Skip To The Main Content
Parenteral Drug Association Connecting People, Science and Regulation ®

Filtration Processes in the Pharmaceutical and Biopharmaceutical Industry

Sep 25 - Sep 28, 2017 |
Sep 28, 2017 |
PDA Training and Research Institute | Bethesda, MD
  • Education
Add event to: ICal Outlook Google Calendar
Duration: 4 days
Time: 8:30 a.m. - 4:00 p.m.

In-depth knowledge is required to run optimal filtration processes and appropriate integrity tests. The filter can be a protective unit to prolong the life of other equipment, to reduce the amount of bioburden, or act as the critical barrier before the product reaches the vial. If an integrity test fails, the end-user needs to determine why the filter failed and what corrective actions should be taken.

This interactive training addresses the following topics:

  • Design, construction and manufacturing of pre-, depth and membrane filters
  • Contaminant retention mechanisms for liquid and gas filtration including sieve retention and adsorptive sequestration
  • Pre-/Post-use integrity testing using diffusional airflow, bubble point, pressure-hold and water intrusion test
  • Process validation requirements for microorganism challenges, extractables and testing parameters
  • Troubleshooting integrity test and filtration process design issues

Who Should Attend

This course is intended for professionals who design and perform filtration processes. Typical areas and roles include the following:

  • Manufacturing - Operator/Technician
  • Quality Assurance - Supervisor/Manager
  • Quality Control - Supervisor/Manager
  • Process Development - Specialist/Scientist
  • Engineering - Process Engineer/Reliability Engineer
  • Validation - Specialist

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

  • Apply knowledge of filter properties to select the appropriate filter for a specific process
  • Design and select different integrity test methods
  • Differentiate and optimize pre-filter and final filter arrangements
  • Identify filterability and scalability requirements for filtration optimization
  • Describe validation and process performance qualification requirements
  • Resolve integrity test failures and troubleshoot filtration process issues

Standard

Member

On or Before August 11, 2017
$4,219

After August 11, 2017
$4,699

Nonmember

On or Before August 11, 2017
$5,075

After August 11, 2017
$5,639


Government/Health Authority/Academic

$2,819

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by August 25, 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

Maik Jornitz, President, G-CON Manufacturing Inc.; Principal, Bioprocess Resources LLC

Maik W. Jornitz, President of G-CON Manufacturing Inc. and Principal of Bioprocess Resources LLC, is a distinguished technical expert with close to 30 years of experience in bioprocesses, especially sterilizing grade filtration and single-use technologies, including regulatory requirements, integrity testing, systems design, and optimization. Jornitz has published 10 books, 15 book chapters, over 100 scientific papers and trains industry and regulators on a frequent basis. He is Vice Chair of the PDA Science Advisory Board, recipient of the PDA Agalloco Award for excellence in education and Martin Van Trieste Award for contributions to pharmaceutical science. Furthermore, he is an advisory board member of the Biotechnology Industry Council and multiple scientific journals. He received his M.Eng. in Bioengineering at the University of Applied Sciences in Hamburg, Germany and accomplished the PED program at IMD Business School in Lausanne, Switzerland.


Wayne Garafola, Application Specialist, Sartorius-Stedim Biotech

Mr. Garafola received special training and work experience in membrane filtration technologies, integrity testing, pre-filtration and sterilizing filters, Cross flow separations, membrane adsorber (chromatographic) separations, Utility IQ/OQ (air/gas/water/steam), and various filtration applications. He completed a Bachelor of Science degree in Microbiology at Pennsylvania State University. He has over 25 years experience in the pharmaceutical and life science industries, working in a variety of positions from QA, R&D, Validation Services, and Technical Services. Shared the 2016 James P. Agalloco Award for PDA TRI faculty member who exemplifies outstanding performance in education with co-teacher, Maik W. Jornitz. A member of PDA (Parenteral Drug Association) for 20 years, teaching at PDA Training Research Institute since 2006.

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 #514 | ACPE #0116-0000-16-038-L04-P | 2.4 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 24 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 24 PDHs.

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=3536

Directions