Combination products represent a noteworthy prospect for the user with regular and long-term dosing requirements. The availability of commercialized devices with automated functions is increasing and this may benefit and reduce the burden on the user and on healthcare systems.
This webcast will walk you through the regulatory approach and the new regulations applied for combination products. It will also cover the elements of the current Good Manufacturing Practices (cGMP) requirements that are applicable for drug-device single entities and co-packaged combo products.
This webcast will cover:
- cGMP requirements for the classification of drug-device combination products
- The common pitfalls drug companies face when they pursue the development of a combination product
- The best approach for the development of drug and device products
- Risk management and control strategies
- The new regulations applied for combination products
- Labelling requirements
Upon conclusion of the program, attendees will understand:
- cGMP regulatory framework
- A regulatory approach to the classification of combination products
- A device QS regulation and drug cGMP based streamlined approach
Who Should Attend?
- Quality professionals
- Regulatory professionals
- Compliance managers
- Risk management professionals
Audience Learning Level
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Senior Quality Specialist, Qualio
Sumatha Kondabolu has more than 18 years of quality and regulatory experience in the medical device and pharmaceutical industries. She has spent time with start-up, mid-size and multinational companies. Kondabolu has experience in implementing quality management systems—requirements for regulatory purposes US FDA QSR, Canada’s Medical Devices Regulations, NIOSH, and specific requirements of the medical device regulatory authorities participating in the MDSAP program, COFEPRIS, and EU MDR. She holds a master’s in chemistry, and an advanced certificate in quality assurance management, along with auditor certifications for ISO 13485, ISO 17025, and ISO 9001.
Director of Quality, Qualio
Kelly brings over 20 years of experience in both the pharmaceutical and medical device industries to the world of small start-ups and scalable quality system implementations. Having been an implementer, administrator and user of many different eQMS tools on the market, she has built several quality systems and is an advisor to over 30 Medical Device and Pharma companies. She is currently the Director of Quality at Qualio, helping customers and the company adhere to the evolving regulatory landscape.