We partner with our life sciences clients to provide effective, efficient and sustainable training solutions that drive their businesses forward. Our needs-based approach enhances employee and operational performance while mitigating compliance and business risks.
From needs assessment through design and delivery, we build sustainable training systems that require minimal resources and are woven through all departments and systems.
We drive metrics into the process at every stage to reduce training-related compliance risk, while simultaneously enhancing quality systems to prepare your company for regulatory evaluation.
Contact us to discuss the various Training Solutions that we have (Listed Below) to offer so as to jointly identify the blended solution to meet your requirements.
End to End Training Process Outsourcing to Pharmazone for effective compliance and enhanced operational performance of your employees.
We partner in setting up training department – Training SOP, Formats, Metrics, Train-the-Trainer, Creating Content, Delivery, Assessments, Personnel Qualification and Maintenance of Personnel Training Record.
Creating Content for a particular Topic
Training Systems Audit and Gap Analysis
Client Site Training Program - Classroom
Pharmazone Client Site Training services will bring,
Any course to your team for personalized onsite technical training
Offered at your location (internal/external) and at your convenience
Develop a program to address the issues most critical to your company in various technical specialties such as research & development (R&D), manufacturing, regulatory compliance and quality assurance (QA)
We offer a series of online e-Learning modules that are used for GxP compliance training viz.,
An induction program to introduce new starters to SOP / GxP
As part of on-going SOP / GxP refresher training
Customized course for use on your existing Learning Management Systems (LMS)
Access at any time (24 X 7 X 365) via any computer/tablet
Built-in assessment questions and Certification with Ready training log
Up to date Materials and No need for an on-site trainer
Short modules with specific topics and Role specific modules
Learning Management System
The pharmaceutical industry is governed by a variety of laws and regulations to ensure the safety and efficacy of its products.
In addition to SOP training, GxP training, Safety and Environment training are also made mandatory to make certain that employees are equipped to work within the industry guidelines. LMS is the key tool and helps to solve the following challenges…
Recording all conducted training for the purpose of audits, as the training is continuous process.
Avoiding non-compliance which affects production quality and causes loss due to inefficiencies.
Moving over the Traditional paper-based system used for documenting training.
Switching to computerized systems to maintain efficiency as organizations grow in size and geography.
Avoiding the inefficiencies due to sheer bulk of the records which may failure of the paper-based system.
Failings the system further as paper based system makes audits difficult and tedious.
Compliance with 21 CFR Part 11
Following the three protocols IQ-OQ-PQ.
IQ – recording the installation of the software and ensuring that the installation follows the correct steps.
OQ – testing or qualifying that the solution is working using test data in general.
PQ – meeting predetermined requirements of the application, under real-life conditions
While there are several Learning management Systems available in the market, only a few can help pharmaceutical companies to comply with Title 21 CFR Part 11 and IQ/OQ/PQ protocols.
As FDA can impose serious penalties on the organizations in case of non-compliance, organizations must partner with LMS vendors with significant experience in implementing LMS for Pharmaceutical companies.
The vendor and the system must have undergone several audits/inspection on Title 21 CFR Part 11 and IQ/OQ/PQ protocols.
Thus Pharmazone’s LMS “PZee” becomes the obvious choice as PZee LMS is successfully implemented at several pharmaceutical sites globally.
Notifications and reminders through emails or SMS as soon as a trainee has been assigned a course.
Customized frequency of the notifications / reminders.
Analysis of required and completed training for all trainees as per job descriptions.
Customized modules to conduct the analysis on a continuous basis.
Rapid authoring tools to facilitate creation of e-courses on short notice.
Easy updates on the existing courses.
Changes in training material (for instance SOPs) can automatically trigger an alert to learner who needs to be trained on the revised courses.
Training Reports planned and completed for each employee are available at all times, easing the audit process.
Online assessments for courses can be conducted with the help of quizzes and tests with randomized questions.
Records of the test evaluations are available at all times for audit purposes.
The Training Management System not only helps organizations comply with mandatory trainings but also helps in increasing the efficiency of the workforce and achieving excellence in product quality.