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Fundamentals of Aseptic Processing - Option 1

Feb 11 - Feb 14, 2019 |
Feb 14, 2019 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Duration: 4 days
Time: 8:30 a.m. - 4:30 p.m.

This interactive course will provide individuals with an understanding of the principles, processes and systems related to aseptic operations.

Topics to be addressed include:

  • Facility/Equipment/Process Design
  • Environmental Monitoring
  • Airflow Studies
  • Aseptic Gowning
  • Disinfectant Efficacy
  • Sanitization Techniques
  • Filtration Processes
  • Moist Heat Sterilization
  • Aseptic Process Simulations (Media Fills)
  • Reading and Evaluating Microbial Results
  • Visual Inspection

Who Should Attend

This course is intended for professionals new to the pharmaceutical industry and/or to aseptic processing. Typical areas and roles include the following:

  • Manufacturing - Director/Manager/Supervisor/Operator/Technician
  • Quality Assurance - Director/Manager/Supervisor/Specialist
  • Quality Control - Director/Manager/Supervisor/Analyst
  • Engineering - Manager/Supervisor/Technician/Engineer

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

  • Evaluate current aseptic processing procedures
  • Assess potential risks of product contamination using airflow visualization techniques
  • Determine the necessary components of an effective environmental monitoring program
  • Describe the importance of filter integrity testing
  • Examine the media fill operation to ensure appropriate interventions and observations occur
  • Discuss finished product testing requirements
  • Correlate basic microbiology concepts and techniques to multiple aspects of aseptic processing
  • Demonstrate an understanding of sanitization techniques and disinfectant evaluation by properly operating different cleaning systems
  • Interpret regulatory requirements for manufacturing sterile products produced by aseptic processing

Standard

Member

On or Before December 28, 2018
$4,409

After December 28, 2018
$4,899

Nonmember

On or Before December 28, 2018
$5,291

After December 28, 2018
$5,879


Government/Health Authority/Academic*

$2,939

*For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Special Accommodations and Dietary Requirements
If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact registration@pda.org or +1 (301) 656-5900. SUBSTITUTION: If a substitution request is sent by January 12, 2019, no fee will be charged. After January 12, 2019, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee. REFUND: If a refund request is sent by January 12, 2019, a full refund will be given minus a $200 fee. After January 12, 2019, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

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:

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 110
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
Manager, Education
Tel: +1 (301) 656-5900 x103
Email: mcintire@pda.org

Mary W. Carver, Senior Consultant, Pharma Microbiology Consulting, LLC

Ms. Carver is a Senior Consultant and founder of Pharma Microbiology Consulting, LLC, where she specializes in pharmaceutical microbiology and aseptic processing. She has over 26 years of experience in the pharmaceutical/medical device industries. Work experience includes microbiology, aseptic processing, quality assurance/quality control, environmental monitoring, validation, sterilization, microscopy, and clinical product development/manufacturing support. She has managed microbiology laboratories for various well known organizations. In her last industry position, she was Associate Director Microbiology for Eisai Inc. in Research Triangle Park, NC, where she was responsible for supporting aseptic manufacturing lines and oral solid dose manufacturing as well as development of clinical drug products. She has started-up of two Microbiology Laboratories, supported validation of two newly constructed isolator lines, and designed and implemented environmental monitoring programs intended to satisfy worldwide regulatory requirements. Over the past five years as a consultant, Ms. Carver has provided training in microbiology and aseptic processing, performed GMP audits, and consulted on sterilization and microbial testing issues. She holds a B.A. in Bacteriology from DePauw University in Greencastle, Indiana. Ms. Carver has been a member of PDA since 1991 and is a former president of the PDA Southeast Chapter.


John Lyons, Sr. Process Engineer, Integrated Project Services (IPS)

John Lyons is a pharmaceutical manufacturing professional specializing in aseptic processing. He is currently a Sr. Process Engineer at Integrated Project Services (IPS). Previous positions include Senior Engineer and Partner at Sterile Technology as well as Deputy Director of Operations for OncoGenerix's parenteral manufacturing facility in Mudanjiang China. At OncoGenerix, his responsibilities include coordination and oversight of manufacturing, engineering and administration departments to facilitate operational objectives; as well as interfacing with Quality Operations to ensure compliance with internal QMS and global regulatory requirements.

As a senior engineer, John's project experience includes the complete lifecycle approach from project conceptualization, design, construction, start-up and qualification through into operation. His specialist areas include barrier isolator systems, sterilization (H2O2, steam & dry heat), sterile component handling, sterile filling of vials & syringes, lyophilization & loading systems, commissioning and qualification, and the containment of APIs and potent compounds. He holds a B.S. in Computer Engineering from the University of Scranton.

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 #800 | ACPE #0116-0000-16-039-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.

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