With advancements in technology and automation tools, there is an industry-wide boom in data manipulation. CGMPs are not helping professionals combat data integrity and cybersecurity threats. This calls for adopting a realistic approach to identify gaps and correct them before it takes a toll on the entire system.
By the end of this seminar, you will be equipped to make your department comply with FDA, WHO, and EMA regulations. We are focusing on two major goals through cybersecurity training, which include:
- Protect patient and important pharmaceutical data by enforcing strict concepts of data integrity
- Build trust between regulatory agencies and the industry by upskilling the professionals in computer security
Keep reading to know the detailed overview of the course in the following sections.
FDA’s global inspectors have gone through thousands of manufacturing plants and reported irregular practices. Below are some burning problems in digital security which must be resolved through a cybersecurity course:
- Data falsification, omission, and elimination
- Unofficial sampling and testing to cover up unacceptable results
- Lack of controls in the data system or record which gives access to unauthorized officials
- Identity and data theft in the name of people who are not associated with the organization anymore
While most pharmaceutical companies and manufacturing plants are doing their best to deal with cybersecurity threats, professionals are not updated about the recent policies of the FDA.
By offering cybersecurity courses online, we are trying to bridge the knowledge gaps and share best practices with professionals like you. Data integrity and cybersecurity were never the centers of attention in a pharmaceutical company. However, it is now an important issue throughout the cycle of product development and manufacturing.
In the coming years, we are looking at increasing risks to data as electronic record-keeping and communication dominate. With a broader network, your department will be accessible to more outsiders. Hence, data integrity and cyber security courses online are leveraging educational and awareness campaigns for professionals.
Here is the agenda of one of the best cybersecurity courses available on our website:
Session 1: Data Integrity and 21 CFR 11
- Data Integrity Definitions
- FDA’s Guidance, Regulatory Expectations / Requirements
- 21 CFR 11, Electronic Records and E-Signature Requirements
- Validation Requirements
Session 2: Cybersecurity
- Cybersecurity Guidance Documents
- NIST Considerations
- Updates and Patches
Who Will Benefit From This Course?
When it comes to data integrity and cybersecurity threats, the first step is to be accountable and increase awareness. Since everyone in the management holds direct responsibility for accidental and intentional data breaches, cybersecurity training for professionals will do the damage control.
People who could benefit directly from the cybersecurity course offered by us are:
Tech and IT Team: People responsible for documentation, programming, and software development need to protect their work and agenda at every step.
Operations and Production: Since operations managers are responsible for maintaining the data integrity of the department, they must know the strategies to avoid data breaches.
Regulatory and Compliance Specialists: Internal audits play an important role in improving the quality of the overall data management system. Hence, compliance specialists must adhere to the latest norms.
Quality Assurance and Control Personnel: Documentation is an essential part of their work and processing each piece of data in a controlled manner will help in reducing data breaches.
People Also Ask
Q1 What does FDA require to ensure data integrity and cybersecurity systems are in place?
FDA has laid down strict regulations to enforce data integrity and cybersecurity in pharmaceutical and biological product development units. The guidelines cover major concerns like necessary controls, real-time documentation, ensuring data accuracy, and controlled access.
Q2 Why is the prevention of data breaches cost-effective?
There is no denying that dealing with inspection failures and warning letters is a huge financial burden for the firm. Your entire manufacturing unit or department is at stake if you fail to comply with regulatory norms. Hence, the best strategy is to upskill every professional so they can conduct regular internal audits to proofread the processes and operations.
Q3 Why is it essential to take a cybersecurity course?
Dealing with data integrity and cybersecurity threats can break you as a team or department. It is a long-term process that requires system validation from time to time. Additionally, internal auditing with a poor knowledge base can impact the accuracy of the data protection measures. However, staying updated with the help of cybersecurity courses online can reduce the labor and intensity of the task.