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Parenteral Drug Association Connecting People, Science and Regulation ®

The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology - New Course

Oct 12 - Oct 12, 2018 |
Oct 12, 2018 |
Loews Royal Pacific Resort | Orlando, FL
  • Education
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Duration: 1 day
Time: 8:30 a.m. - 4:00 p.m.

This course is designed to provide and evaluate recommendations specific to the operation of Blow-Fill-Seal technology for the manufacture of sterile pharmaceuticals; e.g., injectable, ophthalmic, parenteral, and inhalation drugs and medical devices. Supplemental information to assist users with interpretation of international standards and regulatory guidance regarding BFS operations will also be provided.

Who Should Attend

This course is designed to provide a broad overview for individuals working in sterile formulation/process development, sterile manufacturing, QA/QC, microbiology, environmental monitoring, package engineering, and aseptic fill and finish.

Prerequisites

Basic knowledge of aseptic fill/finish packaging, cGMP and regulatory requirements is desired.

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

  • Describe the recommended requirements necessary to utilize blow-fill-seal (BFS) fill/finish technology
  • Assess if BFS technology can be applied to new or existing pharma products
  • Describe the basic principles of BFS: cleanroom facility design, environmental monitoring, and aseptic processing
  • Explain the process of evaluating product contact materials, extractable profiles and leachable risk
  • Evaluate the aseptic risk of BFS in comparison to other advanced aseptic fill/finish operations: isolators and closed RABS systems
  • Identify the specific qualification and validation aspects for BFS

Standard

Member

On or before August 27, 2018
$1,192

After August 27, 2018
$1,325

Nonmember

On or before August 27, 2018
$1,431

After August 27, 2018
$1,590


Government/Health Authority/Academic

Member

$795

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by September 11, 2018, 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.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.

Location

The course will be held at:

Loews Royal Pacific Resort
6300 Hollywood Way
Orlando, Florida 32819

Contact

For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: ko@pda.org

Dr. Martin Haerer, Rommelag

Dr. Haerer graduated in 1986 from the University in Tübingen with a degree in Pharmacy. His doctorate was completed in 1990 (summa cum laude) with a thesis written about Analytical Chemical Pharmaceutical Processes. A Master Degree in Pharmaceutical Technology was also given. After 1990 he began a carrier in the pharmaceutical industry with Rommelag CMO working in different area: Production, Quality Control and Quality Assurance. Rommelag CMO is a company that specializes in aseptic Blow Fill Seal manufacturing with various regulatory approvals (e.g. FDA, EMEA, Brazil, and Japan). In 2006 he has worked as Production Manager and Qualified Person (QP) for all the companies manufacturing sites. Recently he became responsible for Business Development, Technology Transfer and Research and while still acting as Qualified Person with QA responsibilities.

Dr. Haerer was the Task Force Leader for the PDA Technical Report 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology, Board Member (regulatory officer) for the Blow/Fill/Seal International Operators Association (BFSIOA), Member of the German QP Association, Board Member of Federal German Pharmacist Advanced Training Organization (BAK).

Tim Kram, General Manager, Rommelag

Mr. Kram is an Engineer and pharmaceutical business development professional, and is presently the General Manager for Rommelag Engineering’s US office. For the past 15 years he has provided aseptic product fill/finish solutions using Blow/Fill/Seal technology. This work includes container development, clinical trials, regulatory filings, combination device development, primary drug packaging, machine sizing, validation/qualification, and commercial/contract manufacturing. For ten years he has worked to introduce temperature sensitive biotech and vaccine products to BFS technology, and has received two foundation grants for the testing of injectable vaccines with BFS technology and CPAD device development. Mr. Kram regularly consults and gives presentations to BFS operators, industry groups and regulatory organizations. In the past Mr. Kram has worked as a process engineer, filtration specialist, project manager and service engineer. He received a B.S. in Electrical Engineering from the Missouri University of Science and Technology in 1991.

Mr. Kram is an active member in the PDA, task force member Technical Report 77: The Manufacture of Sterile Pharmaceutical Products Using Blow-Fill-Seal Technology, task force member Technical Report 27 update: Pharmaceutical Package Integrity, ISPE member, AAPS member.

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 #539 | ACPE #0116-0000-18-007-L04-P | 0.6 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 6 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 6 PDHs.

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