Pharmaceutical Compliance Training
Stay Compliant. Stay Informed.
Explore our modules covering regulatory standards, ethical practices, and industry compliance
AdvaMed
AdvaMed
This course provides a clear understanding of the AdvaMed Code of Ethics, the industry standard governing ethical interactions between medical device companies and healthcare professionals (HCPs). Participants will learn key compliance principles for gifts, consulting agreements, and promotional activities in the med-tech sector.
Aggregate Spend for States
Aggregate Spend for States
This course deciphers the complex landscape of state-specific licensing, registration, transparency and gift laws affecting life sciences companies. Participants will gain actionable knowledge to comply with diverse licensing requirements, reporting regimes and gift restrictions across key jurisdictions, avoiding costly violations.
Anti-Kickback Statute (AKS)
Anti-Kickback Statute (AKS)
This course provides a comprehensive examination of the Federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b), a critical healthcare fraud and abuse law that prohibits improper financial arrangements in federal healthcare programs. Participants will gain practical knowledge of AKS requirements, safe harbors and enforcement trends.
Aseptic Techniques Training
Aseptic Techniques Training
This training covers the principles and practices of maintaining sterility to prevent infections in clinical and surgical settings. Participants will learn hand hygiene, sterile glove techniques, proper gowning, environmental controls, and instrument sterilization. The course is essential for operating room staff, nurses, and other healthcare professionals involved in invasive procedures.
Bloodborne Pathogen Training
Bloodborne Pathogen Training
This course educates healthcare workers on OSHA’s Bloodborne Pathogens Standard to minimize exposure risks to infectious diseases such as HIV, hepatitis B, and hepatitis C. Topics include exposure prevention, proper use of personal protective equipment (PPE), safe handling of sharps, post-exposure procedures, and waste disposal protocols. Annual training is required for at-risk personnel.
Continuing Medical Education Programs
Continuing Medical Education Programs
This course clarifies the vital role of Continuing Medical Education (CME) in advancing clinical practice while defining appropriate pharmaceutical industry involvement. Participants will learn to support accredited CME that prioritizes patient care, maintains independence, and complies with evolving standards.
Corporate Integrity Agreements (CIA)
Corporate Integrity Agreements (CIA)
This course provides a comprehensive understanding of Corporate Integrity Agreements (CIAs)—a critical compliance tool used by the U.S. government to monitor healthcare organizations following fraud settlements. Participants will learn the structure, obligations, and enforcement mechanisms of CIAs, as well as their impact on compliance programs and operations.
Dissemination of Materials
Dissemination of Materials
This course delivers essential clarity on compliant information dissemination within the pharmaceutical industry. Participants will gain critical insights into current regulatory concerns, learn to implement the latest FDA guidance updates, and master best practices for maintaining full compliance when sharing product information.
Electrical Safety Training
Electrical Safety Training
This training focuses on preventing electrical hazards in healthcare environments, including equipment malfunctions, shocks, and fires. Participants will learn about safe practices for medical device usage, proper grounding, inspection of electrical cords, and emergency response for electrical incidents.
Electronic Records and Electronic Signatures (21 CFR Part 11)
Electronic Records and Electronic Signatures (21 CFR Part 11)
This course provides a comprehensive understanding of 21 CFR Part 11 requirements for electronic records and signatures in FDA-regulated industries. Participants will learn how to implement compliant systems while meeting validation, security, and documentation standards.
False Claims Act (FCA)
False Claims Act (FCA)
This course provides a comprehensive understanding of the False Claims Act (FCA), a critical U.S. federal law aimed at combating fraud against government programs. Participants will explore the FCA’s legal framework, enforcement mechanisms, whistleblower provisions, and compliance strategies to mitigate risks in government contracting, healthcare, and other regulated industries.
FCC Laws and the Junk Fax Rules
FCC Laws and the Junk Fax Rules
This course provides a clear understanding of the Junk Fax Prevention Act (JFPA) and its amendments to the Telephone Consumer Protection Act (TCPA). Participants will learn the legal requirements for fax marketing, how to obtain proper consent, and strategies to avoid substantial penalties for non-compliance.
Credentialing Bundle
Credentialing Bundle
This bundle includes the following courses:
- National Patient Safety Goals Training
- Bloodborne Pathogen Training
- Aseptic Techniques Training
- Fire Safety Training
- Electrical Safety Training
- Medical Device Reporting
- Operating Room Protocol Training
- Radiation Safety Training
Drug Safety, Marketing & Communication Compliance
Drug Safety, Marketing & Communication Compliance
This specialized bundle equips professionals with critical knowledge of U.S. regulations governing prescription drug marketing, safety surveillance, and electronic communications. Covering both healthcare-specific and general commercial compliance, the courses address drug distribution laws (PDMA), risk management programs (REMS), adverse event monitoring (Pharmacovigilance), and digital outreach rules (CAN-SPAM/Junk Fax Laws)
Entering The US Pharmaceutical / Med Device Industry
Entering The US Pharmaceutical / Med Device Industry
This comprehensive bundle explores the critical aspects of pharmaceutical regulations, drug development, and federal oversight in the healthcare industry. The courses provide an in-depth understanding of the history and evolution of pharmaceutical regulations, the stages of a drug’s life cycle from discovery to post-market surveillance, the roles of key federal agencies in ensuring drug safety and efficacy, and the FDA’s Office of Prescription Drug Promotion (OPDP) in monitoring prescription drug advertising.
Federal Requirements
Federal Requirements
This essential bundle provides a deep dive into key U.S. healthcare compliance laws designed to prevent fraud, abuse, and corruption in the industry. Participants will gain a thorough understanding of the Anti-Kickback Statute (AKS), False Claims Act (FCA), Foreign Corrupt Practices Act (FCPA), and Stark Law, learning how these regulations impact healthcare providers, pharmaceutical companies, and medical organizations.
Pharmaceutical Compliance
Pharmaceutical Compliance
This comprehensive bundle provides an in-depth exploration of U.S. regulations governing drug and medical device labeling, marketing practices, and corporate compliance. Participants will gain critical insights into the Federal Food, Drug, and Cosmetic Act (FD&C Act), FDA labeling requirements, promotional material dissemination, and key industry codes while examining enforcement mechanisms like Corporate Integrity Agreements (CIAs).
Privacy and Security
Privacy and Security
This essential bundle provides a comprehensive exploration of healthcare data privacy, cybersecurity, and regulatory compliance across U.S. and global frameworks. Participants will gain expertise in HIPAA regulations, HITECH Act requirements, GDPR, state privacy laws, and electronic records standards to ensure lawful handling of protected health information (PHI) and sensitive data.
Sunshine Act Compliance
Sunshine Act Compliance
This essential compliance training package equips life sciences professionals with critical knowledge of federal and state transparency regulations governing healthcare provider (HCP) engagements. The bundle covers proper management of speaker programs, Sunshine Act (Open Payments) reporting requirements, and state-specific aggregate spend tracking obligations.