About this course
This full day workshop will be invaluable to those individuals involved with the management of the Deviation and CAPA systems. In addition, attendance is recommended for those who are responsible for ensuring preventative actions will provide lasting quality assurance.
Morning 08:30 – 12:00
- Best Practices for Deviation Investigations
If you only wish to book the morning session on-line follow this link
Afternoon 13:00 – 16:30
- Best Practices for CAPA Management
If you only wish to book the afternoon session on-line follow this link
Course outline
Morning 08:30 – 12:00
Best Practices for Deviation Management
This short course will review key requirements for handling deviations and GMP investigations in pharmaceutical and biopharmaceutical operations. Applying risk-based approaches and triaging methodologies will ensure time is devoted to the most important and sensitive investigations. Best practices for deviation management are reviewed and discussed. The input is invaluable to individuals managing and/or seeking to improve their company deviation handling systems.
Afternoon 13:00 – 16:30
Best Practices for CAPA Management
CAPA systems can overwhelm a facility if not well managed. This course will review key components of a well-managed CAPA system. System weakness will be reviewed along with measures which will tell you whether your CAPA system is functioning for company benefit. Regulatory expectations for CAPA systems are highlighted along with methodologies for appropriate effectiveness checks.
The instructors have been closely involved in deviation handling and system improvement and have interfaced with agency inspectors on a variety of difficult investigations and challenging CAPAs. Case studies are used to facilitate discussing best practices in deviation and CAPA management.
Discussion and Working Groups
A significant proportion of the course time will be devoted to group work, where delegates have the opportunity, through case studies, to put theory into practice.
Additionally, discussion periods, provide delegates with an opportunity to obtain answers to their specific questions and concerns.
Venue
NSF Health Sciences Boston Office, Boston, MA, USA
These courses will take place in the
The Washington Marriott
1221 22nd St NW
Phone: (202) 872-1500
Washington, District of Columbia 20037
United States
Tutors
We believe that our team of experts are the best available. Not only have they got years of experience in the industry, but they are committed to tutoring and helping those inside the industry to improve and raise the standards. We understand that you attend courses to learn about the latest regulations and to get your questions answered.
Our expert for this course is:
An NSF International Company 
