Overview
This essential webinar is tailored for professionals in the pharmaceutical industry seeking to excel in audits and enhance their quality standards. It will provide insights into best practices, techniques, and strategies for achieving excellence in internal and external audits, while also ensuring continuous quality improvement.
Key Points Covered
• Foundations of Audit Excellence
• Preparing for and Navigating Regulatory Audits
• Tools and Techniques for Quality Audits
• Real-World Examples of Successful Audits and Quality Improvements
• Strategies for Maintaining and Elevating Quality Standards Post-Audit
Target Audience
• Quality Assurance Managers and Auditors in the Pharmaceutical Industry
• Regulatory Affairs Professionals
• Compliance Officers
• Senior Management in Pharma and Biotech Companies
• Quality Control Personnel
- Introduction to Audit Excellence in Pharma
- Best Practices for Audit Preparation and Execution
- Overcoming Challenges in Regulatory Audits
- Tips and Techniques for Effective Auditing
- Q & A
Working as a Head of Global Pharmacovigilance for a multi-national innovator Company and EU QP PV for several of the top ten Pharma Companies, large generic and smaller innovative Pharma, Graeme is the CEO and Owner of PharSafer® – a position held for the last 19 years – and he has taken many products from bench to clinical to post-marketing in many global markets; helping many small start-up Companies (Biotech, Advanced Therapy, Medical Device, Biologic, Generics, Herbal, OTC) in their planning and growth, due-diligence activities for product in-licensing and marketing, and development strategies with partner and distributor Companies.
Graeme has also been involved in many global audits (conducted) and inspections (taken part in) for clients and also database designs and development.
