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Pharmaceutical Manufacturing Equipment Qualification and Maintenance

Tuesday, 29 October 2019 10:00 AM PDT | 01:00 PM EDT

Training Duration = 60 min               Sponsored by ComplianceOnline

Click Here to register $229.00

Click Here to register and receive CD recording $399.00

Attend this webinar to learn about the GMP requirements for pharmaceutical equipment. Regulations require that equipment is to be of appropriate design, constructed not to alter the product, and properly cleaned and maintained.

Demonstrating the adequacy of the equipment starts with a risk assessment and a design qualification and continues through installation qualification, operational qualification, performance qualification and process validation. Preventive and corrective maintenance provide assurance that the equipment will continue to operate as intended.

Why Should You Attend:

It is always challenging to manage qualification of equipment in a pharmaceutical manufacturing environment. It is also demanding to know how to document changes and maintenance activities.

In this webinar, you will learn how to base your equipment qualification and maintenance program on a risk management plan and to appropriately document all of the equipment-related activities. Using this risk-based approach, you can streamline the process of addressing equipment failures and managing process changes. You will learn strategies for avoiding common pitfalls and for lifecycle management of manufacturing equipment.

This webinar will provide a risk-based approach from the beginning stages of planning and acquisition of pharmaceutical manufacturing equipment through ongoing usage of the equipment. Planning for and documenting the activities will be discussed.

The topic will include the validation master plan, risk assessment, design qualification, installation qualification, operational qualification, performance qualification and the impact of equipment on process validation.

Additionally, an understanding of the requirements for preventive and corrective maintenance will be included. You will learn how to set up a preventive maintenance schedule based on risk and when to adjust the schedule to ensure the plan remains suitable.

Areas Covered in the Webinar:

  • The importance of risk management for manufacturing equipment
  • Validation Master Plans
  • Planning for new equipment, commissioning, and completing the design qualification
  • Installation Qualification
  • Operational Qualification
  • Performance Qualification
  • Process Validation
  • Planning for equipment maintenance
  • Documenting equipment maintenance
  • The connection with change control
  • When to revise your equipment maintenance plan

Instructor Profile:

Peggy Kwoka has more than thirty years of experience in pharmaceutical, cosmetic consumer health and medical device industries including twenty years in Quality Assurance management and consulting. She has managed or provided expertise for more than ten US FDA inspections.

Peggy is currently working with pharmaceutical companies to develop effective quality systems through her consulting firm, Quality GMP Solutions, LLC. She focuses on improving her client’s manufacturing and quality processes to enhance their regulatory compliance profile. She previously held quality assurance management roles at Colgate-Palmolive Company and GlaxoSmithKline.