TRAINING
Isha’s GMP is committed to helping ensure clients’ long-term success and effectiveness with compliance and regulatory issues, as well as regulatory affairs. Offers a full complement of training programs for all levels of an organization—from senior executives to bench chemists and manufacturing operators.
Training programs can be customized to meet each organization’s requirements. In addition to classroom training, is also able to deliver on-the-job training and “train the trainer” services.
These are some of the training programs offers:
Essential Programs for Senior and Mid-Level Management
- Corporate and Individual Responsibility and Legal Liability for Compliance
- Risk Management
GMP Programs
- GMP training for manufacturing and laboratory personnel
- Overview of GMPs for the 21st Century
- Risk-Based GMP Inspections
- FDA Pre-Approval Inspections
- Preparing for an Inspection and Interacting with the Investigator
- Integrity of Records and Data
Regulatory Programs
- Regulatory Approaches to Product Development, Quality Evaluation and Clinical Assessment – Combination Drug Products and Medical Devices
- Regulatory Aspects of Life Cycle Management