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Parenteral Drug Association Connecting People, Science and Regulation ®

Regulatory Aspects of Microbiology in a Non-Sterile Environment

Oct 19 - Oct 19, 2017 |
Oct 19, 2017 |
Bethesda North Marriott Hotel & Conference Center | Bethesda, MD
  • Education
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Duration:  1 day
Time: 8:30 a.m. - 4:00 p.m.

This course is designed to assist participants in determining when they are in regulatory compliance within a non-sterile environment. Non-sterile microbiology offers many challenging regulatory issues often not considered in aseptic manufacturing because the rules are minimal in comparison; these include handling and evaluation of non-sterile components, the environment and final product. This course discusses various regulations and how they impact non-sterile manufacturing, such as the setting of specification, development of processes, holding times, preservation issues, cleaning, sanitization and the requirements for the testing of recovered microorganisms. Thoughts regarding in-house microorganisms that may be considered as “specified” will also be discussed. A case study will be included where teams will discuss some of the various regulatory issues that are encountered in a plant environment and report their findings to all of the participants.

Who Should Attend

This course is intended for individuals in the manufacturing of pharmaceuticals, cosmetic products, as well as dietary substances that are not labeled as sterile. Sufficient background information will be provided to enable participants with minimal science background to benefit. Individuals in quality assurance/quality control, regulatory compliance, manufacturing, research & development, technology transfer and project management will benefit from this course.

Prerequisites

Individuals will benefit having a basic background in the sciences including biology (microbiology) or chemistry, and having basic familiarity with various regulations to include: 21 CFR 211, FDA Guidance documents, EMA and Health Canada guidance and/or ICH Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients – ICH Harmonized Tripartite Guideline, November 2000.

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

  • Identify microbiological regulatory concerns with non-sterile incoming components, in-process, active pharmaceutical ingredients (API) and finished product
  • Discuss key microbiological issues involved in the manufacturing of non-sterile products
  • Review the establishment of a non-sterile microbiological control program
  • Identify gaps with current regulatory and industry expectations
  • Explain how USP<1115>, Bioburden Control of Non-Sterile Drug Substances and Products, complements the development of non-sterile products

Standard

Member

On or before September 4, 2017
$1,169

After September 4, 2017
$1,299

Nonmember

On or before September 4, 2017
$1,403

After September 4, 2017
$1,559


Government/Health Authority/Academic

Member

$779

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by September 19, 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.

Class Schedule

All 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:

Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road
North Bethesda, MD 20852 USA
Phone: +1 (301) 822-9200

Contact

For more information, please contact:

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

Barry Friedman, PhD, Consultant, Barry A. Friedman, PhD, LLC

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 #221 | ACPE #0116-0000-14-031-L04-P | 0.6 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 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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