Customized Training Program
The Importance of Customized Training Programs
Training is both a necessity and an opportunity for life science organizations. It is also a significant focal point of regulatory authorities during inspections. Ensuring your people are competent, confident and continue to develop their knowledge and skills is vital to the ongoing success of our business, and even more so to patient safety. What is the best training approach to help mitigate a known or possible risk, and how do you know the training will be effective?
MEDVACON’s training experts have over 60 years of combined experience in all aspects of cGMP regulated environments. We understand training budgets must be allocated wisely. We begin each project with a specific needs assessment that allows us to fully understand all the contributing factors. Next, we develop and deliver specifically targeted solutions aimed at those factors. Finally, we provide mechanisms for determining the effectiveness of those solutions so you can provide objective evidence of the improvements. MEDVACON programs consistently focus on practical applications of requirements to everyday work life, and examine real-life scenarios to identify, develop and reinforce good decision-making. When competent people consistently make good decisions while performing their work as required, you have a great foundation for success.
Customized Training – Training for Supervisors and Leadership in cGMP-Regulated Environments
A Contract Manufacturing Organization (CMO) providing clients with aseptic manufacturing capacity identified the need for more timely and effective oversight from operational supervisors and managers. MEDVACON conducted a needs assessment, including interviews with personnel at all levels within the Manufacturing and Quality Assurance departments, along with a thorough review of current procedures, deviations, investigations and metrics.
MEDVACON identified multiple contributing factors, and designed and delivered a training program to focus on the compliance-, process- and human-related aspects of those gaps. People managers from Team Lead through Director level participated to ensure alignment and support from all levels of tactical management.
The program blended elements of traditional supervisor and leadership training with specific strategies for cultivating a culture of compliance and a “GMP Mindset” within teams. The environment created by the trainer enabled participants to openly discuss and mitigate the day-to-day challenges they faced in being able to be present and provide effective oversight as required by regulatory authorities. As a result, the effectiveness of time spent by front-line supervisors and managers with their teams improved, which had a quantifiable impact on product quality levels and customer satisfaction.
Customized Training – API Manufacturer
During MEDVACON’s on-site CSV initiative, the client identified the need for third-party training to improve right-first-time quality within the Operations group. Our needs assessment identified multiple contributing factors, including operator knowledge, clarity and consistency of processes and written procedures, and the availability of proper tools to perform the work. MEDVACON designed and delivered a highly interactive session that led operators, supervisors and managers through a process mapping exercise to identify and characterize compliance, process and product risks. Each time a risk was identified, the trainer and participants collaborated to identify practical, compliant and sustainable solutions. As a result, processes, procedures and batch records were updated, operator performance and engagement improved, and the rate of first-pass quality for manufactured products increased dramatically. The more common approach of retraining Operations personnel on applicable cGMP regulations and existing procedures would not have produced the outcome achieved through MEDVACON’s immersive on-site facilitation and training.