Management of Aseptic Processing

Location: PDA Training and Research Institute, Bethesda, Maryland
Date: October 6-8, 2014
Duration: 3 days
Time: 8:30 a.m. - 4:00 p.m.

Description

International regulatory authorities are placing a heavy emphasis on aseptic processing, and it’s difficult to keep pace with what their expectations really are. Are you sure you know what ‘current’ Good Aseptic Practices are? Are you making sound decisions about your aseptic operation? PDA Training and Research Institute is announcing its newest course in the area of Aseptic Processing – Management of Aseptic Processing. This course will arm managers with the tools they need to make informed business decisions related to aseptically produced products, including selection of aseptic processing technologies, and sourcing decisions.

The instructors in this course will provide you with insight into current inspection trends so you can keep up with the moving target of cGMP. You’ll come away with an understanding of the spectrum of aseptic process designs and operations, and different risk management strategies that should be employed for the most effective cost benefit result. You’ll learn the science behind airflow, aseptic technique, human factors, personnel qualification and tools like smoke studies, media fills and risk assessments.

Do you have the right people in your organization? The right culture? How are you going to recognize the need for, implement, and manage changes within your organization? The course will provide you with the knowledge needed to evaluate investigations, and make informed, risk-based decisions regarding product disposition.

Make sure you and your company remain on the positive side of current and anticipated expectations in the industry by ensuring high quality products through sound scientific practices, good decision making, and an efficient and effective team.

Who Should Attend

This course is intended for professionals associated with  the management of aseptic manufacturing operations, QA/QC, product and process development, regulatory affairs, sterility assurance, technical operations and validation.

Upon completion of this course you will be able to:

  • Analyze current regulatory inspection trends and risk mitigation
  • Understand the impact of quality culture and your organizational structure and processes to identify potential gaps in personnel or procedures
  • Identify why aseptic processes are designed and operated in a certain way
  • Evaluate facility and equipment alternatives and associated risks
  • Define your company’s responsibility to its customers, namely the patients, and how to meet that responsibility and protect your company from the business risks associated with non-compliance and process failures
  • Develop an effective problem solving and decision making strategy for multiple functional areas within your company

John Shabushnig, PhD, Insight Pharma Consulting, Inc.

Harold Baseman, ValSource, LLC

Standard
Government / Health Authority / Academic
Member Non-Member Member Non-Member
Price on or before August 22, 2014 $2,155 $2,515 $1,375 $1,475
Price After August 22, 2014 $2,395 $2,795 $1,375 $1,475

All rates in US dollars.

Class Schedule

All lab courses begin at 8:30 a.m. and end at 4:00 p.m. unless otherwise noted on the confirmation letter or in course information posted on the website or in the course brochures. Courses that are listed with a half day will begin at 8:30 a.m. and end at noon on the last day.

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 8:00 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.

Location

The course will be held at the PDA Training and Research Institute:

PDA Training and Research Institute
4350 East West Highway, Suite 150
Bethesda, MD 20814

Contact

For more information, please contact:

James Wamsley
Senior Manager, Laboratory Education
Tel: +1 (301) 656-5900 ext. 137

Email: wamsley@pda.org

ACPE 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.

PDA #380 | ACPE #0116-0000-13-380-L04-P | 1.8 CEUs
Type of Activity: Application

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