MDSAP Audits – All You Need to Know

After the final FDA approval and initiation of marketing of your medical devices, regulating bodies such as US FDA and other regulatory bodies send their inspectors on a periodic basis to device manufacturing facilities. Now, the new MDSAP, Medical Device Single Audit Program can reduce the frequency and length of these audits. This important and timely webinar will discuss the key preparation steps for MDSAP of your medical device manufacturing quality system.

Why You Should Attend:

Large and small medical device companies will have additional challenge in preparing for and dealing with audits under the current Tsunami of escalating medical device regulatory and global auditing requirements. Quality and Manufacturing personnel in charge of creating and maintaining your quality management system for all of the medical devices manufactured at your facility should be familiar with MDSAP auditing expectations. The fact is: that global regulatory expectations for medical devices are escalating. The bar has been raised a lot for MDSAP after ISO 13485: 2016 and introduction of the harmonization efforts by IMDRF (International Medical Device Regulatory Forum).

Areas Covered in the Session :

• MDSAP Audit requirements as per USFDA, Health Canada, TGA, ANVISA, Japan’s PMDA
• MDSAP quality and regulatory requirements for:
  • Management Controls
  • Product design Controls
  • Production and Process Controls
  • CAPA Subsystem
  • Sterilization Controls
• GMP regulations to withstand a solid MDSAP scrutiny
• Simplifying audit planning and execution
• Specific areas auditors will examine and questions they will ask
• How MDSAP compares to an ISO 13485: 2016, Canada’s CMDCAS and the US FDA’s 21 CFR 820 inspections
• The MDSAP grading system and how nonconformance issues can be escalated
• How risk assessment will play a major part in audits of this risk averse industry
• How each of the five countries will implement MDSAP
• The outlook for EU participation
• Requirements unique to each participating country

Who Should Attend:

• Research and Development Departments
• Quality Assurance Departments
• Quality Control Departments
• Regulatory Affairs Departments
• Manufacturing Departments
• Auditors, Audit Facilitators and Inspection Personnel
• Engineering Departments
• Operations Departments
• Design Assurance Teams
• Document Control Professionals

Course Director: MEENA CHETTIAR 

Meena Chettiar currently works as a Quality and regulatory Manager at ProMed Pharma in Minneapolis. Meena has worked as a Senior Supplier quality engineer at Covidien, Senior Quality Associate (Lead Auditor and CAPA Coordinator) at Baxter Bio Surgery in St. Paul, MN. Meena worked as a Senior Quality Control 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 before immigrating to the United States. 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 been serving as an instructor for these ASQ certification classes since 2006 and has conducted quality and medical device related training classes in her current position at Baxter. Meena is a coauthor of the CBA (Certified Biomedical Auditor) primer for the Quality Council of Indiana. She is currently an adjunct instructor for the medical technology quality program at St. Cloud State University in Minnesota. Ms. Chettiar received her M.S Regulatory Affairs and Services for Medical Devices from St. Cloud State, Minnesota, M.S. in Chemical engineering from University of British Columbia and her B.S. and M.S in Applied Chemistry from the University of Madras, India. Meena is happy to teach webinars for the Compliance Trainings and continue to contribute towards quality and regulatory compliance.