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Training and personal qualification

• The training and qualification program is designed to train personnel involved in the manufacture and testing of biopharmaceuticals in compliance with Current Good Manufacturing Practice (cGMP) and Good Laboratory Practices (GLP). Training is job-specific, initiated upon hire, and maintained throughout employment to ensure competence in assigned responsibilities. Multiple training methods are used, including reading SOPs, on-the-job training, standardized courses, competency assessments, and external courses, with Quality Assurance providing oversight.

4 hr

Created by Dr. YASSER MEKKY

EN/AR [Auto]

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# Content
1 • Module 1: Foundations of Personal Qualification & Self-Assessment
2 • Module 2: Professional Communication & Interpersonal Skills
3 • Module 3: Emotional Intelligence (EI) & Resilience
4 • Module 4: Time Management, Productivity & Organization
5 • Module 5: Leadership, Teamwork & Collaboration
6 • Module 6: Problem-Solving, Critical Thinking & Decision Making
7 • Module 7: Action Planning & Continuous Professional Development (CPD)
# Outcomes
• Demonstrated competence in job-specific tasks and responsibilities.
• Understanding and application of cGMP regulations and company SOPs.
• Ability to independently perform assigned processes with validated competency.
• Completion of required training modules including GMP orientation and documentation practices.
• For some analytical tests, successful certification before independent execution.
Maintenance of up-to-date training documented in the electronic system.
# Participants
1
• New hires entering cGMP environments.
2
• Existing employees with ongoing job-specific or refresher training requirements.
3
• Managers and supervisors responsible for employee training oversight.
4
• Trainers including subject matter experts (SMEs), managers, supervisors, or outside contractors.
5
• Service providers or visiting scientists requiring training for their scope of work.