Regulatory Requirements for Personnel Training to Assure QSR and ISO Compliance

Overview:

Ensuring that personnel are properly trained is critical for maintaining compliance with Quality System Regulations (QSR) and ISO standards in regulated industries such as medical devices and pharmaceuticals.

This webinar provides an in-depth overview of the regulatory requirements surrounding employee training and its direct impact on product quality, safety, and compliance. Participants will learn best practices for designing and implementing effective training programs that align with both QSR and ISO guidelines, including documentation requirements, training frequency, and performance evaluation methods.

Real-world examples and case studies will illustrate common challenges and solutions for maintaining training compliance, preparing attendees to streamline their processes and minimize risk during audits. This session is ideal for quality managers, regulatory affairs professionals, and anyone involved in training and compliance functions within their organization.

Why you should Attend:

Attending this webinar is essential for professionals looking to strengthen their understanding of regulatory training requirements and ensure their organization meets QSR and ISO compliance standards. With regulatory agencies placing increased scrutiny on personnel competence and documentation, having a well-structured training program is critical to avoiding costly compliance issues and ensuring operational excellence.

By attending, you will:

• Gain insights into the key regulatory requirements for personnel training under QSR and ISO
• Learn practical strategies for developing effective training programs that meet compliance needs
• Understand how to properly document and evaluate training to satisfy regulatory audits
• Discover real-world solutions to common training challenges that can impact compliance
• Stay ahead of regulatory changes and minimize the risk of non-compliance, safeguarding both your products and your business reputation

This is an invaluable opportunity to enhance your compliance knowledge and make informed, impactful improvements to your organization's training processes.

Areas Covered in the Session:

• Overview of QSR and ISO Training Requirements: A comprehensive look at the personnel training regulations under Quality System Regulations (QSR) and ISO 13485, focusing on how these standards impact compliance and quality management systems
• Designing a Compliant Training Program: Step-by-step guidance on developing an effective and compliant training program, including role-specific training needs, frequency, and customization for different levels of personnel
• Training Documentation and Recordkeeping: Best practices for documenting training activities, maintaining accurate records, and meeting regulatory standards for audit readiness
• Assessing and Verifying Competency: Methods for evaluating training effectiveness, including assessments, ongoing evaluations, and how to ensure employees apply learned skills in practice
• Common Non-Compliance Issues: Analysis of frequent training-related compliance failures found during audits and inspections, and strategies for proactively addressing these issues
• Preparing for Regulatory Audits: Techniques to ensure your training processes and records are ready for inspections by regulatory agencies like the FDA and notified bodies for ISO certification
• Updating Training Programs in Response to Regulatory Changes: How to keep your training program up-to-date with evolving regulations and standards to ensure continuous compliance

Who Will Benefit:

• Training Managers and Coordinators
• Operations
• Manufacturing
• Plant Engineering
• QA/QC Staff
• Process Excellence/Improvement Professionals
• Industrial/Process Engineers
• Compliance officers
• Regulatory/Legislative Affairs Professionals
• General/Corporate Counsel