NSF International provides a comprehensive range of support services for the pharmaceutical industry covering consulting and regulatory guidance, training and auditing on a global basis.
We combine experienced industry professionals with former regulatory agency staff (FDA, MHRA, etc) to deliver a unique team that will help you achieve and maintain compliant, future-proof pharmaceutical quality systems.
We offer the following services:
• Development and implementation of cost-effective, compliant pharmaceutical quality systems
• Advice on design, qualification and validation of new facilities, equipment, computerized systems and processes
• Legal and regulatory issue guidance
• Assistance with responses to regulatory inspection reports
• Simplification of quality processes, SOPs and batch records
• Advice on specific technical problems
• Benchmarking against best industry practices – beyond the regulations
We also offer full clinical trial services, helping pharmaceutical companies conduct scientifically sound clinical trials and navigate complex regulatory environments in a wide range of therapeutic indications, including, but not limited to, oncology, central nervous system, wound healing, infectious disease, cardiovascular and urology.
Taking a closer look at your facilities and operations through on-site and remote audits.
NSF perform audits against Good Manufacturing Practice, Good Distribution Practice, Good Pharmacovigilance Practice and Good Clinical Practice international regulations.
We audit active pharmaceutical ingredients, excipients, medicinal product manufacturers, distributors, investigational medicinal product manufacturers, QC laboratories, affiliates, contract manufacturers, computerized systems and more.
Our processes can be tailored to your specific needs, including:
• Due diligence audits
• Compliance auditing – assessment of activities against standards
• Inspection readiness audits
• Auditing your supplier
• Audits of your internal audit processes
Outputs can include efficiently reaching compliance.
Training and Education
We provide virtual instructor-led training, eLearning, in-person and customised training.
You are only as good as your people. We offer education programmes that will change behaviours, improve performance and “future proof” your organisation.
Examples of education offered annually include:
• Good Manufacturing Practice, including clinical trials
• Regulatory updates and regulatory affairs
• Auditing and self-inspections (including a CQI- and IRCA-certified course)
• Sterile and biotech products manufacture
• Quality risk management
• Changing GMP behaviours
• Data integrity
• Process and cleaning validation
• Deviation and CAPA management
• Responsible Person and Good Distribution Practice
• Supplier management
• Pharmaceutical Qualified Person training, working alongside the University of Strathclyde
17 November 2020
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