Our training program will guide IT personnel, QA managers, operational managers and users of computer hardware and software through the entire high level validation process applicable for various type of computer based systems available in pharmaceutical and life science environment. Risk assessment and risk based validation will be discussed to optimize validation efforts. The training program constitutes of the following.
Attendance Suggested for:
- Demonstrate fundamentals and principles of Computer System Validation
- Generate key validation documents such as URS, VMP, Risk Plan etc following GAMP 5
- Understanding the requirements of US FDA 21CFR Part 11 and EU ANNEXURE 11
- Familiarizing the participants with GAMP5 based GxP testing approaches
- Understanding the requirements of Data Integrity and managing the same
- How to handle Audits
Please download Training Brochure.
- Quality assurance and quality control specialists, validation specialists, manufacturing supervisors, technical support personnel, engineers, MIS professionals and all levels of management who need a fundamental understanding of computerized system compliance and regulations
- Computer system vendors or consultants, engineering contractors, and validation service companies
- "Good Programme. In future IT person will be encouraged to attend the same"
- Percy Italia, JRF
- "Very easy to understand for the person new to domain. The workshop was conducted in very good manner"
- Vinodh Mohan
- "The objective of trainings were well defined and trainers were knowledgeable about the topics"
- Sun Pharma
- "The training will be useful in my current work."
- Sidmak Laboratories
- "All Questions asked during sessions were adequately answered"
- Sujata, Zifotech