- Proper training ensures product quality, safety, and regulatory compliance.
- Training programs should be well-documented, regularly updated, and tailored to employee roles.
Importance of Training
- Training equips employees with the knowledge and skills needed to meet quality standards, understand their responsibilities, and comply with regulations.
Types of Training
- Induction Training: For new employees to familiarize them with company policies, GMP, SOPs, and safety procedures.
- On-the-Job Training (OJT): Hands-on training provided under supervision for specific tasks and responsibilities.
- GMP Training: Regular training on Good Manufacturing Practices to ensure compliance.
- SOP Training: Personnel must be trained on relevant Standard Operating Procedures (SOPs) before performing tasks.
- Hygiene and Safety Training: Covers personal hygiene, gowning procedures, handling of hazardous materials, and emergency protocols.
- Data Integrity Training: Ensures compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).
Training Documentation
- Comprehensive training records are maintained, including:
- Date of training.
- Trainer’s qualifications.
- Attendance records.
- Evaluation and certification results.
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