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2-Day In-Person Workshop (October 28 - October 29, 2015)
Basic Medical Device Quality and Regulatory Compliance + Auditing This 2-day hands-on interactive workshop will help you understand the basics of medical device quality, quality systems, and regulatory compliance. You will also learn the purpose and scope of the three types of medical device audits, when to initiate and not to initiate these audits, best audit practices, the similarities and differences between FDA and EU Notified Body audit requirements, and what is expected when an external auditing body performs an investigation, inspection, or audit of your quality system. Most industry personnel are overwhelmed by national and international quality system laws, directives, regulations, standards, and guidance documents. As such, they believe if they obtain quality system certification from a European Notified Body that they will automatically pass an FDA audit. However, this is not the case, especially in the areas of medical device quality systems, and regulatory compliance. FDA warning letter after Warning Letter prove otherwise…True that Europe’s quality management system standard (ISO 13485) and U.S.A’s quality system regulation (21 CFR Part 820) are very similar in nature. However, your quality system is viewed totally different by the FDA than by the European Union. Not only is it required under law to have quality system procedures and records, however both the FDA and Notified Bodies require you to also have a sound regulatory compliance system that links against a sound quality system. If top management do not initiate an effective quality and regulatory system, not only may regulatory compliance sanctions against the company occur, but the company may also loose its competitive advantage, have customer lawsuits, perform unnecessary recalls, and be known as a company with non-quality products and services |
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This workshop is designed to extensively cover the entire gamut of medical device quality and regulatory beginning with basic quality concepts. The workshop will address industry issues arising from the lack of clarity on the meanings of quality, quality systems, regulatory compliance, and auditing and their implementation. Also addressed will be resolution methods for recent medical device Warning letters. This course is designed for novices and advanced personnel alike and benefits those in senior management and others who utilize medical device quality systems for laboratories, clinical trials, contract manufacturing, and other medical device and combination product industries as well as for quality system suppliers, contractors, and consultants engaged in the design, development, and manufacture of medical devices and servicing of quality systems for the medical device and combination product industries.
Participants will review audit and inspection approaches, case studies, FDA 483s, and warning letters so as to enable them to speak the same “language of medical device quality and regulatory compliance” as those of the regulators and thereby significantly reduce risk of audit failures.
This workshop will provide valuable assistance to all medical device companies in developing a sound quality and regulatory system, initiating, handling, monitoring, managing, and maintaining audits, and when to initiate and not initiate audits, The focus will be a basic understanding of quality, quality systems, regulatory compliance, and auditing without confusing everyone with regulatory compliance jargon. The workshop will include the following:
1) The definitions, purpose, and scope of medical device quality systems, regulatory compliance, and auditing;
2) Quality, quality system, and regulatory compliance basics;
3) How regulatory compliance fits into a quality system;
4) Regulatory compliance laws, regulations, directives, standards, and guidance;
5) Medical Device quality system and regulatory compliance organization and roles;
6) Similarities and differences between FDA and EU Notified Body philosophies, quality systems, audits, and enforcement;
7) The difference between medical devices, pharmaceuticals, and biologics;
8) The various types and classifications of FDA and EU medical devices;
9) The three types of medical device audits;
10) When to initiate, handle, monitor, manage, and maintain audits;
11) What to do before, during, and after FDA and EU Notified Body audits;
12) FDA website walk-through;
13) FDA’s Quality System Inspection Technique (QSIT); and
14) FDA Medical Device Regulatory Compliance Nonconformance, 483s, Warning Letters, and Trends.
Participants will review audit and inspection approaches, case studies, FDA 483s, and warning letters so as to enable them to speak the same “language of medical device quality and regulatory compliance” as those of the regulators and thereby significantly reduce risk of audit failures.
This workshop will provide valuable assistance to all medical device companies in developing a sound quality and regulatory system, initiating, handling, monitoring, managing, and maintaining audits, and when to initiate and not initiate audits, The focus will be a basic understanding of quality, quality systems, regulatory compliance, and auditing without confusing everyone with regulatory compliance jargon. The workshop will include the following:
1) The definitions, purpose, and scope of medical device quality systems, regulatory compliance, and auditing;
2) Quality, quality system, and regulatory compliance basics;
3) How regulatory compliance fits into a quality system;
4) Regulatory compliance laws, regulations, directives, standards, and guidance;
5) Medical Device quality system and regulatory compliance organization and roles;
6) Similarities and differences between FDA and EU Notified Body philosophies, quality systems, audits, and enforcement;
7) The difference between medical devices, pharmaceuticals, and biologics;
8) The various types and classifications of FDA and EU medical devices;
9) The three types of medical device audits;
10) When to initiate, handle, monitor, manage, and maintain audits;
11) What to do before, during, and after FDA and EU Notified Body audits;
12) FDA website walk-through;
13) FDA’s Quality System Inspection Technique (QSIT); and
14) FDA Medical Device Regulatory Compliance Nonconformance, 483s, Warning Letters, and Trends.
Who will benefit:
This workshop applies to personnel and companies in the medical device and combination products industries. The employees who will benefit most include:
This workshop applies to personnel and companies in the medical device and combination products industries. The employees who will benefit most include:
- Senior management,
- Regulatory Affairs, Regulatory Compliance, Quality Assurance, and Quality Control personnel
- Quality, Manufacturing, and Design engineers
- Production, facility, and operations personnel, and
- Purchasing, Sales and Marketing personnel.
For additional information on the workshop agenda and logistics, please call +1 877-566-4981 or +1 410-501-5777 or email: [email protected]
