Course Description

An interactive course including workshop which will utilize the PDA Technical Report No. 44 Quality Risk Management of Aseptic Processes methodology to identify, assess, manage, and use risk to make informed decisions in aseptic processing. Course will include background information in quality risk management, regulatory expectations, unique aspects of risk management related to aseptic processing of sterile products, organizational culture, risk assessment methods and examples, use of risk in process validation, and practical exercises to assess risk.

Who Should Attend

Managers and direct execution staff responsible for design, planning, qualification, validation, operation, testing and investigation of aseptic processes and sterile products manufactured by aseptic processing will benefit from this course.

Learning Objectives

Upon completion of this course, you will be able to:

• Discuss use of risk assessment techniques to identify and rank relative quality risk that is related to aseptic processes, benefits and use of quality risk management, unique aspects of quality risk management related to aseptic processing, regulatory expectations and rationale for use of quality risk management for aseptic processes.
• Identify aseptic process steps and conditions which can adversely affect sterility and quality of sterile product; and ways to mitigate risk and improve process
• Analyze levels and ranking of relative risk in aseptic processing steps and conditions

Instructor

Harold Baseman, Principal, ValSource, LLC

Class Schedule

Please arrive at your course location approximately thirty minutes before the start of the course to register and receive your course materials. Please be sure to bring your confirmation letter as proof of registration during check-in. TRI will not allow persons to attend a course without payment, or guarantee of payment.

A continental breakfast will be served before class beginning 7:30 a.m. Lunch will be provided from 12:00 – 1:00 p.m. Snacks will be provided during the morning break from 10:00 – 10:15 a.m. and the afternoon break from 2:30 – 2:45 p.m.

Continuing Education Credits

The PDA Training and Research Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Education Units (CEUs) following the successful completion of an accredited course and submission of the provided evaluation forms. Statements of Credit for CEUs earned will be mailed within four to six weeks of the event.

Registration Fees

Member/Nonmembers Standard	$1295
Student/Academic/Government	$780

Rates in US dollars.

Location/Lodging Information

GRAND HYATT DENVER
1750 Welton Street
Denver, Colorado, USA 80202
Tel: +1 303 295 1234