COMPLIANCE TRAINING

​This concise, practical course provides medical device manufacturers and quality professionals with a comprehensive guide to implementing the FDA's new Quality Management System Regulation (QMSR), which harmonizes the legacy Quality System Regulation (QSR, 21 CFR Part 820) with ISO 13485:2016. As the QMSR takes effect on February 2, 2026, this training equips participants with the knowledge and tools to assess gaps, update processes, and ensure compliance in a streamlined manner. Through real-world examples, case studies, and actionable checklists, attendees will learn how to integrate risk-based approaches, enhance management responsibilities, and align with international standards while minimizing disruption to operations. Ideal for organizations preparing for audits or transitioning their quality systems, this course emphasizes practical implementation strategies to achieve regulatory alignment and improve overall quality performance.

 1-day intensive training program on Corrective and Preventive Action (CAPA) systems, focusing on methodologies to identify, investigate, and resolve quality issues in regulated industries like medical devices and pharmaceuticals, emphasizing a structured approach to prevent recurrence.
 

This interactive half-day training provides a comprehensive introduction to Good Clinical Practice (GCP) inspection readiness, emphasizing compliance with International Council for Harmonisation (ICH) standards. Participants will gain practical insights into preparing for and managing regulatory inspections from authorities like the FDA, EMA, or MHRA. Through case studies, group discussions, and real-world examples, the course equips attendees with strategies to identify risks, maintain documentation, and respond effectively during audits, ensuring trial integrity and patient safety in a rapidly evolving regulatory landscape.
 

​This compact 2-hour training delivers core strategies for FDA and EU inspection readiness, aligning with GMP, GCP, and pharmacovigilance standards. Through targeted discussions, real-world examples, and interactive elements, participants will learn to prepare effectively, manage audits, and address findings from regulators like the FDA and EMA. The session emphasizes risk mitigation, data integrity, and building a compliance mindset to navigate global inspections with confidence.
 

This training provides an overview of the FDA's Current Good Manufacturing Practice (cGMP) requirements for dietary supplements as outlined in 21 CFR Part 111. Participants will gain an understanding of the regulatory framework governing dietary supplement manufacturing, packaging, labeling, holding, and quality control operations. The session covers key GMP requirements, quality systems, documentation practices, personnel responsibilities, and common FDA inspection findings. Attendees will leave with a foundational understanding of compliance expectations and best practices for maintaining product quality and regulatory compliance.

This intensive three-day training provides a practical, hands-on approach to implementing and maintaining compliance with FDA Current Good Manufacturing Practice (cGMP) requirements for Dietary Supplements under 21 CFR Part 111. Participants will move beyond regulatory theory to learn how to establish, operate, assess, and improve GMP systems within dietary supplement manufacturing, packaging, labeling, testing, and distribution operations.

This 3-hour training course provides a practical overview of FDA labeling requirements for dietary supplements, helping participants understand how to create and maintain compliant product labels that meet regulatory standards and support lawful marketing practices. Participants will learn the key provisions of the Dietary Supplement Health and Education Act (DSHEA), FDA labeling regulations, and the required elements of dietary supplement labels, including the Principal Display Panel, Supplement Facts Panel, ingredient declarations, claims, and disclaimers.

This one-day training course provides participants with a comprehensive overview of the requirements of ISO 45001:2018, the international standard for Occupational Health and Safety Management Systems (OH&SMS). Designed in accordance with TPECS competency-based training principles, the course introduces the structure, key concepts, and specific requirements of the standard, enabling participants to understand how an effective OH&SMS can help organizations prevent work-related injuries and ill health, fulfill compliance obligations, and continually improve occupational health and safety performance.

This two-hour training course provides participants with an overview of regulatory and quality requirements for medical device labeling throughout the product lifecycle. The course examines the critical role of labeling in ensuring device safety, effectiveness, traceability, and regulatory compliance across global markets.