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Airflow Visualization Techniques and Practices - August

Aug 15 - Aug 17, 2017 |
Aug 17, 2017 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Duration: 3 days
Time: 8:30 a.m. - 4:00 p.m.

Airflow visualization studies are used to observe air movement, which can reduce the risk to the process and/or product. The results from these studies can be used to develop and/or enhance filling operations to ensure global regulatory requirements are met. They can also be used as a training tool for personnel, as well as define the sanitization procedures and environmental monitoring process within the aseptic filling areas.

In this course, participants will discuss the components required in an airflow visualization study, to include:

  • Protocol design
  • Static, dynamic and as built conditions
  • Fill equipment set-up
  • Intervention execution
  • Personnel movements
  • Air return balancing
  • Protocol acceptance criteria

Participants will also learn about the regulatory requirements, facility design elements, HEPA filter operations and fill room air return designs. The key element to the airflow study is the concept of “First Air” and its relationship to product sterility and risk reduction. Participants will learn how to incorporate these elements into a contamination control program emphasizing good aseptic technique and cleanroom behavior.

Participants will get the opportunity to execute both static and dynamic airflow studies, film the process, critique the video and assess their results. They will also learn how to visually document their study in a way that allows the viewer to clearly understand the process based on the risk and “First Air” concept.

Who Should Attend

Department: Engineering, Manufacturing, Microbiology, Quality, Training, Validation

Job Function: Auditors, Directors, Managers, Leaders, Supervisors, Engineers, Site Head, Plant Manager, Qualified Person

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

  • Identify all necessary equipment, processes and interventions that should be included in an airflow visualization study
  • Develop a protocol to execute a comprehensive airflow visualization study
  • Identify appropriate equipment to be utilized to generate smoke and document the airflow visualization study
  • Evaluate current facility for appropriate design and identify areas for process improvement
  • Discuss regulatory requirements related to airflow visualization studies
  • Implement a new training program to improve clean room personnel technique and behavior
  • Solve problems associated with airflow visualization studies in barrier filling systems, such as RABS and isolators

Standard

Member

On or Before June 30, 2017
$3,319

After June 30, 2017
$3,699

Nonmember

On or Before June 30, 2017
$3,995

After June 30, 2017
$4,439


Government/Health Authority/Academic

$2,219

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by July 17, 2017, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at info@pda.org or +1 (301) 656-5900.

General Course Information

Please arrive at the course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA 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 between 12:00 - 1:00 p.m. Snacks will be provided during breaks throughout the day.

Location

The course will be held at:

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

Recommended Hotel

Hilton Garden Inn Bethesda
7301 Waverly Street | Bethesda, MD 20814 | 0.3 miles from PDA
(301) 654-8111

Contact

For more information, please contact:

Kimberly McIntire
Assistant Manager, Laboratory Operations
Tel: +1 (301) 656-5900 x103
Email: mcintire@pda.org

David Matsuhiro, Cleanroom Compliance, Inc.
David Matsuhiro is the principal for Cleanroom Compliance, Inc. He has worked as a consultant for Aseptic Solutions and KMI Systems, specializing in water, environmental systems and aseptic processing. He has also worked for Genentech, Inc. in a variety of environmental control positions. Matsuhiro is a member of several professional associations, including PDA, the American Society of Microbiology and the International Society of Pharmaceutical Engineers. He received BS degrees in Microbiology and Chemical Engineering from San Jose State College.

Continuing Education for Pharmacists

ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

PDA #802 | ACPE #0116-0000-16-037-L04-P | 1.8 CEUs
Type of Activity: Application

Continuing Education for Professional Engineers

New Jersey

PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

The credit value of this course is 18 CPC credits.

North Carolina

PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

The credit value of this course is 18 PDHs.

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