Staying compliant and up-to-date with the latest regulatory standards is critical for businesses in the life science industry. This ensures patient safety, mitigates legal and financial risks, ensures seamless sales and distribution of products across different regions and improves reputation and brand integrity in the sector.
Challenges Associated with Staying Informed
Some of the biggest hurdles for companies include constantly evolving regulations, especially around new therapies, AI and digital health tools, and real-world evidence in clinical trials. Monitoring multiple global agencies such as FDA, EMA, MHRA, often requires close attention to align business practices according to outlined regulations.
For companies operating across multiple geographical territories, there are often different standards or overlapping requirements – not to mention language and cultural differences – that need to be considered. The high level of documentation needed and resource constraints internally can be especially challenging. Add the need to keep staff trained and aligned, and it can be very difficult to manage.
For such cases, training and guidance are not just a ‘nice to have’ – they are essential to future proof performance and streamline business efficiencies internally.
Your Needs. Analysed.
Navigating the seas of uncertainty around regulatory compliance needn’t be a solo mission. At Trinzo, we combine regulatory and quality expertise with best practice training methodologies.
The outcome? Training solutions designed by our expert team of QA/RA professionals that address your needs. The focus of our training courses is to equip your team with the necessary tools to elevate your standards. We offer a range of customised interactive training modules to facilitate your learning experience. Every business is different, and each is on their own learning path.
eLearning Courses
Start your journey today by choosing from one of our elearning courses—designed for convenience, flexibility and accessibility in mind.
We currently offer three interactive courses to help your team members onboard quickly and easily:
- Comprehensive CAPA (Corrective and Preventive Action). A key quality management process that helps identify, investigate and resolve issues. Required under several global standards such as FDA 21 CFR Part 820, ISO 13485 and ICH Q10, CAPA demonstrates accountability and proactive quality management; helps companies meet regulatory requirements and reduces the risk of product recalls.
This is a self-paced, 5 module and 4 hour course. Learn more.
- Introduction to PFAS (Per- and Polyfluoroalkyl Substances). PFAS is a large group of synthetic chemicals utilised for their resistance to heat, water and oil. They are used in manufacturing equipment or facility coatings, lab consumables and certain drug formulations or delivery systems. Evidence of PFAS necessitates close adherence to environmental safety assessments and PFAS testing; supply chain review to identify presence of PFAS; regulatory reporting/disclosures and remediation plans in the event of contamination, etc.
Compliance with EU-wide PFAS restrictions is vitally important and this 1-hour self-paced course offers a great opportunity to comprehend the scope of what is required. Learn more.
Note: Also check out our free, downloadable PFAS Acronym Guide.
- Post-Market Surveillance (PMS). A critical regulatory requirement designed to protect patients, PMS refers to the monitoring of a medical device’s safety, performance and compliance post-approval. PMS is mandated by FDA, EU MDR & IVDR, ICH E2E and ISO 13485. Failure to conduct adequate PMS can lead to regulatory penalties, product bans and a loss of public confidence.
A high-level overview of the role of PMS and its importance in the lifecycle of a medical device is provided in our 30 minute, self-paced course. Learn more.
These courses offer a good grounding in key areas for life science companies. A more thorough knowledge transfer can be delivered to clients on other specific areas as needed. Our team of subject matter experts provide expert consultancy and training solutions – such as Enterprise Excellence – which can accelerate your journey to compliance.
Book a free consultation and contact us today and learn more about how we can add value to your business.