The team is made up of ValSource’s “senior knowledge group,” including consultants in microbiology, contamination prevention, process control, validation, data integrity, training, quality risk management, regulatory expectations, and quality system implementation.
"Time is critical when help is needed, especially when a regulatory response is needed in a defined period of time,” ValSource Microbiology and Regulatory Consultant Dave Hussong told Outsourcing-Pharma.com.
“Too often, finding a consultant who is available and has the needed skill set takes too much of that time as the response deadline approaches.”
The team reviews technical and regulatory materials and presents findings to address regulatory concerns, microbiological procedures, data management, and acceptance criteria, according to the company.
“The ability to assemble individuals with specific knowledge, skills and experience means that there is support focused on each specific issue among a range of problem areas,” he added. “Multiple subject matter experts can come together and quickly resolve a client’s issues to meet the range of needs when the team divides this workload and can focus on concerns in the range of their expertise.”