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) and RCA system.
This course will cover CAPA and RCA methodology and documentation, diagnosing process improvement, developing options for process improvement and CAPA and RCA planning and implementation in practice of improvements.
Root cause analysis is the process by which we discover the underlying cause of difficulties in a business process or processes. Often businesses waste a great of money in fixing the symptoms of a problem, rather than the problem itself.
CAPA and RCA procedures are a frequent focus of regulatory inspectors and evidence will be required at any future inspections that CAPA actions have been implemented.
In this two-day course, participants learn to apply a systematic end-to-end process for analysing problems to uncover their root cause.
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 CAPA and RCA requirements. Anyone with the need to improve their ability to solve recurring problems including:
• Managers responsible for process and quality improvements
• Professionals working in R & D
• Quality Managers, Internal and External Auditors
• Line managers and supervisors
• Anyone involved in managing customer and/or supplier/CMOs/CRO relationships
• Problem solving team members and leaders
• Product or process designers
• Production and process operatives
• Anyone working in QMS
• Executives
• Project Managers
• Business Analysts
• Technicians
• Process improvement analysts
• Managers; supervisors, team leaders, and process users
Trainer
Key Topics
Learning Outcomes
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FAQ
The client has the right to cancel his/her registration in the event.
There is a 50% liability on all conference registrations once made, whether the booking was made through our website or via e–mail/ telephone/ fax.
If the client cancels with more than 8 weeks’s advance notice, GLC shall be entitled to an amount equivalent to 50% of the conference fee and 16 EUR administration charge. In case the client has already made his/her payment, this will be deducted from the conference fee GLC has already received and the remainder will be refunded. If no conference fee has been received prior to the cancellation request, GLC will issue an invoice for the cancellation fee (the amount equivalent to 50% of the conference fee and 16 EUR administration charge), which the client must pay immediately upon receipt. No refunds are available for cancellations received with 8 week’s (or less) advance notice or in case the client fails to attend the conference. In these cases, the full amount of the conference fee must be paid.
- Get the timing right.
Many people are afraid to request for training budget, because they can’t seem to find the “perfect time” to do it. Well, there’s no perfect time to ask for it, but there are definitely some moments that are better than others. For instance, if your boss is about to take a two week vacation, he/she might be in a good mood. If he/she just lost a major account, may not be wise at that juncture. - Make a case for yourself
When you ask for budget, you should be prepared with specific details and explanations about what is in it for the company and you’re superior. If you go into a meeting and just say, “I want to get budget for a conference,” it’s likely that your request won’t be taken seriously. If you want to plan ahead, then you should be prepared to explain the following points:
1. Start by stating your accomplishments
2. Show that you’re ready for more responsibility and eager to learn
3. Describe:
a) How this event will increase your productivity?
b) How you will need less supervision
c) How you can bring back the knowledge to the company
4. Follow up