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Sunday, May 28, 2023
Home » Case Studies » IT Company Servicing Pharmaceutical and Medical Device Facilities

Challenge: Annual GMP Training for an IT Company Servicing Pharmaceutical and Medical Device Facilities

Background: Biopharma Institute helps pharmaceutical, clinical research, and medical device organizations reinforce the importance for sustaining compliance. This is achieved through employee awareness training, instructing the workers on how to be compliant, and describing why these federally mandated compliance rules must be followed. It is all about product safety.

Whether manufacturing food, cosmetics, medical devices, or pharmaceuticals, companies making these products are responsible for the safety of their consumers. If these rules are routinely reinforced upon employees through effective and documented training, and compliance is consistently followed, the company is demonstrating high performance in what is essential to manufacture products which are reliable, of high-quality and safe to use.

Companies choosing Biopharma Institute to educate and reinforce the importance of maintaining compliance are demonstrating they have put a high priority on preserving their product’s quality. When a company’s employees have a documented certificate of training from Biopharma Institute, it is demonstrating that they are putting a great prominence on delivering current and effective training to their workers.

CSV Computer System Validation
CSV Computer System Validation
Case Study: An IT company servicing pharmaceutical and medical device facilities is required to provide GMP training for their current 300 employees, and institute a training program for onboarding new employees; projected to be 10-15 per year. The IT company did not have their own learning management system (LMS), but they did have a system in place which was used to document employee training records.

The IT company decided to use Biopharma Institute’s On-Demand Training Manager Portal to easily issue training to employees and manage their training records. They decided to first use the Computer System Validation (CSV) Professional Certification Program (CSVPRO) to training their 300 current and experienced employees, as well for onboarding employees.

For the following years, the company decided to use different courses for the annual training of their current and experienced employees. The first year, they chose Compliance with Regulation 21 CFR Part 11 (Electronic Records and Electronic Signatures) (ESR01A). Annually, this IT company delivers a different course to their seasoned workers to reinforce the importance of compliance and keep their employees up to date on the mandated compliance regulations. Furthermore, the IT company has found it easy and efficient to export its employee training records using Biopharma Institute’s proprietary Training Manager Portal and import those records directly into their training management system.

This company understands that by reinforcing the importance of following the established guidelines through routine employee training is not only essential for the manufactured product’s quality and safety for the consumer; it is a federally mandated requirement.

Outcome: A cost-effective, easy-to-manage training program to provide continuous training for employees at various experience levels to remain complaint with mandated regulations. The company did not need to hire any additional staff to implement or manage their new training programs.

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Use the form below if you would like more information on our programs. You may want to request a quote on group training or an invoice for generating a company purchase order. For quotes or invoices please provide the course(s) and number of students. Alternatively, call toll-free from the US or Canada: +1 (888) 424-6576. International callers may dial: +1 (201) 301-8370.

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