Overview:
A compliant training program is essential for ensuring personnel in GMP, GCP, and quality system-regulated environments are knowledgeable, competent, and audit-ready.
This webinar will guide participants through the key regulatory requirements, best practices, and essential components of an effective training program, including defining training needs, developing engaging materials, assessing effectiveness, and maintaining proper documentation.
Attendees will also learn how to monitor compliance, address training gaps, and integrate digital tools to enhance learning outcomes. By the end of the session, participants will be equipped with practical strategies to build and sustain a training program that meets regulatory expectations and improves operational efficiency.
Why you should Attend:
Professionals working in GMP, GCP, and quality system-regulated environments must ensure their training programs meet stringent regulatory requirements to maintain compliance and operational excellence. This training provides participants with a comprehensive understanding of how to develop, implement, and manage an effective and audit-ready training program.
By attending, participants will gain insights into regulatory expectations, best practices for training development, documentation, and compliance monitoring, as well as strategies for continuous improvement. Whether responsible for training management, quality assurance, or regulatory compliance, attendees will leave with practical tools and knowledge to enhance their organization's training effectiveness and ensure readiness for inspections and audits.
Areas Covered in the Session:
- Introduction (5 minutes)
- Welcome and Speaker Introduction
- Objectives of the Webinar
- Importance of Training in Regulated Industries
- Regulatory Requirements for Training (10 minutes)
- Overview of GMP, GCP, and Quality System Regulations
- Key Regulatory Agencies: FDA, EMA, ICH, WHO
- Training Requirements in:
- GMP (21 CFR Part 210/211, EU GMP)
- GCP (ICH E6 R2, 21 CFR Part 50, 56)
- Quality Systems (ISO 13485, ICH Q10)
- Common Regulatory Findings Related to Training
- Core Elements of a Compliant Training Program (15 minutes)
- Defining Training Needs:
- Job roles and competency mapping
- Training frequency and retraining schedules
- Developing Training Materials:
- Standard Operating Procedures (SOPs)
- Work Instructions & Hands-on Training
- eLearning, Workshops, and On-the-Job Training
- Trainer Qualifications and Responsibilities
- Ensuring Training Effectiveness:
- Knowledge assessments and proficiency testing
- Practical applications and real-world scenarios
- Training Documentation and Record Keeping (10 minutes)
- What Must Be Documented?
- Training records, sign-in sheets, assessments
- Electronic vs. Paper-Based Systems
- Audit Readiness and Data Integrity Considerations
- Best Practices for Training Record Management
- Continuous Improvement and Compliance Monitoring (10 minutes)
- Monitoring Training Effectiveness:
- Performance metrics and KPIs
- Feedback mechanisms
- Handling Training Deficiencies and Retraining Needs
- Role of CAPA (Corrective and Preventive Actions) in Training
- Integration of Digital Tools and Learning Management Systems (LMS)
Who Will Benefit:
- Quality Assurance (QA) Managers
- Quality Control (QC) Personnel
- Training Managers
- Compliance Officers
- Regulatory Affairs Specialists
- GMP/GCP Auditors
- Clinical Research Associates (CRAs)
- Clinical Trial Managers
- Manufacturing Supervisors
- Production Operators
- Document Control Specialists
- Validation Specialists
- Laboratory Technicians
- R&D Scientists
- Supply Chain and Logistics Personnel in GMP-regulated industries
- Pharmacovigilance Professionals
- Medical Affairs Professionals