pharmaceuticals and vice versa or in to the fast growing world of drug coated medical devices also known as Combination Products.

Course Objectives:

• What are the features of QMS that are common to the pharma and medical device QMS?
• Which features are unique to the world of medical devices for globally marketed products?
• Which features are unique to the pharmaceutical/drug world?
• What is required to fulfill the cGMP needs of the fast growing Combination products?
• How should the gap analysis be performed for a seamless transition?
• Planning and implementation of your QMS under one umbrella to successfully withstand scrutiny by worldwide regulatory bodies and for your overall business risk management

Why Should You Attend:

Professionals are often thrown into the challenge of adapting and expanding their quality system requirements in order to accommodate their expanding business and customer needs. This webinar will help you overcome the challenge by educating you on the QMS needs that are common and those that are unique to Pharma and Medical device world so you can focus on areas that need to be nurtured as you make this important transition from 21 CFR 210/211 to 21 CFR 820 and vice versa to fulfill FDA regulatory needs for your effective quality system that will be housed under one umbrella.

Course Outline:

• QMS requirements for pharma world for products distributed globally
• QMS requirements for medical devices distributed globally including ISO 13485 requirements
• QMS requirements for combination devices
• Categorization and prioritization of your unique QMS needs for successful integration
• What are the consequences of not housing your QMS under one umbrella?
• What are the practical benefits of effectively managing your Quality system under one umbrella?
• How can implementation of this knowledge provide you a competitive advantage over similar players in your business?

What You Get:

• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points

Who Will Benefit:

• Quality Managers/ Directors
• QA/QC and Regulatory Professionals in pharmaceutical and medical device industries
• Quality Engineers and Quality Auditors
• Supply Chain Managers/Auditors
• Management professionals in FDA Regulated industries
• R&D and design engineers
• Global professionals looking for employment in medical device and pharmaceutical industries