Training Curriculum

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Regal Intel has provided training in the BioTech industry since 2001. Their training is customized to the client's specific sector, including:

• Pharma
• Biologics
• Medical Device
• Combination Devices
• Companion Diagnostics

• Customized Training: Training is tailored to the client's specific sector.
• Certified Trainers: Trainers are certified.
• Competency Certificates: Attendees receive a competency certificate upon completion.
• Onsite Training: Certified training requires being onsite.
• Cost: Competency training courses are $495 per attendee per day.

• Contact Regal Intel at service@regalintel.com for a custom quotation.

• Abstract: Covers core concepts of the ISO 13485 standard for medical device quality management systems and the FDA's Quality Management System Regulation (QMSR). Explores key clauses, documentation requirements, and implementation basics. Ideal for personnel new to MedTech QMS or needing a comprehensive refresher.
• Estimated Duration: 1-Day
• Primary Focus Area: Medical Device
• Certification Potential: No

• Abstract: Provides detailed guidance on navigating the significant shift from the FDA's traditional Quality System Regulation (QSR - 21 CFR 820) to the new QMSR, emphasizing harmonization with ISO 13485. Covers key changes, gap analysis strategies, and implementation planning. Essential for manufacturers marketing devices in the US.
• Estimated Duration: 1-Day
• Primary Focus Area: Medical Device
• Certification Potential: No

• Abstract: Equips participants with the knowledge and practical skills to plan, conduct, report, and follow up on effective internal QMS audits based on ISO 13485:2016 and referencing ISO 19011 auditing guidelines. Suitable for QA personnel, designated internal auditors, and managers overseeing the audit program.
• Estimated Duration: 2-Day
• Primary Focus Area: Medical Device
• Certification Potential: Leads to Certificate of Completion/Internal Auditor Qualification

• Abstract: Comprehensive, certified course delivering the knowledge and skills required to lead QMS audit teams for audits against ISO 13485. Covers in-depth clause interpretation, audit program management, leading audit teams, conflict resolution, and reporting. Designed for experienced auditors seeking internationally recognized professional certification.
• Estimated Duration: 5-Day
• Primary Focus Area: Medical Device
• Certification Potential: Yes - Leads to Exemplar Global QMS Lead Auditor Certifica

• Abstract: Focuses on the structure and requirements of the MDSAP, covering the specific needs of participating regulatory authorities (e.g., FDA, Health Canada, TGA, ANVISA, MHLW). Explains the audit model, task-based auditing, nonconformity grading, and preparation strategies. Crucial for manufacturers in MDSAP jurisdictions and auditors involved in these audits.
• Estimated Duration: 2-Day
• Primary Focus Area: Medical Device
• Certification Potential: No

• Abstract: Addresses the specific methodologies, enabling technologies, inherent challenges, and best practices for conducting effective and compliant remote QMS audits within the medical device sector. Relevant for internal and external auditors adapting to virtual or hybrid audit environments.
• Estimated Duration: 1-Day
• Primary Focus Area: Medical Device
• Certification Potential: No

• Abstract: Provides a thorough understanding of the complex requirements of the EU MDR. Covers scope and classification, conformity assessment routes, General Safety and Performance Requirements (GSPR), technical documentation structure and content, clinical evaluation, post-market surveillance (PMS), vigilance, and UDI requirements. Essential for RA/QA professionals targeting the EU market.
• Estimated Duration: 2-Day
• Primary Focus Area: Medical Device
• Certification Potential: No

• Abstract: Delves into the specific requirements of the EU IVDR for in vitro diagnostic devices. Covers IVDR classification rules, performance evaluation pathways (including scientific validity, analytical and clinical performance), technical documentation, conformity assessment, PMS, and vigilance reporting. Critical for IVD manufacturers and RA/QA personnel.
• Estimated Duration: 2-Day
• Primary Focus Area: Medical Device (IVD)
• Certification Potential: No

• Abstract: Develops expertise in auditing quality management systems and technical documentation against the stringent requirements of the EU MDR (2017/745). Focuses on Notified Body expectations, assessment of technical documentation, clinical evaluation review, and auditing QMS processes under the regulation. Aimed at experienced auditors, consultants, and internal audit leaders.
• Estimated Duration: 3-Day
• Primary Focus Area: Medical Device
• Certification Potential: Potential for Certification

• Abstract: Explains the US FDA's risk-based device classification system (Class I, II, III) and the associated regulatory controls. Details the primary submission pathways, including Premarket Notification (510(k)), Premarket Approval (PMA), and De Novo classification requests. Foundational for companies developing regulatory strategies for the US market.
• Estimated Duration: 1-Day
• Primary Focus Area: Medical Device
• Certification Potential: No

• Abstract: Comprehensive training on the application of the ISO 14971 standard for risk management throughout the entire medical device lifecycle. Covers risk management planning, hazard identification, risk analysis and evaluation, risk control implementation and verification, residual risk assessment, and post-production monitoring and feedback. Critical for RA/QA, R&D, and Engineering teams.
• Estimated Duration: 2-Day
• Primary Focus Area: Medical Device
• Certification Potential: No

• Abstract: Covers the principles and practical application of design controls as mandated by FDA QSR/QMSR (21 CFR 820.30) and ISO 13485. Details requirements for design and development planning, inputs, outputs, review, verification, validation, transfer, change control, and the Design History File (DHF). Essential for R&D, Engineering, and QA/RA personnel involved in product development.
• Estimated Duration: 2-Day
• Primary Focus Area: Medical Device
• Certification Potential: No

• Abstract: Focuses on establishing and maintaining a compliant and effective Corrective and Preventive Action (CAPA) system. Covers identification of quality data sources, investigation methodologies, robust root cause analysis techniques (e.g., 5 Whys, Fishbone), CAPA plan development, implementation, verification of effectiveness, and documentation. Key for QA/RA and Operations personnel.
• Estimated Duration: 2-Day
• Primary Focus Area: Medical Device
• Certification Potential: No

• Abstract: Provides detailed guidance on planning, conducting, and documenting Clinical Evaluation Reports (CERs) compliant with MEDDEV 2.7/1 rev 4 and EU MDR requirements. Covers defining scope, literature search strategies, data appraisal, analysis of clinical data, demonstrating conformity with GSPRs, and links to Post-Market Clinical Follow-up (PMCF). For RA and Clinical Affairs specialists.
• Estimated Duration: 2-Day
• Primary Focus Area: Medical Device
• Certification Potential: No

• Abstract: Covers the ethical and scientific quality standards outlined in ISO 14155 for designing, conducting, recording, and reporting clinical investigations involving human subjects for medical devices. Addresses investigator responsibilities, sponsor duties, monitoring, and documentation. Vital for Clinical Research staff, Monitors, Investigators, Ethics Committees, and RA/QA.
• Estimated Duration: 1-Day
• Primary Focus Area: Medical Device
• Certification Potential: No

• Abstract: Addresses the specific lifecycle requirements for medical device software development according to the IEC 62304 standard. Covers software development planning, requirements analysis, architectural design, implementation, testing, risk management integration, configuration management, and software maintenance.  For Software Engineers, Testers, and QA/RA involved with SaMD or embedded software.
• Estimated Duration: 2-Day
• Primary Focus Area: Medical Device
• Certification Potential: No

• Abstract: Covers regulatory requirements (FDA QSR/QMSR, ISO 13485) and industry best practices for process validation. Details Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). For Manufacturing/Process Engineers, QA, and Validation specialists.
• Estimated Duration: 2-Day
• Primary Focus Area: Medical Device
• Certification Potential: No

• Abstract: Focuses on establishing and maintaining effective controls over suppliers and subcontractors as required by regulations. Covers supplier evaluation and selection, qualification processes, quality agreements, ongoing monitoring and performance measurement, supplier auditing, and managing supplier nonconformances and changes. Relevant for Purchasing, Supplier Quality Engineers, and QA/RA.
• Estimated Duration: 1-Day
• Primary Focus Area: Medical Device
• Certification Potential: No

• Abstract: Covers the regulatory requirements (FDA 21 CFR 803, 806; EU MDR/IVDR Vigilance) for establishing processes for receiving, reviewing, and evaluating complaints. Details investigation procedures, determining reportability, timelines, and managing corrections and removals, including recall strategy and execution. Essential for Postmarket Surveillance, Complaint Handling Units, and QA/RA.
• Estimated Duration: 1-Day
• Primary Focus Area: Medical Device
• Certification Potential: No

• Abstract: Details the proactive requirements for establishing comprehensive Post-Market Surveillance (PMS) systems under the EU MDR and IVDR. Covers PMS planning, data collection and analysis, PMS reporting (including Periodic Safety Update Reports - PSURs), and developing strategies for Post-Market Clinical Follow-up (PMCF) where required. For RA/QA and dedicated PMS specialists.
• Estimated Duration: 1-Day
• Primary Focus Area: Medical Device
• Certification Potential: No

• Abstract: Addresses the evolving regulatory landscape (FDA pre- and postmarket guidance, EU MDR/IVDR GSPR) and standards (e.g., AAMI TIR57) for managing cybersecurity risks in connected medical devices. Covers threat modeling, vulnerability assessment, security risk analysis, implementation of controls, testing, and lifecycle management. For R&D, Software Engineers, Risk Management specialists, and RA/QA.
• Estimated Duration: 1-Day
• Primary Focus Area: Medical Device
• Certification Potential: No

• Abstract: Covers the principles and application of human factors/usability engineering according to IEC 62366-1 and FDA guidance. Focuses on understanding user needs, user interface design, formative and summative usability testing, use-related risk analysis, and documenting the process in the Usability Engineering File. For R&D, Design Engineers, Human Factors specialists, and RA/QA.
• Estimated Duration: 1-Day
• Primary Focus Area: Medical Device
• Certification Potential: No

• Abstract: Provides a comprehensive overview and comparison of labeling requirements in the key markets of the US (FDA 21 CFR 801) and EU (MDR/IVDR Annex I). Covers general labeling content, use of symbols (ISO 15223-1), UDI requirements, Instructions for Use (IFU) content and format, and considerations for electronic labeling (eIFU). For RA, Labeling specialists, Technical Writers, and Marketing.
• Estimated Duration: 1-Day
• Primary Focus Area: Medical Device
• Certification Potential: No

• Abstract: Equips manufacturers with practical strategies and best practices for preparing for, managing, and responding to regulatory inspections (e.g., FDA QSR/QMSR inspections) and QMS audits by Notified Bodies or MDSAP Auditing Organizations. Essential for Management, QA/RA leadership, and SMEs involved in inspections.
• Estimated Duration: 1-Day
• Primary Focus Area: Medical Device
• Certification Potential: No

• Abstract: Provides a foundational understanding of US FDA Good Manufacturing Practices (GMP) for finished pharmaceuticals as outlined in 21 CFR Parts 210 and 211. Essential for personnel new to pharmaceutical manufacturing, QA, QC, or operations.
• Estimated Duration: 2-Day
• Primary Focus Area: Pharmaceutical
• Certification Potential: No

• Abstract: Focuses on regulatory expectations (FDA OOS Guidance) and best practices for thoroughly investigating Out-of-Specification (OOS) and Out-of-Trend (OOT) laboratory results. Critical for QC/QA laboratory personnel, analysts, supervisors, and managers.
• Estimated Duration: 1-Day
• Primary Focus Area: Pharmaceutical
• Certification Potential: No

• Abstract: Covers the modern lifecycle approach to process validation based on FDA's 2011 guidance and ICH principles. For Process Development scientists, Manufacturing/Process Engineers, Validation specialists, and QA.
• Estimated Duration: 2-Day
• Primary Focus Area: Pharmaceutical
• Certification Potential: No

• Abstract: Delves into the critical aspects of aseptic manufacturing to ensure sterility assurance. Essential for personnel working in or overseeing sterile drug manufacturing operations.
• Estimated Duration: 1-Day
• Primary Focus Area: Pharmaceutical
• Certification Potential: No

• Abstract: Focuses on regulatory expectations (FDA OOS Guidance) and best practices for thoroughly investigating Out-of-Specification (OOS) and Out-of-Trend (OOT) laboratory results. Critical for QC/QA laboratory personnel, analysts, supervisors, and managers.
• Estimated Duration: 1-Day
• Primary Focus Area: Pharmaceutical
• Certification Potential: No

• Abstract: Summarizes the content and format requirements for a Biologics License Application. Outlines the procedural requirements for a BLA submission to the FDA, including key criteria for licensure of biologics.
• Estimated Duration: Varies (Online, self-paced, ~210 minutes learning time)
• Primary Focus Area: Biologics
• Certification Potential: No

• Abstract: Provides an overview of the original Biologics License Application (BLA) process. Topics include BLA review timelines and meetings, filing procedures, regulatory actions, and best practices.
• Estimated Duration: Varies
• Primary Focus Area: Biologics
• Certification Potential: No

• Abstract: Covers Chemistry, Manufacturing, and Controls (CMC) data requirements for filing an NDA/BLA.
• Estimated Duration: Varies
• Primary Focus Area: Biologics
• Certification Potential: No

• Abstract: Provides an overview of the Form FDA 1571 and the IND cover letter. Topics include the critical information that is to be captured in these documents and recommended best practices for completion.
• Estimated Duration: Varies
• Primary Focus Area: Biologics
• Certification Potential: No

• Abstract: Discusses the content and format of an Original IND. Topics include details on the required forms, cross-referencing, CMC content, pharmacology/toxicology content, and clinical content.
• Estimated Duration: Varies
• Primary Focus Area: Biologics
• Certification Potential: No

• Abstract: Discusses the clinical, regulatory, and legal requirements for human tissue products regulated as biologics, including IND requirements and the BLA submission process.
• Estimated Duration: Varies
• Primary Focus Area: Biologics
• Certification Potential: No

• Abstract: Addresses the unique regulatory complexities surrounding combination products (drug-device, biologic-device, drug-biologic). Essential for RA/QA professionals working with these integrated products.
• Estimated Duration: 2-Day
• Primary Focus Area: Combination Product
• Certification Potential: No

• Abstract: Focuses on the practical application of design control principles specifically to combination products. Explores how to effectively integrate device design controls (per 21 CFR 820.30 / ISO 13485) with pharmaceutical or biologic development considerations (QbD) throughout the product lifecycle. For R&D, Engineering, and QA/RA involved in the development of combination products.
• Estimated Duration: 1-Day
• Primary Focus Area: Combination Product
• Certification Potential: No

• Abstract: Explores practical strategies for developing a holistic risk management approach for combination products. Discusses methods for integrating device risk management principles (ISO 14971) with pharmaceutical quality risk management concepts (ICHQ9) to address risks associated with constituent parts and their interactions. For Risk Management specialists, QA/RA, R&D working on combination product.
• Estimated Duration: 1-Day
• Primary Focus Area: Combination Product
• Certification Potential: No

• Abstract: Specifically addresses human factors engineering (HFE) and usability requirements for drug delivery systems, which are often combination products (e.g., auto-injectors, inhalers, pre-filled syringes). For Device Engineers, Human Factors specialists, RA/QA working on delivery systems.
• Estimated Duration: 1-Day
• Primary Focus Area: Combination Product / Drug Delivery
• Certification Potential: No

• Abstract: Tailors root cause analysis techniques to effectively investigate failures, complaints, or deviations specific to combination products. Emphasizes considering potential interactions between the different constituent parts (drug, device, biologic) when determining the true root cause(s). For QA/RA, Complaint Handling, Engineering, and Manufacturing personnel involved with combination products.
• Estimated Duration: 1-Day
• Primary Focus Area: Combination Product
• Certification Potential: No

• Abstract: Covers the critical importance of data integrity (ALCOA+ principles: Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, Available) in regulated GxP environments. For IT, QA, QC, Manufacturing, and system users/administrators.
• Estimated Duration: 1-Day
• Primary Focus Area: Cross-Industry
• Certification Potential: NoPrimary Focus Area: Combination Product
• Certification Potential: No

• Abstract: Focuses on the practical aAbstract: Provides the necessary skills and understanding to conduct effective internal audits against the ISO 9001:2015 quality management system standard. Covers the standard's requirements, audit planning, execution based on ISO 19011, reporting, and follow-up. Relevant for organizations in various industries seeking or maintaining ISO 9001 certification.
• Estimated Duration: 2-Day
• Primary Focus Area: Cross-Industry
• Certification Potential: Leads to Certificate

• Abstract: Comprehensive, certified course designed for professionals seeking to lead QMS audits against ISO 9001. Covers in-depth understanding of the standard, audit management, team leadership, and reporting skills required for certification. Suitable for professionals aiming for lead auditor certification applicable across multiple industry sectors.
• Estimated Duration: 5-Day
• Primary Focus Area: Cross-Industry
• Certification Potential: Yes - Leads to Exemplar Global QMS Lead Auditor Certification

• Abstract: Introduces managers, directors, and organizational leaders to Lean Six Sigma principles, methodologies (DMAIC framework), and key tools. Focuses on the Champion's role in selecting projects, removing barriers, sponsoring project teams, and driving a culture of continuous improvement.
• Estimated Duration: 1-Day
• Primary Focus Area: Cross-Industry (Process Improvement)
• Certification Potential: No

• Abstract: In-depth training program covering advanced Lean Six Sigma methodologies, statistical analysis tools (using software like Minitab), and project management skills. Equips participants to lead complex cross-functional process improvement projects and prepares them for Lean Six Sigma Black Belt certification.
• Estimated Duration: 10-Day (often split modules)
• Primary Focus Area: Cross-Industry (Process Improvement)
• Certification Potential: Yes - Leads to LSS Black Belt Certification

• Abstract: Advanced training designed for experienced and certified Black Belts. Focuses on strategic deployment of Lean Six Sigma within an organization, mentoring Black Belts and Green Belts, advanced statistical tools and techniques, and change management. Prepares candidates for Master Black Belt certification.
• Estimated Duration: 10-Day (often split modules)
• Primary Focus Area: Cross-Industry (Process Improvement)
• Certification Potential: Yes - Leads to LSS Master Black Belt Certification

• Abstract: Teaches practical techniques for developing clear, concise, user-friendly, and compliant Standard Operating Procedures (SOPs). Includes instruction on using process mapping tools (e.g., flowcharts) to visualize, analyze, and improve workflows within regulated environments. Applicable across all GxP industries.
• Estimated Duration: 1-Day
• Primary Focus Area: Cross-Industry
• Certification Potential: No