Elevate Your Compliance with
Expert Training
harmaceuticals
Navigating the complex landscape of pharmaceutical regulations is crucial for maintaining product quality and safety. Our training programs cover the FDA's Current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211), the European Medicines Agency (EMA) guidelines, MHRA's Human Medicines Regulations, Health Canada's GMP guidelines (GUI-0001), TGA's GMP requirements, and WHO's GMP standards. These regulations ensure your team understands the critical aspects of drug production, from raw material sourcing to final product testing.
Regulatory Compliance and Inspection: Prepare your team for inspections by FDA, EMA, MHRA, Health Canada, TGA, and WHO with our comprehensive training. We focus on compliance strategies, meticulous record-keeping, and robust quality management systems to help you avoid non-compliance issues such as warning letters or product recalls.
edical Devices & Combination Products
Our training programs provide in-depth knowledge of the Quality System Regulation (QSR) for medical devices (21 CFR part 820) and specific CGMP requirements for combination products (21 CFR part 4). We also cover EMA, MHRA, Health Canada, TGA, and WHO guidelines to ensure your products meet safety and performance standards throughout their lifecycle.
Regulatory Compliance and Inspection: Equip your team with the skills to handle inspections confidently. We cover routine, pre-approval, and for-cause inspections by FDA, EMA, MHRA, Health Canada, TGA, and WHO, emphasizing the importance of controlled manufacturing environments and adherence to regulatory standards.
iologics & Biosimilars
Stay ahead in the biologics and biosimilars market with our specialized training. We cover the Public Health Service Act, the Food, Drug, and Cosmetic Act, and specific FDA guidances for biosimilars, including 21 CFR part 600. Additionally, we include EMA, MHRA, Health Canada, TGA, and WHO guidelines to ensure sterility, potency, and purity.
Regulatory Compliance and Inspection: Our training programs focus on rigorous testing, validation, and continuous quality improvement practices. Prepare your team for inspections by FDA, EMA, MHRA, Health Canada, TGA, and WHO that verify adherence to CGMP standards and ensure product safety and efficacy.
esponsible Sourcing
Responsible sourcing is essential for maintaining ethical and sustainable practices. Our training covers key standards such as the ETI Base Code, SA 8000, ILO Conventions, ISO 14001, and ISO 26000. These standards ensure that your sourcing practices are ethical, environmentally sustainable, and socially responsible.
Regulatory Compliance and Inspection: Implement robust supplier qualification programs with our expert guidance. We train your team to conduct regular audits, verify supplier compliance with ethical practices, environmental regulations, and quality standards, and manage supply chain traceability according to the ETI Base Code, SA 8000, ILO Conventions, ISO 14001, and ISO 26000 standards.
GMP and Responsible Sourcing Auditor/Lead Auditor Training
Auditing Aspects Our CGMP and Responsible Sourcing Auditor/Lead Auditor training programs are designed to equip your team with the skills needed to conduct thorough and effective audits. These programs cover the entire audit cycle, from planning and conducting audits to reporting and follow-up. We emphasize the importance of understanding and applying relevant standards and guidelines, such as ISO 19011 for auditing management systems.
CGMP Auditor/Lead Auditor Training Our CGMP Auditor/Lead Auditor training provides comprehensive knowledge of pharmaceutical quality management systems, including ICH Q10 and relevant CGMP regulations. Participants will learn how to plan, conduct, report, and follow up on audits to ensure compliance with regulatory standards.
Responsible Sourcing Auditor/Lead Auditor Training Our Responsible Sourcing Auditor/Lead Auditor training covers key standards such as the ETI Base Code, SA 8000, ILO Conventions, ISO 14001, and ISO 26000. This training prepares your team to evaluate and improve responsible sourcing practices, ensuring ethical and sustainable supply chain management.
ata Integrity and Training
Importance of Data Integrity: Data integrity is a fundamental pillar in the pharmaceutical industry, ensuring the completeness, accuracy, and consistency of data throughout the product lifecycle. It is crucial for maintaining product quality, safety, and regulatory compliance.
Our data integrity training programs cover key concepts such as data collection, processing, storage, and retrieval. We emphasize the importance of robust documentation practices, standardized operating procedures, and regular audits to maintain data integrity. Participants will learn about regulatory expectations, including FDA, EMA, MHRA, Health Canada, TGA, and WHO guidelines, and best practices for ensuring data integrity in their operations.
PD Certification Training
Qualified Persons, Chartered Scientists, Chartered Chemists, and Quality Assurance Specialists: We offer CPD certification training for Qualified Persons, Chartered Scientists, Chartered Chemists, and Quality Assurance Specialists. Our programs are designed to help professionals maintain their certifications, enhance their skills, and stay current with industry standards. Our CPD training covers a wide range of topics, ensuring that your team remains competent and competitive in their respective fields.