Quality System Training

Our FDA inspection readiness curriculum includes individualized presentations and case studies intended to provide executives, managers and manufacturing employees with the right level of regulatory knowledge and an understanding of what to expect during an inspection.

We feature role-playing exercises to help personnel prepare for effective FDA interaction. This may include conducting mock FDA interview sessions with key personnel to give them an opportunity to practice presenting their QMS processes or documents such as CAPAs, recall files, validations, etc.

These mock FDA interview sessions allow an opportunity for coaching and optimizing content delivery, with real-time feedback on:

• Body Language
• Effective Communication
• Presentation

QualityHub offers a variety of courses in quality management systems (QMS) and good manufacturing practices (GMP). These range from an overview for those needing a basic understanding of requirements to advanced training workshops for quality and regulatory professionals.

Our QMS/GMP training provides an understanding of QMS/GMP regulation and practical guidance on implementation within a regulated environment. We can tailor this training to address:

• Medical Device
• Pharmaceutical
• Biologic
• Combination Products

QualityHub’s QMS/GMP training includes case studies and examples to help employees apply learned concepts. Our training focuses on the application of risk-based thinking to the management of quality systems, linkages between sub-systems, and sustainability for compliance. Upon request, we offer post-training testing as evidence of comprehension and training effectiveness.

QualityHub can help your organization understand the latest EU MDR (European Medical Device Regulations) requirements and how these can be harmonized with other global regulatory requirements. Our training focuses on the differences (sometimes subtle) between US regulatory requirements for medical devices and the EU requirements as well as practical application. We can customize this training for concurrent delivery with training on US FDA requirements for medical devices.

This training covers the FDA’s Quality System Inspection Technique (QSIT) for medical devices. Using much of the same content FDA uses to train their investigators, this course covers the basic aspects of QSIT, with a focus on the four key systems:

1. Management Controls
2. Design Controls
3. CAPA
4. Production & Process Controls

The training addresses linkages between subsystems as well as methods for addressing all areas of the quality management system through the four main subsystems. QSIT training helps employees understand FDA expectations during a typical medical device inspection and includes information on inspection/auditing techniques that would be specifically helpful for those with responsibilities for internal and supplier auditing.

The management of complaints and the submission of adverse event reports in accordance with applicable regulatory requirements in a key aspect of post-market surveillance and is an important part of risk management.

Our complaint-handling training courses address:

• Intake
• Triage
• Investigation
• Statistical trend analysis of data
• Escalation to CAPA
• MDR/Adverse Event reporting requirements

This training can be customized for medical device, pharmaceutical, biologic, or combination products, and ensures all personnel understands what regulators expect to see in their review of complaint records.

This training covers the requirements for Medical Device Risk Management in accordance with ISO 14971. The course covers the tools and techniques for:

• Properly Planning Risk Management
• Identifying Hazards and Hazardous Situations
• Performing Risk Assessments and Risk Analysis
• Risk Mitigation
• Benefit/Risk Review
• Post-Commercial Risk Management

This comprehensive course addresses risk management across the product lifecycle and includes a discussion of product risk, process risk and usability risk. This training is appropriate for both medical device companies and manufacturers of combination products with a medical device constituent.

This training covers the technical requirements for design controls for medical devices as required by the FDA in 21 CFR 820.30. The course covers the tools, techniques and requirements for applying design controls in product development and post-commercial product design changes.

It addresses the application of risk management in product design and development, as well as the fundamental concepts of human factors in design. This training is appropriate for both medical device companies and manufacturers of combination products with a medical device constituent.

QualityHub’s process validation training courses are designed to provide instruction on the development, validation and control of manufacturing and testing processes.

Content can be customized for medical devices, pharmaceuticals, or combination products. The training will emphasize compliance with FDA regulatory requirements, ISO requirements and applicable standards/guidelines (e.g., GHTF/IMDRF or ICH).

This course emphasizes the development of appropriate documentation to support validation and includes an overview of basic statistical techniques for process validation. Attendees will gain an understanding of current industry best practices and will learn how risk management is applied to manufacturing process development, validation and process control.

Our CAPA training covers the FDA and ISO requirements for Corrective and Preventive Action (CAPA), addressing escalation to CAPA from feeder systems, writing effective problem statements, CAPA investigations, development and implementation of CAPA plans, and techniques for verifying effectiveness. The training includes CAPA case studies that can be customized based on the client’s own CAPA examples.

Note: This training is often combined with Root Cause Analysis training.

This course provides tools and techniques for performing and documenting Investigations for both pharmaceuticals, medical devices, biologics, and combination products.

Attendees will gain an understanding of the differences between an evaluation and a root-cause investigation and will learn when a root-cause investigation is necessary. This training focuses on common techniques for determining root cause and best practices in documenting investigations with appropriate objective evidence to support investigation conclusions.

This course provides attendees with knowledge that enables them to apply regulatory requirements to their unique products and processes that they audit. The course can be customized for medical device, pharmaceutical, biologic, or combination products.

The curriculum includes:

• Development of effective audit plans,
• Techniques for auditing different types of records that are maintained under GMP
• Guidelines for managing and communicating during the audit,
• Requirements for reporting observations (non-conformances) and handling the auditee's response

Note: This training may be combined with QSIT training and/or quality management system training.

Manufacturers of combination products must understand the requirements of 21 CFR Part 4 and how to bridge and implement requirements to ensure full coverage of the FDA’s regulatory requirements for combination products. This training is customized based on the client’s primary role as either a device or drug manufacturer and addresses the bridging requirements that would be applicable to their business type.

This training is essential for teaching employees the importance of maintaining objective evidence to demonstrate the suitability and effectiveness of the company’s quality management system. This training discusses what constitutes “objective evidence,” the importance of records and documentation, good documentation practices and the type of objective evidence (OE) the FDA is expecting to see during inspections.