MDSAP Audits – All You Need to Know

🎤 Meena Chettiar | 📅 Recording Available | 🕒 75 Minutes

Description:

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