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PDA #100 Aseptic Processing Option 5 - Sold Out

Oct 09 - Nov 10, 2017 |
Nov 10, 2017 |
PDA Training and Research Institute | Bethesda, MD
  • Education
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Week 1 Dates: Oct 09 - Oct 13, 2017
Week 2 Dates: Nov 06 - Nov 10, 2017

This two-week comprehensive course, taught by numerous industry leading experts in their fields with more than 300 years of combined experience, will give you the training and information needed to properly evaluate and improve your aseptic processes to ensure sterile products.

Key Topics

Week 1

  • Definition and scope of aseptic processing
  • Facility design
  • Velocity and airflow studies
  • Basic microbiology
  • Filtration and liquid filter integrity testing
  • Aseptic process simulations (media fills)
  • Environmental monitoring and control systems
  • Sanitization techniques and sterilization qualification
  • Gowning, personnel and aseptic technique qualification
  • Lyophilization
  • EU/US Regulations

Week 2

  • Reading and evaluating media fills
  • Good documentation practices
  • New process and facility technology
  • Environmental data trending and excursion analysis
  • Moist heat sterilization
  • Rapid microbial identifications
  • Industry hot topics
  • Isolators/Bio-decontamination
  • Endotoxins and LAL testing
  • Sterility Testing
  • Liquid Particle Testing

Who Should Attend

This course is intended for professionals who are involved in sterile manufacturing. 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:

  • Demonstrate an increased proficiency of techniques and skills relating to aseptic processing
  • Evaluate and improve current aseptic processing procedures at your facility
  • Limit risk for manual product contamination with airflow visualization studies
  • Evaluate your environmental monitoring program to collect appropriate data, identify and interpret trends
  • Incorporate proper gowning principles into a complete personnel qualification program
  • Describe the importance of filter integrity testing when filtering water, gases or proteinaceous solutions
  • Develop robust media fill protocols including appropriate interventions, observation and documentation procedures
  • Discuss finished product testing requirements
  • Correlate basic microbiology concepts and techniques to multiple aspects of aseptic processing
  • Integrate industry-approved sanitization techniques and disinfectant evaluation into a comprehensive contamination control program
  • Interpret regulatory requirements for manufacturing sterile products produced by aseptic processing

Standard

Member

$9,595

Nonmember

$9,979


Government/Health Authority/Academic

$5,757

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by August 10, 2017, you will receive a full refund less a $500 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

This course begins at 8:00 a.m. and ends at 6:30 p.m., Monday through Thursday. The course attendees will be released at 12:30 p.m. on Friday during Week 1, and at 1:15 p.m. on Friday during Week 2.

Please arrive at the PDA Training and Research Institute 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 7:30 a.m. Lunch will be provided from approximately 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

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

David Matsuhiro, Cleanroom Compliance, Inc.

David Matsuhiro is the principal for Cleanroom Compliance, Inc. He has worked as a consultant for Aseptic Solutions and KMI Systems, specializing in water, environmental systems and aseptic processing. He has also worked for Genentech, Inc. in a variety of environmental control positions. Matsuhiro is a member of several professional associations, including PDA, the American Society of Microbiology and the International Society of Pharmaceutical Engineers. He received BS degrees in Microbiology and Chemical Engineering from San Jose State College.


Hal Baseman, Chief Operating Officer and Principal, ValSource LLC

Hal Baseman is Chief Operating Officer and a Principal at ValSource LLC, a 250 employee validation consulting and service firm. He has over 38 years of experience in pharmaceutical operations, validation and regulatory compliance. Hal has held positions in executive management and technical operations at several drug manufacturing and consulting firms. Hal is the immediate past chair of the PDA Board of Directors, former Co-Chair of the PDA Science Advisory Board, former Co-Leader of the PDA Validation Interest Group, Co-Chair of the PDA Aseptic Process Simulation Technical Report #22 Task Force on Aseptic Process Simulation, Co-Chair of the PDA Risk Management Technical Report #44 on Quality Risk Management of Aseptic Processes. Co-Leader of the PDA Aseptic Processing Points to Consider. Hal is a long time member of the PDA and its Training Research Institute faculty. He is a frequent instructor and presenter on subjects related to Quality Risk Management, Validation, and Aseptic Processing. Hal holds an MBA in Management from LaSalle University and a B.S. in Biology from Ursinus College.

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 #100 | ACPE #0116-0000-15-030-L04-P | 8 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 80 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 80 PDHs.

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