Life Sciences Risk Management A to Z - Best Practices for Effectiveness and Efficiency training seminars presented by ComplianceOnline register now on FindaSeminar.com

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Life Sciences Risk Management A to Z - Best Practices for Effectiveness and Efficiency  

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The course is designed to service a wide range of participants from various disciplines within the pharmaceutical and medical device industry. Typically participants will be managers or supervisors who have experiences in a GMP related environment.

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Seminar Summary:

This highly interactive course consists of a lively mix of presentations, group exercises and discussions to provide an in-depth understanding of Quality Risk Management and know-how to be able to implement Quality Risk Management in the work place. (see full course description)

 

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Training Course Syllabus:


Life Sciences Risk Management A to Z - Best Practices for Effectiveness and Efficiency


Course Description:

Quality Risk Management is now at the cutting edge of the life sciences industry internationally. ICH Q9 Guideline on Quality Risk Management (QRM) was incorporated in GMP by the MHRA, PIC/S and the EMEA.

Regulators expect that Quality Risk Management (QRM) is inherently built into the backbone of the Quality Management System (QMS). Pharmaceutical professionals should be able to use risk management techniques and tools based on ICHQ9 to manage product quality, manufacturing processes, validation and compliance within a risk based Quality Management System.

Learning Objective:

General principles and approach to risk management
Regulatory requirements for application of risk principles
Key steps and activities for a risk management program
How compliance and risk management are strategically used
Principles and requirements of ICH Q9
How to classify cGMP non-conformances according to risk priority
Hazard Analysis and Critical Control Point (HACCP) in production and process control
How to apply risk management principles in process design
How to use HACCP tables to maintain process control of production lines
The different tools applicable to risk management
Failure Mode and Effect Analysis (FMEA) for an example pharmaceutical product
How to apply risk management to validation

Course Outline:
DAY ONE (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

8:30-10:15
General principles and approach to risk management
Regulatory requirements for application of risk principles
10:15-10:25
Tea break
10:25-12:00
Key steps and activities for a risk management program
12:00-1:00
Lunch
1:00-2:45
How compliance and risk management are strategically used
Principles and requirements of ICH Q9
2:45-2:55
Tea break
2:55-4:30
How to classify cGMP non-conformances according to risk priority

DAY TWO (8:30 AM – 4:30 PM)


8:30-10:15
Hazard Analysis and Critical Control Point (HACCP) in production and process control
How to apply risk management principles in process design
10:15-10:25
Tea break
10:25-12:00
How to use HACCP tables to maintain process control of production lines
12:00-1:00
Lunch
1:00-2:45
The different tools applicable to risk management
Failure Mode and Effect Analysis (FMEA) for an example pharmaceutical product
2:45-2:55
Tea break
2:55-4:30
How to apply risk management to validation

Seminar Summary:

This highly interactive course consists of a lively mix of presentations, group exercises and discussions to provide an in-depth understanding of Quality Risk Management and know-how to be able to implement Quality Risk Management in the work place. (see full course description)

print this agenda print agenda for the Life Sciences Risk Management A to Z - Best Practices for Effectiveness and Efficiency training seminar

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