GxP Training Content: Now Available Directly in ZenQMS
Dozens of courses can be seamlessly added to the ZenQMS Training Module
Through a partnership with Biopharma Institute—experts in regulatory, validation, compliance, and GxP training—ZenQMS now offers over 75 high-quality courses for purchase and direct integration into our QMS platform
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GxP Content in a System You TrustYou can access, assign, and track training content directly within your ZenQMS instance. No need to validate or manage a separate LMS.
Content by SMEs, for Aspiring SMEsBiopharma Institute's content is written and curated by Life Sciences industry experts across GxP, regulatory affairs, validation, drug safety, etc.
Always Current, Always CompliantNo need to spend hours monitoring and revising training content. Courses are always kept up-to-date with the latest regulatory and compliance requirements.
Over 75 up-to-date courses spanning GxP, regulatory compliance, validation, and more!
Whether you're a biopharma sponsor, CRO, CMO, or any GxP regulated organization, our comprehensive course library has your training needs covered.Good Clinical Practices
- GCP: ICH-GCP Good Clinical Practice E6(R3)
- Clinical Trials in Drug Development (Fundamentals)
- Clinical Trials: Protocol Design (Fundamentals)
- Clinical Trials: Preparation (Fundamentals)
- Clinical Trials: Endpoints (Fundamentals)
- Clinical Trials: Statistical Elements (Fundamentals)
- Clinical Trials: Study Design (Fundamentals)
- Clinical Trials: Data Capture (Fundamentals)
- GCP: ICH, Harmonization, and Principles of GCP ICH E6(R3)
- GCP: Clinical Research Teamwork (Fundamentals)
- GCP: Clinical Trial GCP ICH E6(R3) Records and Data Governance (Fundamentals)
- GCP: Clinical Trial Sponsors GCP ICH E6(R3) Responsibilities (Fundamentals)
- GCP: Clinical Trial Investigators GCP ICH E6(R3) Responsibilities (Fundamentals)
- GCP: Informed Consent in Clinical Trials (Fundamentals)
- GCP: Clinical Trial Monitors GCP ICH E6(R3) Responsibilities (Fundamentals)
Good Manufacturing Practices
- cGMP: What is GMP and Why is it Important (Fundamentals)
- cGMP: The Principles of GMP (Fundamentals)
- cGMP: Hygiene, Cleaning, and Sanitation (Fundamentals)
- cGMP: Documentation and Record Keeping (Fundamentals)
- GxP: Good Practices (GxP) in Drug Development and Manufacturing
- cGMP: Introduction to Good Manufacturing Practice for Medicinal Products
- cGMP: Good Documentation Practice (GDocP)
- cGMP: Good Manufacturing Practice in Cleaning and Sanitation
- cGMP: Good Manufacturing Practice for the Warehouse
- cGMP: Good Manufacturing Practice in Processing Medicinal Products
- cGMP: Good Manufacturing Practice in Packaging Medicinal Products
- cGMP: Corrective and Preventive Action (CAPA) in Medicinal Product Manufacturing - Including Root Cause Analysis
Regulatory Affairs
- Essentials for Human Medicinal Products
- Orphan Drug Application
- Preparing Submissions in the Common Technical Document (CTD) Format
- Electronic Common Technical Document (eCTD)
- Registration of Drugs Based on Monoclonal Antibodies
- How to Gain Approval to Market Generic Drugs in the USA
- Submitting a New Drug Application (NDA) to Obtain Approval to Market in the USA
- The Regulatory Pathway to Licensing Follow-on Biologics (Biosimilars) in the USA
- The European Centralized Procedure (CP)
- The Mutual Recognition Procedure (MRP)
- Variations to Marketing Authorizations in Europe
- The Decentralized Procedure (DCP)
- Essentials of Monoclonal Antibodies
- The Biologics License Application (BLA) for Marketing Approval in the USA
- The 505(b)(2) Application for Marketing Approval in the USA
Drug Safety
- Safety Reporting in Clinical Trials (Adverse Event Reporting)
- Clinical Trial Safety Reporting Requirements in the EU and USA
- Introduction to Drug Safety and Pharmacovigilance
- Drug Safety: Signal Detection and Management in Pharmacovigilance
- Drug Safety: Risk Management Planning for Medicinal Products
- Drug Safety: Urgent Safety Restrictions
- Drug Safety: Good Pharmacoepidemiology Practice
- Introduction to Pharmacokinetics and Pharmacodynamics in Drug Development and Registration
- Conducting Pharmacokinetic and Pharmacodynamic Studies
Other Courses
- Assuring Data Integrity in Clinical Research
- Assuring Data Integrity in the Manufacture of Medicinal Products
- Compliance with Regulation 21 CFR Part 11 (Electronic Records and Electronic Signatures)
- G(QC)LP: Good Quality Control Laboratory Practice
- Good Clinical Laboratory Practice (GCLP)
- Good Laboratory Practice (GLP)
- Validation: Commissioning and Installation Qualification (IQ)
- Validation: Computer System Validation (Part 1 of 2) (Planning)
- Validation: Computer System Validation (Part 2 of 2) (Implementation)
- Validation: Equipment Cleaning Validation
- Validation: Introduction to Validation
- Validation: Operational and Performance Qualification (OQ/PQ)
- Validation: Plans and Documentation
- …and more!
Frequently Asked Questions
Who is Biopharma Institute?
Biopharma Institute is a premier training provider specializing in regulatory, compliance, and GxP education for the pharmaceutical, biotechnology, and medical device industries. They have provided high-quality training to the Life Sciences industry since 2003 and have won several awards such as 'Best Pharma Training Provider' from Global Health & Pharma. They are true subject matter experts who care deeply about delivering the highest quality training content to the industry.
How do I buy training content?
Training courses are a paid add-on annual subscription and can be purchased a la carte. Alternatively, we may be able to provide licenses to multiple courses (or the entire catalog) depending on your organizations needs. Reach out to your account contact or email sales@zenqms.com to set up a discussion.
How often is the content updated?
Biopharma Institute reviews and updates its content regularly—typically on an annual basis—to align with evolving global regulations and best practices. Updates may include minor cosmetic changes (e.g., correcting a typo) or significant updates driven by new regulatory requirements. This ensures clients have a consistent training experience while always maintaining compliance with the latest standards.
Does my company need to activate SCORM in ZenQMS to access training content?
Yes. Because this library of training content is SCORM-compatible, it requires that your organization activate the paid SCORM add-on.