Wide-ranging training courses available in the pharmaceutical, cannabis, and medical device industries.

Tenax Enterprises is a global leader in delivering quality, regulatory, and compliance solutions tailored to industries like pharmaceuticals, cannabis, medical devices, cosmetics, and information systems. Dedicated to helping organizations achieve operational excellence, Tenax Enterprises provides a comprehensive range of training courses to navigate complex regulatory requirements and manage quality standards effectively.  

An overview of the training philosophy at Tenax Enterprises.

At Tenax Enterprises, training goes beyond simply transferring knowledge—it’s about empowering professionals with the tools, insights, and confidence to thrive in highly regulated industries. Our courses are carefully designed to align with our services, such as regulatory strategy, quality assurance, compliance, QMS implementation, and audits. Each program is customised to address the distinct challenges faced by the pharmaceutical, cannabis, and medical device sectors, ensuring participants can apply their knowledge effectively in real-world situations.

Our programs are led by seasoned industry experts with deep expertise in global regulations, including those established by the South African Health Products Regulatory Authority (SAHPRA), BOMRA, U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), World Health Organisation (WHO), and other international authorities. We offer flexible formats, including in-person workshops, virtual sessions, and hybrid models, to suit various schedules and learning styles. Whether you’re a regulatory specialist, quality manager, or business owner, our training helps you achieve compliance, optimise processes, and foster sustainable success.

Check out our extensive range of training courses below.


Regulatory Affairs Training

Introduction to Regulatory Affairs

  • Overview of regulatory frameworks (FDA, EMA, SAHPRA, BOMRA, MCAZ, Health Canada, etc.)

  • Role of regulatory personnel in product lifecycle management

  • Key regulations for pharmaceuticals, medical devices, and cannabis (e.g., 21 CFR, EU MDR, SAHPRA guidelines, Cannabis Act)

Good Manufacturing Practices (GMP)

  • Principles of cGMP (current Good Manufacturing Practices)

  • GMP for pharmaceuticals (21 CFR Part 210/211, SAHPRA GMP guidelines, MCAZ standards)

  • GMP for medical devices (21 CFR Part 820, ISO 13485 as recognised by SAHPRA, BOMRA, MCAZ)

  • GMP for cannabis (e.g., GPP under Canada’s Cannabis Regulations; emerging standards via SAHPRA for medicinal cannabis)


Regulatory Submissions & Approvals

  • Preparing Investigational New Drug (IND) and New Drug Applications (NDA) for pharmaceuticals (FDA, EMA, SAHPRA, MCAZ)

  • Premarket Notification (510(k)) and Premarket Approval (PMA) for medical devices (FDA, EU MDR, SAHPRA risk-based classification)

  • Cannabis product licensing and registration processes (Health Canada, emerging SAHPRA medicinal cannabis guidelines, BOMRA oversight where applicable)

  • Global submission strategies (e.g., CE Marking, ICH guidelines, African harmonisation via AMRH)

Post-Market Surveillance & Reporting

  • Adverse event reporting (e.g., FDA MedWatch, EU MDR reporting, SAHPRA adverse drug reaction reporting, MCAZ pharmacovigilance)

  • Vigilance and pharmacovigilance requirements (EMA, SAHPRA, BOMRA, MCAZ)

  • Recalls, field actions, and market withdrawals (FDA, EMA, SAHPRA, MCAZ protocols)

Global Regulatory Compliance

  • Harmonisation standards (e.g., ICH, ISO 13485, African Medicines Regulatory Harmonisation (AMRH) initiatives)

  • Region-specific regulations (EU, US, Canada, South Africa via SAHPRA, Botswana via BOMRA, Zimbabwe via MCAZ)

  • Emerging markets and cannabis-specific international standards (WHO, limited African frameworks)

Quality Assurance & Quality Control Training

Fundamentals of QA & QC

  • Differences between QA and QC roles

  • Quality principles and risk-based approaches

  • Documentation and record-keeping best practices (FDA, EMA, SAHPRA, BOMRA, MCAZ)

Good Laboratory Practices (GLP)

  • GLP for non-clinical safety studies (FDA, EMA, SAHPRA, MCAZ guidelines)

  • Data integrity and laboratory compliance

  • QC testing for raw materials, in-process, and finished products (aligned with SAHPRA, BOMRA, MCAZ standards)

Batch Record Review & Release

  • Batch documentation requirements

  • QA review and approval processes

  • Release criteria for pharmaceuticals, devices, and cannabis products (FDA, EMA, SAHPRA, BOMRA, MCAZ)

Deviation, Non-Conformance & CAPA

  • Identifying and documenting deviations

  • Root cause analysis (RCA) techniques (e.g., 5 Whys, Fishbone)

  • Corrective and Preventive Actions (CAPA) implementation (FDA, EMA, SAHPRA, MCAZ expectations)

Supplier & Vendor Quality Management

  • Supplier audits and qualification (FDA, EMA, SAHPRA, BOMRA, MCAZ)

  • Quality agreements and oversight

  • Managing supply chain risks

Quality Management Systems (QMS) Training

Introduction to QMS

  • Core components of a QMS

  • Standards: ISO 9001, ISO 13485 (recognised by SAHPRA, BOMRA, MCAZ), ICH Q9/Q10

  • QMS for cannabis manufacturing (e.g., GPP alignment, SAHPRA medicinal cannabis standards)

Document Control & Management

  • SOP development, review, and approval

  • Change control processes

  • Electronic document management systems (aligned with FDA, EMA, SAHPRA, MCAZ)

Risk Management

  • Principles of ICH Q9 (Quality Risk Management)

  • Risk assessment tools (FMEA, PFMEA, HACCP)

  • Risk-based approaches for pharmaceuticals, devices, and cannabis (FDA, EMA, SAHPRA, BOMRA, MCAZ)

Internal & External Audits

  • Planning and conducting internal audits

  • Preparing for regulatory inspections (FDA, EMA, Health Canada, SAHPRA, BOMRA, MCAZ)

  • Audit response and follow-up strategies

QMS Implementation & Maintenance

  • Building a QMS from scratch

  • Continuous improvement (e.g., Plan-Do-Check-Act cycle)

  • Integration of QMS across multi-site operations (aligned with global and African standards)

Compliance Training

Data Integrity & Compliance

  • ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate)

  • Electronic records and signatures (21 CFR Part 11, SAHPRA, MCAZ guidelines)

  • Data governance in QC and manufacturing (FDA, EMA, BOMRA, MCAZ)

Good Documentation Practices (GDocP)

  • Principles of accurate, timely, and complete documentation.

  • Common documentation errors and how to avoid them

  • GDP for paper and electronic systems (FDA, EMA, SAHPRA, BOMRA, MCAZ)

Validation & Qualification

  • Process validation (pharmaceuticals and cannabis; FDA, EMA, SAHPRA, MCAZ)

  • Equipment and facility qualification (IQ, OQ, PQ)

  • Computer system validation (CSV) for QMS and manufacturing (FDA, EMA, SAHPRA)

Compliance with Emerging Regulations

  • Updates on cannabis regulations (e.g., edibles, extracts; Health Canada, SAHPRA medicinal cannabis)

  • EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)

  • Evolving FDA, SAHPRA, BOMRA, MCAZ, and global standards

Ethics & Compliance Culture

  • Building a culture of quality and compliance

  • Anti-bribery, anti-corruption, and conflict of interest policies

  • Whistleblower protections and reporting mechanisms

Sector-Specific Training

Pharmaceutical Industry Focus

  • Drug development lifecycle and regulatory requirements (FDA, EMA, SAHPRA, BOMRA, MCAZ)

  • Stability testing and shelf-life determination

  • Biologics and advanced therapy medicinal products (ATMPs)

Medical Device Industry Focus

  • Design controls and risk management (ISO 14971, recognized by SAHPRA, BOMRA, MCAZ)

  • Usability engineering (IEC 62366)

  • Software as a Medical Device (SaMD) compliance (FDA, EMA, SAHPRA)

Cannabis Industry Focus

  • Good Production Practices (GPP) for cannabis (Health Canada, emerging SAHPRA guidelines)

  • Testing for potency, contaminants, and pesticides (FDA, SAHPRA, MCAZ where applicable)

  • Packaging, labelling, and advertising compliance (Health Canada, SAHPRA medicinal cannabis rules)

Soft Skills & Leadership Training

Effective Communication for Quality & Regulatory Teams

  • Interfacing with regulators and auditors (FDA, EMA, SAHPRA, BOMRA, MCAZ)

  • Cross-functional collaboration (R&D, manufacturing, etc.)

Problem-Solving & Decision-Making

  • Analytical thinking for quality issues

  • Risk-based decision-making in regulatory contexts

Leadership in Quality & Compliance

  • Building and leading high-performing QA/QC teams

  • Driving a quality-first culture

  • Change management for QMS implementation

Delivery Methods

• In-Person Workshops: Hands-on, interactive sessions for practical application
• Online Training: Self-paced e-learning modules for flexibility
• Virtual Live Sessions: Real-time training with expert instructors
• Customised On-Site Training: Tailored to specific company needs, processes, and products
• Tailored Content: Customised courses based on the company’s specific products (e.g., biologics, Class II devices, cannabis edibles), size, and global markets (e.g., US, EU, South Africa, Botswana, Zimbabwe).
• Regulatory Updates: Sessions will include updates on recent and upcoming changes in regulations, such as FDA guidance, EU MDR, SAHPRA medicinal cannabis rules, or BOMRA/MCAZ developments.
• Practical Exercises: These will be incorporated into case studies, mock audits, and real-world scenarios.

Contact us.

info@tenaxenterprise.com
(012) 807-0392

Equestria
Pretoria, Gauteng 0184