Overview

August 5, 2020, 8:00 am to 5:00 pm
Avedisian Hall, 7 Greenhouse Road, Kingston, RI 02881

This course introduces biopharmaceutical personnel to best practices, regulatory expectations and industry trends in the disciplines of facility cleaning, validation and environmental monitoring (EM). Instruction and hands-on laboratory work focus on essential industry guidance protocols that govern the effectiveness of cleaning procedures. Course materials cover facility cleaning methodologies, EM and validation procedures and include extensive hands-on exercises using PDI’s state-of-the art cGMP facility. Additionally, environmental monitoring theories and methods are implemented in order to validate cleaning processes in order to ensure that participants understand and are capable of implementing the actions needed to achieve industry standards.

Who should attend this course?

Individuals working in the Biomanufacturing industry including roles such as Quality Assurance, Regulatory, Quality Control, Validation, Operations, Microbiology, Facilities Maintenance, Engineering, and Plant Management disciplines.

Objectives

• Gain practical knowledge and training in the areas of facilities cleaning, CIP, SIP and EM
• Learn how to effectively clean and sanitize biopharmaceutical manufacturing areas with understanding of environmental testing protocols and validation requirements
• Integrate the disciplines of Quality Assurance, Quality Control, Microbiology, Operations and Facilties Management

 How are the workshops run?

Courses are delivered through a combination of classroom presentations and hands on activities. The hands on activities take place in a clean gowned environment in our own GMP facility. This course is limited to a maximum of 15 participants.

What are the key benefits?

   

• This course is designed for biopharmaceutical manufacturers who need to develop and maintain high-quality, efficient, and compliant cleaning processes.
• Participants will be educated in the processes of cleaning and validation and will be prepared to work within their respective companies in accordance with standards and regulations that govern biopharmaceutical manufacturing.

Program Faculty

Registration & Fees

The workshop runs from 8 am to 5 pm. Registration includes program materials, refreshments and lunch.

Refunds

Registration fee, subject to a $200 processing charge, will be refunded provided written notification of registration cancellation is received 14 days prior to the start date of the training.

Payment

Payment via Visa, Master Card, Discover Card, or American Express can be made upon completion of the online registration process. Electronic checks are also accepted. No payments or registrations will be accepted by phone.

Fees

Individual participant $1,000