Device manufacturers often don’t have the time or the internal resources to train their staff. BioTeknica’s Ready Set Go! is a proprietary, interactive, hands-on coaching program where our personnel help you successfully train your team members in developing and executing validation protocols, performing test result analysis, and completing summary reports.
Our experienced BioTeknica Team Leaders will train your staff in a supportive atmosphere to ensure successful results. We offer a variety of customized classroom and hands-on options to fit your needs.
• Pre-Flight Training – This back-to-basics pre-Validation training option includes General Validation Classroom Training and Statistical Methods (Basic Statistics/Advanced Statistics/DOE/Process Validation) Classroom Training sessions.
Using the Ready Set Go! methodology, BioTeknica performs validation activities while providing hands-on training to your staff.
1. READY – First, our experts provide on-site workshops on the development of Validation Protocols for a process or specific equipment, e.g., a test method, control system, or even a facility. We lead the validation efforts, developing and executing protocols and producing summary reports while your team observes and oversees the methodology. Training skills categories include: Equipment Qualification, Process, Test Method, Computer System, and Cleaning Validation.
2. SET – Next, the roles are reversed as client trainees execute protocols, perform test result analysis, and complete summary reports developed during the READY phase, while the BioTeknica team observes, provides guidance, and reviews the outputs to ensure trainees are following guidance and best practices (e.g., GMP documentation).
3. GO – In this final phase, your team leads the validation efforts and BioTeknica performs a quality review using Validation Assessment Checklists. Each trainee is reviewed and receives feedback on significant deficiencies, industry best practices, standards, and guidelines. Trainees successfully demonstrate validation proficiency and receive certification upon completion of the program.
• FLIGHT – Your team has taken successful flight! To ensure certified individuals continue to demonstrate validation skill proficiency, BioTeknica Monitors or Re-Certifies your Validation protocols annually.
Contact us to learn how we can coach your team to success.
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