Better training means better outcomes.
MEDVACON’s training programs consistently focus on how, where and why cGMP requirements apply, and examine real-life scenarios to identify, develop and reinforce good decision-making.
Improving Performance is the Goal.
Training is both a necessity and an opportunity for Life Science organizations. Ensuring your people continue to develop their knowledge, skills and situational awareness is vital to the ongoing success of your business, and even more so to patient safety.
The Training project examples provided below illustrate that effective training can and should do more than simply check a box.
Example Projects and Outcomes
Training Improves Right-First-Time Quality for an API Manufacturer
During MEDVACON’s on-site Quality Gap Assessment, a critical need was identified to improve right-first-time quality within the Operations group. We conducted a detailed performance needs assessment that identified multiple contributing factors, including gaps in operator competency, unclear written procedures, and inconsistent availability of materials, tools and equipment. These factors led to extreme variation in how processes and tasks were performed, and thus high numbers of deviations and nearly zero right-first-time quality of work outputs.
MEDVACON designed and delivered a highly interactive session that guided operators, supervisors and managers through a process mapping exercise to identify and characterize compliance, process and product risks. Each time a risk or issue was identified, the trainer and participants worked together to develop practical, compliant and sustainable solutions, while simultaneously educating personnel on cGMP concepts, quality standards, industry best practices and management expectations.
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 simply retraining Operations personnel on applicable cGMP regulations and existing procedures would not have yielded the same outcomes as MEDVACON’s immersive on-site facilitation and training.
Training Eases the Transition to a cGMP Regulated Environment
MEDVACON was engaged by a renowned genomics laboratory new to the concept of meeting cGMP requirements. The client requested support with developing policies and procedures for Computer System Validation (CSV) and Software Development Life Cycle (SDLC), constructing and executing validation activities for several systems, and providing training for their Laboratory, Project Management and IT/Software Development staff.
MEDVACON Training experts worked closely with our CSV/SDLC consultants to develop and deliver a half-day training session, custom tailored to work through the newly developed policies and procedures while also providing context of cGMP regulations and expectations, including 21 CFR Part 11, GAMP5, and guidance documents from FDA, ICH, ISO, and PIC/S.
The training was well received by the client staff and proved instrumental in enhancing their applied knowledge of CSV, while enabling them to operate successfully within a cGMP environment.
Training Enables Shift of Quality’s Role from Enforcer to Trusted Partner
Following our on-site third-party audit of a Contract Manufacturing Organization (CMO), MEDVACON and the CMO’s Associate Director of Quality identified the need to shift how QA Managers provided oversight and how QA Auditors evaluated current compliance levels, and how both roles managed and mitigated compliance risks.
MEDVACON developed training for QA personnel with a dual focus. First, the training aimed to increase awareness of quality assurance and compliance standards and how they apply within a GMP-regulated CMO environment. Second, we sought to enhance the effectiveness of QA personnel, enabling them to become a more interactive and supportive partner who can quickly evaluate issues or gaps, and provide guidance, coaching, and instruction with confidence and tact.
The two-day immersive training program was highly interactive and successfully cultivated the situational awareness necessary for QA personnel to meet the new performance expectations of QA management. Improvements were observed not only in compliance and quality, but also in operational efficiency, schedule adherence and cross-functional collaboration.