Training is an integral part of GMPs. The operations involved in the manufacture of regulated products are highly technical in nature. Inadequate training of personnel can result in products failing to meet the required standards. During inspections, regulatory agencies often find problems related to training programs.
PharmEng has been providing training programs to regulated industries for more than a decade. We customize our programs to fit client needs. Our course offerings include:
cGMPs/GLPs
- EU
- Health Canada
- FDA
Validation
- Computer Validation
- Cleaning Validation
- Process Validation
- Analytical Method Validation
Engineering
- Commissioning
- Design
- Decommissioning of Validated GxP systems
Regulatory Affairs
- Medical Devices
- Nutraceuticals
- Biotechnology
- Pharmaceutical
Quality Assurance
- Audit Programs
- CAPA
Manufacturing Processes
- Solid dosages
- Liquids/suspensions
- Biologicals
Our instructors are experienced professionals with diverse backgrounds from industry, government and academia. Course materials are developed in-house and are constantly updated to keep current with industry practices and changing regulatory environments.
The courses we provide include real-life examples from industry, with case studies and hands-on exercises to illustrate concepts.