Differences in regulatory requirements between Medical Devices and Pharmaceutical products poses unique challenges to companies that want to manufacture devices that contain drugs and biological products (aka Combination Devices). Large and small medical device companies who want to embark into this new journey by adding a coating of a slow eluting drug product to their medical devices face challenges that range from facility design, changes in testing requirements to evaluation of major considerations in navigating their regulatory path to fulfilling the quality system requirements (QSR) in the ever changing, fast growing, complex arena of medical devices and pharmaceutical GMP considerations under one QSR umbrella.
This webinar presents important facts to simplify the planning and execution phase in your journey towards becoming a combination device manufacturer by incorporating the essential quality system requirements in your company. The experience shared at this webinar is based on experience and proven practices and hence several practical tips will be useful even to established combination device manufacturers.
Areas Covered in the Session :
Brief introduction to common combination devices, types and benefits
How medical device manufacturers can have a competitive advantage, with established QSR
Implementing Quality System Regulation
21 CFR Part 820/ISO 13485 Vs 21 CFR Part 210/211 & 21 CFR Part 4 for Devices, effective July 2013
FDA’s Final rule for clarification of cGMP requirements for combination products and its implications
How to apply the right requirements to remain compliant
Why and how to sufficiently anticipate and address the quality and regulatory challenges
Considerations while expanding your QSR from Medical Devices to Combination Devices
Role of Primary Mode of Action (PMOS)
Implementation of Unique Pharma Provisions of 21 CFR 211
How to manage Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs)
Submission Requirements for approval and clearance
Post market vigilance differences
How to sustain the growth to your Quality System in the long run
Who Will Benefit:
A must attend webinar for all Managers, Supervisors, Directors, and Vice-Presidents of:
Quality Management Teams
Reasearch & Development Teams
Design Engineering Teams
Quality Assurance
Manufacturing Engineering Teams
Operations Team
Document Control and Regulatory Departments
Regulatory Professionals in Pharma and Medical Device manufacturing and marketing
Meena Chettiar is a certified instructor for ASQ learning institute for CBA and an adjunct instructor for Medical Technology Quality graduate program for St. Cloud State University in Minnesota. Meena is a coauthor of the CBA (Certified Biomedical Auditor) Primer for the Quality Council of Indiana.
She is Senior Supplier Quality Engineer at Covidien in Plymouth, Minnesota, USA. Prior to this position, Meena served as a Senior Quality Associate (Lead Auditor and CAPA Coordinator) at Baxter Bio Surgery in St. Paul, MN. Meena worked as a Senior Quality Manager at Teva Pharmaceuticals for over 10 years and as Instrumentation lab supervisor at Land O' Lakes. Meena has also worked for Agriculture and Health Canada in several technical capacities for about 10 years. Meena made the transition to the medical device industry after completing a MS in Regulatory Affairs for Medical Devices through St. Cloud State University in 2010.
Meena has played a key role in quality system implementations in the food, pharma, and medical device industries. Meena has participated as the lead supplier/internal/GMP auditor in several compliance audits in the US and abroad. She has a strong auditing background in the pharmaceutical and medical device auditing. Meena is a senior member of ASQ (American Society for Quality) and is ASQ certified CQA (Certified Quality Auditor), CBA (Certified Biomedical Auditor), CQIA (Certified Quality Improvement Associate), and CMQ/OE (Certified Manager of Quality/Organizational Excellence). She has served as an instructor for these ASQ certification classes since 2006.
Ms. Chettiar received her M.S. in Chemical engineering from University of British Columbia and her B.S. and M.S in Applied 91AV from the University of Madras, India. Meena is very happy to present webinars for Compliance Trainings and continue to contribute towards quality and global regulatory compliance for regulated industries.
Price Tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
This webinar presents important facts to simplify the planning and execution phase in your journey towards becoming a combination device manufacturer by incorporating the essential quality system requirements in your company. The experience shared at this webinar is based on experience and proven practices and hence several practical tips will be useful even to established combination device manufacturers.
Areas Covered in the Session :
Brief introduction to common combination devices, types and benefits
How medical device manufacturers can have a competitive advantage, with established QSR
Implementing Quality System Regulation
21 CFR Part 820/ISO 13485 Vs 21 CFR Part 210/211 & 21 CFR Part 4 for Devices, effective July 2013
FDA’s Final rule for clarification of cGMP requirements for combination products and its implications
How to apply the right requirements to remain compliant
Why and how to sufficiently anticipate and address the quality and regulatory challenges
Considerations while expanding your QSR from Medical Devices to Combination Devices
Role of Primary Mode of Action (PMOS)
Implementation of Unique Pharma Provisions of 21 CFR 211
How to manage Critical Quality Attributes (CQAs) and Critical Process Parameters (CPPs)
Submission Requirements for approval and clearance
Post market vigilance differences
How to sustain the growth to your Quality System in the long run
Who Will Benefit:
A must attend webinar for all Managers, Supervisors, Directors, and Vice-Presidents of:
Quality Management Teams
Reasearch & Development Teams
Design Engineering Teams
Quality Assurance
Manufacturing Engineering Teams
Operations Team
Document Control and Regulatory Departments
Regulatory Professionals in Pharma and Medical Device manufacturing and marketing
Meena Chettiar is a certified instructor for ASQ learning institute for CBA and an adjunct instructor for Medical Technology Quality graduate program for St. Cloud State University in Minnesota. Meena is a coauthor of the CBA (Certified Biomedical Auditor) Primer for the Quality Council of Indiana.
She is Senior Supplier Quality Engineer at Covidien in Plymouth, Minnesota, USA. Prior to this position, Meena served as a Senior Quality Associate (Lead Auditor and CAPA Coordinator) at Baxter Bio Surgery in St. Paul, MN. Meena worked as a Senior Quality Manager at Teva Pharmaceuticals for over 10 years and as Instrumentation lab supervisor at Land O' Lakes. Meena has also worked for Agriculture and Health Canada in several technical capacities for about 10 years. Meena made the transition to the medical device industry after completing a MS in Regulatory Affairs for Medical Devices through St. Cloud State University in 2010.
Meena has played a key role in quality system implementations in the food, pharma, and medical device industries. Meena has participated as the lead supplier/internal/GMP auditor in several compliance audits in the US and abroad. She has a strong auditing background in the pharmaceutical and medical device auditing. Meena is a senior member of ASQ (American Society for Quality) and is ASQ certified CQA (Certified Quality Auditor), CBA (Certified Biomedical Auditor), CQIA (Certified Quality Improvement Associate), and CMQ/OE (Certified Manager of Quality/Organizational Excellence). She has served as an instructor for these ASQ certification classes since 2006.
Ms. Chettiar received her M.S. in Chemical engineering from University of British Columbia and her B.S. and M.S in Applied 91AV from the University of Madras, India. Meena is very happy to present webinars for Compliance Trainings and continue to contribute towards quality and global regulatory compliance for regulated industries.
Price Tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
