Course overview
In today’s highly regulated pharma, biotech, device and animal health industries, it is essential to use the most efficient processes and ensure compliance with an active corrective and preventive action (CAPA) system.
CAPA procedures are a frequent focus of regulatory inspectors and evidence will be required at any future inspections that CAPA actions have been implemented.
This course will provide you with an understanding of how to improve your processes and implement and document an effective CAPA quality system. The programme will include discussion of CAPA examples and case studies to enhance course learning.
CPD Hours: 6
Course Content
- Day 1
- Why is CAPA important?
- Best practice for CAPA
- CAPA methodology and documentation
- Diagnosing process improvement
- Developing options for process improvement and CAPA
- Planning and implementation in process improvements and CAPA
Speakers
Farah Nadeem
Farah Nadeem is an Operations Manager at Paul R. Palmer Limited/ Pharmaceutical Consultant and a Trainee Qualified Person. Farah is a Pharmacist and recognised QA expert and has over 20 years of experience in the Pharmaceutical industry in the development, manufacture and supply of medicinal products.
Throughout her career, she has held various quality assurance roles and actively pursued new opportunities to expand her knowledge and expertise. As a result, she has gained a comprehensive understanding of manufacturing, storage, and distribution processes, as well as the facilities and services that support them. Involved in documentation management: writes, reviews, and audits SOPs and QMS implementations. Assists companies in meeting regulatory requirements.
In her current role as a QA Operations Manager for a Pharmaceutical Consultant Company, Farah Nadeem provides various solutions, including assistance in obtaining the first MIA(IMP) and MIA licenses, as well as preparation and hosting for regulatory inspections. Her work involves collaborating with Paul Palmer to offer services such as QP declarations for API manufacturers, regulatory inspection hosting, commercial and clinical batch release, compliance audits, and coaching and training in GxP.
Laura Brown
Dr Laura Brown is an independent pharmaceutical QA consultant and is a recognised expert in QA including auditing SOPs for regulatory compliance. She has more than 25 years’ international experience in the pharmaceutical industry in a number of senior roles and has worked for companies including GSK, Hoechst Marion Roussel, Farmitalia and Phoenix International. She has worked in several quality assurance roles which have included writing, reviewing and auditing SOPs and CAPA implementation and has helped companies prepare SOPs and review CAPA systems to meet regulatory requirements.
Aneta Jell
Aneta Jell is a seasoned Quality Assurance professional with over 20 years of experience across manufacturing, contract operations, and quality leadership in the pharmaceutical industry. Currently serving as Quality and training manager at PaulPalmer limited she oversees global contract manufacturing quality, ensuring GxP compliance, regulatory alignment, and supply chain integrity. Her expertise spans GMP, ISO 9001, ISO 17025, and QMS administration, with proven strength in audits, CAPA, deviations, and technical agreements. A qualified QMS lead auditor with bilingual proficiency in English and Slovak, Aneta is recognised for driving continuous improvement, fostering compliance culture, and leading high-performing quality and HSE teams.
Who Should Attend
Who should attend
This course has been specifically designed for those working in the pharma, biotech, device or animal health industries who are involved in process improvement and CAPA requirements.
