Change Management - Managing Effective Change and Eliminating Unwanted Changes

Why Should You Attend:

All companies need a change management system, but very few have systems that are effective in implementing change in a timely manner. Due to inefficiencies and lack of effectiveness, companies frequently find their employees circumventing processes, systems overwhelmed and changes implemented without assessing their effectiveness or ensuring unwanted deleterious effects are introduced.

This webinar will present the requirements for effective change management, typical problems with ineffective change management and proactive steps companies can take to eliminate unwanted changes.

Areas Covered in the Webinar:

• Change – Definitions
• Change Management
• Regulatory Requirements
• FDA
• ICH
• EU
• Typical Problems with Change Management Systems
• Effective Management of Change
• Robust Integrated QMS
• Management
• Eliminating Unwanted Change
• Design Space
• Culture
• Metrics

Who Will Benefit:

• Quality Assurance Management
• Regulatory Affairs
• Production Management
• Practitioners of Change Implementation

From Regulated industries – Pharma, Bio-pharma, Medical Device – all aspects from clinical to commercial.

Free Materials:

• SOP with assessment template

David Husman
President and Principal Consultant, David Husman Consulting LLC

Over 30 years of diverse international industry experience in Quality Assurance, Quality Control and Regulatory Affairs. Last 18 years as a consultant to biopharma, pharma and device industries.

Experience has spanned from R&D to Commercial Manufacture

Background includes, but not limited to, parenteral products, human tissue products, blood products, biotech products, solid dosage, vaccines, implantable devices, and in vitro diagnostic products for both human and animal species.

Extensive experience in laboratory operations including but not limited to auditing, development of laboratory system procedures, implementation of laboratory at a new site and forensic data integrity investigations.

Experience in all parts of the manufacturing operation from warehousing to packaging, from facilities and utilities to laboratories to computer systems, from regulatory to quality control.

Expert level in Compliance and Quality System development.

Executed numerous Data Integrity assessments and remediation projects worldwide.

Ph.D. in Biochemistry, Certified as a GMP expert and in Regulatory Affairs.

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