Live -Webinar 2014 - Best Practices for Quality Risk Management for Pharmaceutical Industry
Topics/Call fo Papers
DESCRIPTION
Firms in pharmaceuticals including those manufacturing biosimilars and biologics, who are intending to bring products into the US market, are subject to quality risk management (QRM).
This presentation is intended to help you get familiar with best practices for the QRM applicable for pharmaceutical industry (drugs, biosimilars, and biologics).
This seminar is further intended to discuss how quality risk management can be effectively integrated into a quality system (QS) in the pharmaceutical industry.
This seminar will help attendees understand risk management principles, risk management tools, methods and processes applicable to the pharmaceutical industry. In addition, this seminar will help the attendees how to develop and implement a systematic and holistic risk management strategy integrated into the quality system.
This 60-min webinar will provide great opportunities for you to get familiar with the details of how to implement the systematic and holistic quality risk management for drugs, biosimilars and biologics.
Why should you attend :
This webinar is intended to help you learn and ensure you can adequately implement quality risk management (QRM) applicable for pharmaceutical industry (drugs, biosimilars, and biologics).
Areas Covered in the Session:
Laws, Regulations, Rules and/or Standards
Definitions
Risk Management (RM) Process ? Systematic and Integrated
RM Principles
Risk Management Tools and Methods
Risk Ranking
How to Facilitate Quality Risk Management
Common Mistakes and How to Prevent Common Pitfalls
Risk Control Measures
Risk Communication ? How
RM Applications for Operations, R&D, Materials, Facilities, Utilities, Equipment, Manufacturing, Labeling and Packaging, Laboratory Studies and Quality Control.
Doing RM Right Without Wasting Resources
Practical Aspects (Value) of Risk Management
Relationship with Other Quality Subsystems
Common Pitfalls and Misconception
How to Avoid Common Mistakes
Implementing RM in an Efficient and Effective Manner.
Speaker’s Practical PASS-IT Guide?
Who will benefit: (Titles)
CEOs
VPs
Compliance officers
Attorneys
Clinical affairs (associates, specialists, managers, directors or VPs)
Regulatory affairs (associates, specialists, managers, directors or VPs)
Quality assurance (associates, specialists, managers, directors or VPs)
R&D (engineers, scientists, managers, directors or VPs)
CROs
Consultants
Contractors/subcontractors
Webinar Includes:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
60 Minutes Live Presentation
Certificate of Attendance
Firms in pharmaceuticals including those manufacturing biosimilars and biologics, who are intending to bring products into the US market, are subject to quality risk management (QRM).
This presentation is intended to help you get familiar with best practices for the QRM applicable for pharmaceutical industry (drugs, biosimilars, and biologics).
This seminar is further intended to discuss how quality risk management can be effectively integrated into a quality system (QS) in the pharmaceutical industry.
This seminar will help attendees understand risk management principles, risk management tools, methods and processes applicable to the pharmaceutical industry. In addition, this seminar will help the attendees how to develop and implement a systematic and holistic risk management strategy integrated into the quality system.
This 60-min webinar will provide great opportunities for you to get familiar with the details of how to implement the systematic and holistic quality risk management for drugs, biosimilars and biologics.
Why should you attend :
This webinar is intended to help you learn and ensure you can adequately implement quality risk management (QRM) applicable for pharmaceutical industry (drugs, biosimilars, and biologics).
Areas Covered in the Session:
Laws, Regulations, Rules and/or Standards
Definitions
Risk Management (RM) Process ? Systematic and Integrated
RM Principles
Risk Management Tools and Methods
Risk Ranking
How to Facilitate Quality Risk Management
Common Mistakes and How to Prevent Common Pitfalls
Risk Control Measures
Risk Communication ? How
RM Applications for Operations, R&D, Materials, Facilities, Utilities, Equipment, Manufacturing, Labeling and Packaging, Laboratory Studies and Quality Control.
Doing RM Right Without Wasting Resources
Practical Aspects (Value) of Risk Management
Relationship with Other Quality Subsystems
Common Pitfalls and Misconception
How to Avoid Common Mistakes
Implementing RM in an Efficient and Effective Manner.
Speaker’s Practical PASS-IT Guide?
Who will benefit: (Titles)
CEOs
VPs
Compliance officers
Attorneys
Clinical affairs (associates, specialists, managers, directors or VPs)
Regulatory affairs (associates, specialists, managers, directors or VPs)
Quality assurance (associates, specialists, managers, directors or VPs)
R&D (engineers, scientists, managers, directors or VPs)
CROs
Consultants
Contractors/subcontractors
Webinar Includes:
Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
60 Minutes Live Presentation
Certificate of Attendance
Other CFPs
- Meet the New, Tougher FDA Expectations
- US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus
- 21 CFR Part 820 Quality System Regulation - Applying Principles of Lean Documents and Lean Configuration
- Patient Rights and the HIPAA Privacy Officer - Meeting Patient Desires and Avoiding Penalties
- Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs
Last modified: 2014-10-24 13:44:02