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Parenteral Drug Association Connecting People, Science and Regulation ®

Sterile Pharmaceutical Dosage Forms: Basic Principles

Mar 22 - Mar 23, 2018 |
Mar 23, 2018 |
Loews Sapphire Falls | Orlando, FL
  • Education
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Duration: 2 days
Time: 8:30 a.m. - 4:00 p.m.

Gain knowledge of the basic principles of sterile pharmaceutical dosage forms required to (1) improve processes by utilizing effective approaches to process validation and sterility assurance and (2) prepare for regulatory inspections based on current inspection trends for parenteral manufacturing. This introductory two-day course will address cleanroom design, environmental monitoring and control, sterilization principles, manufacturing unit operations, aseptic filling, dosage form development, packaging and stability requirements, validation of aseptic processing (media fills), product specific validation, QA/QC for parenterals, and regulatory trends.

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 compliance training.

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

  • Describe the basic principles of cleanroom facility design, environmental monitoring, and aseptic processing
  • Define the critical role of personnel in cleanroom operations
  • Recall the basic principles of sterilization, including an introduction to D, Z, and F values
  • Summarize the design and interpretation of media fills
  • Describe product specific validation for parenteral dosage forms
  • Discuss aspects of dosage form development, packaging, and stability
  • Describe the chemical composition of endotoxins, their toxic effects, sources, and testing procedures
  • Summarize the CGMP regulatory and inspection trends for parenteral manufacturing

Standard

Member

On or before February 5, 2018
$1,743

After February 5, 2018
$1,937

Nonmember

On or before February 5, 2018
$2,092

After February 5, 2018
$2,324


Government/Health Authority/Academic

Member

$1,162

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by February 20, 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.

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 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 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

This course will take place at:

Loews Sapphire Falls Resort
6601 Adventure Way
Orlando, FL 32819
Phone: +1 (407) 503-5000

Contact

For more information, please contact:

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

John Ludwig, PhD, Senior Vice President, Pfizer, Inc.

Sandeep Nema, Pfizer, Inc.

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 #352 | ACPE #0116-0000-17-028-L04-P | 1.2 CEUs
Type of Activity: Knowledge

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 12 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 12 PDHs.

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