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
Offered at your location (internal/external) and at your convenience, Pharmazone Client Site Training services will bring any course to your team for personalized onsite technical training, or we can work with you to 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)
Live Online Courses (Webinar's) and Conference-Workshops
A webinar allows you to participate in an training event just by using the Internet.
During this kind of online training, you can see the speaker in a live Video and at the same time you can follow the speaker’s presentation right next to his Video.
In addition to participating in currently offered live webinars, you can also order recordings from past webinars – and watch them as needed on your PC.
Conference / Workshop
We are arranging conference and associated workshops at regular interval covering recent industry and / or regulatory trends and challenges. We bring on board the experts from industry and regulatory to present the current affairs and to address the issues most critical to industry in various technical specialties such as research & development (R&D), manufacturing, regulatory compliance and quality assurance (QA).
Learn From Anywhere
Pharmazone’s online technical courses give you the flexibility to be on the move and keep up with all your training needs.
Industry Experts and Key Topics
Get real-world insight and advice from practitioners in the field—the same award winning subject matter experts who teach the traditional in-person Client Site Training Programs.
Interactive Learning Experience
Instructor-led presentations in a virtual classroom engages attendees through the use of polling, tests, Q&A sessions and other online learning tools.
Save on travel costs and time out of the office. No hassle, no travel, no downtime.
All 60 and 90 minute accredited online training programs carry accreditation and/or certification.
Can’t make it to the Live Online Course?
All of our Live online courses are recorded and available for viewing as On-Demand Online Training Courses at your convenience.
Have a question about Pharmazone’s Live Online Training Courses?
We offer a series of online e-Learning modules that are used for GXP compliance training, or as part of an induction program to introduce new starters to SOP /GXP in Life Science industry.
These e-Learning modules can also be used as part of on-going GXP /SOP refresher training for existing personnel.
In addition, the courseware can be customized, if required, for your specific location or company and can be purchased for use on your own internal Learning Management Systems (LMS).
Access at any time (24 X 7 X 365)
Access via any computer, tablet or iPhone (or equivalent)
Built-in assessment questions and pass-mark, Certification post successful assessment.
Can be set up to provide training data for your compliance program.
Materials kept current and up-to-date as legislation changes
No need for an on-site trainer
Short modules with specific topics
Groups can undertake modules relevant to their role
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 (Standard Operating Procedure) training, GXP training, Safety and Environment training are also made mandatory to make certain that employees are equipped to work within the industry guidelines.
Since the training process is continuous, it becomes necessary to record and document all conducted training for the purpose of detailed audits.
Not only does non-compliance have serious legal repercussions, it also affects production quality and causes losses due to inefficiencies.
Traditionally, a paper-based system has been used in pharmaceutical organizations for documenting all training completions.
But as organizations grow in size and geographical spread, they have to switch to computerized systems to maintain efficiency.
The paper-based system fails to deliver in bigger organizations for many reasons. Firstly, the sheer bulk of the records to be maintained causes inefficiencies in the system.
It also makes audits difficult and tedious, which in turn causes further failings of the system.
However, the FDA (Food and Drug Administration) has mandated that Pharmaceutical Industry need to implement those systems which comply with Title 21 CFR Part 11 of the Code of Federal Regulations.
21 CFR Part 11 regulation specifies the FDA guidelines on electronic records and electronic signatures in the United States. Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records.
The systems implemented in the industry must also follow three protocols called IQ, OQ, and PQ. IQ stands for “Installation Qualification.”
The IQ records the installation of the software and ensures that the installation follows the correct steps.
OQ stands for “Operational Qualification.” The OQ tests or qualifies that the solution is working using test data in general.
PQ stands for “Performance Qualification,” which means that the application, under real-life conditions, consistently produces products which meet all predetermined requirements
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 IP/OQ/PQ protocols.
If the system does not maintain these compliance, FDA can impose serious penalties on the organizations.
Organizations must ensure that they partner with those LMS vendors which have significant experience in implementing LMS for Pharmaceutical companies.
The vendor and the system must have already undergone several audits on Title 21 CFR Part 11 and IP/OQ/PQ protocols.
Thus Pharmazone’s LMS “PZee” becomes the obvious choice as it has successfully implemented its PZee LMS for several pharmaceutical companies globally.
Notifications and reminders can be automatically sent through emails or SMS as soon as a trainee has been assigned a course. The frequency of these notifications can be customized as per need.
Gap analysis of required and completed training for all trainees can be conducted to assign training as per job descriptions. The LMS can be customized to conduct the analysis on a continuous basis or from time to time.
Rapid authoring tools can facilitate creation of e-courses on short notice, allowing the repository of available documents to grow rapidly. Updates and changes can also be made on these courses very easily, using the same tools.
Changes in training material (for instance SOPs) can automatically trigger a training alert to learners who need to be trained on the revised courses.
Reports of training 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 these 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.