How To Develop Effective Compliance Training In Pharmaceutical Firms With eLearning
It is a well-known fact that the pharmaceutical industry is heavily regulated. Companies in this sector need to comply with several regulatory standards prescribed by various agencies, and proper training on these standards is one of the key factors that help drug manufacturers prevent breaches of applicable norms.
Can Drug Makers Deliver High Quality Compliance Training?
For years, pharmaceutical companies have been training their employees on regulatory norms in instructor-led training, or in short ILT, sessions. This format of training is highly effective in educating learners about compliance aspects. However, in recent years, many drug makers are moving their regulatory affairs training programs online. Various factors, such as the necessity to cut costs and the need to train workforce in different parts of the world are resulting in the adoption of eLearning.
How Can eLearning Help Train Pharmaceutical Companies's Staff On Compliance Aspects?
The online learning format can be used to educate the staff of drug manufacturing companies on the following.
- Good manufacturing practices, also known as GMPs.
- Document controls and maintenance of records.
- Statutes pertaining to trials on human and animal test subjects.
- Regulations pertaining to safety.
- Intellectual property rights, or else IPRs.
- Anti-bribery laws.
- Prevention of off-label marketing of drugs.
1. Good Manufacturing Practices
You can use web-based learning modules to complement trainer-led sessions on Good Manufacturing Practices, also known as GMPs. Microlearning modules are useful to explain the guidelines, prescribed by the FDA and other organizations such as the World Health Organization (WHO), in a highly effective manner. One of our clients in the bio-pharmaceuticals space uses bite-sized online learning modules to train its staff on GMPs with a high degree of efficacy.
2. Document Controls And Maintenance Of Records
You can use self-paced technology, enabled learning materials to train your staff members on document control norms. Bite-sized online learning modules help provide a comprehensive understanding of the 21 CFR Part 11. eLearning modules spanning 3-7 minutes can be used fortraining personnel of pharmaceutical companies on the maintenance of master records, history records and quality system records prescribed by the Code of Federal Regulations.
3. Statutes Pertaining To Trials On Human And Animal Test Subjects
We all know that pharmaceutical companies conduct drug trials on animal and human test subjects. Web-based learning resources are useful to impart good training to the employees of these companies on the laws pertaining to trials on test subjects. For example, microlearning modules can be used to educate staff members on the FDA norms pertaining to clinical studies of anti-retro viral drugs. Likewise, manufacturers of live virus vaccines can use the online learning format fortraining their employees on the laws pertaining to tests on human subjects.
4. Regulations Pertaining To Safety
The technology-enabled learning format can be used for training the personnel of drug manufacturing companies on safety regulations with a high degree of efficacy. Scenario-based eLearning courses are very useful in helping learners understand the dangers of violating safety norms. For example, one of our clients uses scenario-based online learning modules to explain the consequences of not adhering to the Occupational Safety and Health Administration, in short OSHA, norms pertaining to the manufacture of diuretics.
5. Intellectual Property Rights
Web-based learning modules can be used to impart good training to the employees of pharmaceutical companies to prevent the violation of patents and other intellectual property rights, which are also popular as IPRs. Online learning resources containing case studies go a long way in making the personnel aware of the consequences of violating these rights. It is a good idea to create online checklists that your staff members can refer when they have doubts whether their actions constitute a breach of IPRs.
6. Anti-Bribery Laws
Pharmaceutical companies that resort to unethical means to increase their revenues, such as bribing physicians to prescribe their products, can face severe consequences, including huge fines and imprisonment of their executives. Microlearning videos, having spans of 3-7 minutes, are very useful to underscore the importance of adhering to anti-graft statutes. You can also incorporate case studies in eLearning courses to explain the implications of violating the statutes.
7. Prevention Of Off-Label Marketing Of Drugs
Off-label marketing refers to the promotion of a medicine for curing diseases other than what it is intended for. This practice is illegal and can attract serious penalties. Online learning modules containing scenarios can be used to train the sales staff of pharmaceutical companies on statutes pertaining to off-label marketing of drugs. You can also provide your medical reps mobile and compatible microlearning modules that list the conditions which a specific drug can treat.
Good compliance training plays a key role in helping pharmaceutical companies prevent violations of applicable rules. Harness the power of eLearning to impart high-quality training on regulatory norms to personnel of drug manufacturers.
