Quality Systems for Aseptic Processing

Location: PDA Training and Research Institute, Bethesda, Maryland
Date: November 17-21, 2014
Duration: 5.0 days
Time: 8:00 a.m. - 5:00 p.m.

Program Highlights

What makes this course different?

  • Use of key faculty from the original PDA Aseptic Processing Training Program, including the two lead instructors from that course, provides continuity and unparalleled experience in Aseptic Processing and support systems. Collectively, the faculty has over 150 years’ experience in the industry and has demonstrated their ability to transfer their knowledge in the training setting.
  • Blend of theoretical knowledge in the lecture setting and the hands-on application of the theory in PDA’s clean room and microbiology laboratories provide the complete learning experience.
  • Aseptic processing and the systems which support it is a PDA core competency – for the instructors and the Association.

PDA has developed a new course in response to industry feedback and attendees of the Aseptic Processing Training Program.

This five-day comprehensive training program will give you and your personnel the tools necessary to optimize your Quality Systems associated with Aseptic Processing. Taught by leading industry experts with over 150 years of combined experience, this course includes almost 50% laboratory interaction to maximize performance.  Major topics to be covered include; Risk Management, Sterility by Design, troubleshooting and solving sterile filtration issues, investigations and CAPA, and how to effectively implement change within a structured regulated environment.

Who Should Attend

Manufacturing - Directors, Managers, Leaders, Supervisors, Technicians, Specialists
QA/QC - Directors, Managers, Technicians, Microbiologists and Specialists
Engineering - Directors, Managers, Technicians, Engineers and Specialists

Key Topics

  • Global regulatory compliance associated with recent citations
  • Risk Management for aseptic processing
  • Implementing change in a structured regulated environment
  • Current industry hot topics in aseptic processing
  • Investigations and case studies
  • Hands-on HEPA certification
  • Issues associated with sterile filtration
Upon completion of this course, you will be able to:
  • Evaluate and optimize current aseptic processing procedures at your facility
  • Design airflow visualization studies and their importance to risk management
  • Describe the concept of Sterility by Design
  • Develop the tools necessary to implement seamless change to a process
  • Troubleshoot filter integrity test failures
  • Evaluate and choose the appropriate microbial ID system for your facility
  • Integrate industry-approved disinfectant efficacy program to optimize contamination control in your facility
  • Outline the most common mistakes in the Steam in Place process
  • Interpret regulatory requirements for manufacturing sterile products produced by aseptic processing

What challenges/problems does this course identify and offer solutions to?

  • How to design and validate Aseptic Processing support systems such as:
    • HVAC systems - HEPA testing/certification, designing and executing air flow studies
    • Design and control of high purity water systems
    • Line and tank sterilization
    • Determination of environmental monitoring sites
  • Glass quality, particulate generation and visual inspection (currently an area of significant concern within the industry, resulting in Warning Letter citations and recalls.
  • Microbiological controls
    • Molds 
    • Microbiological identification methods and techniques
    • Disinfectant efficacy
  • Aseptically produced products represent a major challenge to ensure product quality and patient safety are not compromised. Regulatory agencies recognize this and give significant attention to aseptic processing operations during inspections. This course will include sessions on preparing for FDA inspections and understanding global regulatory requirements.
  • Other key topics which will be covered include:
    • Developing a vendor audit program
    • Change control 
    • Sterility by design
    • Hot topics in aseptic processing
    • Isolators and RABS
    • Issues in sterile filtration

What are the benefits of attending?

At the conclusion of this course, you will have:

  • Gained expanded, in-depth knowledge of key elements associated with the manufacture of aseptically produced products
  • Learned key elements associated with the design and operation of HVAC systems and applied those elements to the design of an environmental monitoring program for controlled environments
  • Obtained an awareness of potential problems and defects with glass containers, how those defects can impact product quality and be prevented and how to implement automated inspection systems to help ensure product quality
  • Determined the problem associated with molds in the pharmaceutical industry and how modern techniques and methods can help detect their presence
  • A greater understanding of how various global regulations apply to aseptic process manufacturing and how to prepare for regulatory inspections of these operations, such as those conducted by FDA
  • Developed an understanding of risk assessment and its application to aseptic processing, significantly reducing the potential for product quality problems

What makes this course different?

  • Use of key faculty from the original PDA Aseptic Processing Training Program, including the two lead faculty from that course, provides continuity and unparalled experience in Aseptic Processing and support systems. Collectively, the faculty has over 150 years' experience in the industry and have demonstrated their ability to transfer their knowledge in the training setting.
  • Blend of theoretical knowledge in the lecture setting and the hands-on application of the theory in PDA’s clean room and microbiology laboratories provides the complete learning experience.
  • Aseptic processing and the systems which support it is a PDA core competency – for the instructors and the Association.

David Matsuhiro, President, Cleanroom Compliance, Inc.
David Matsuhiro is the president of Cleanroom Compliance, Inc. Matsuhiro 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 (ASM) and The International Society of Pharmaceutical Engineers (ISPE). He received BS degrees in Microbiology and Chemical Engineering from San Jose State College.

Harold Baseman, Chief Operating Officer and Principal, ValSource LLC
Hal Baseman is Chief Operating Officer and a Principal at ValSource LLC, a 110 employee validation consulting and service firm. He has over 30 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 a member of the PDA Board of Directors, Co-Chair of the PDA Science Advisory Board, 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, and was Co-Chair of the PDA Risk Management Task Force responsible for writing Technical Report #44 on Quality Risk Management of Aseptic Processes. Most recently Hal co-chaired and led the PDA response to the FDA on draft Process Validation Guidance. Hal is a long time member of the PDA and its Training Research Institute faculty. He is a frequent 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.

Standard
Government / Health Authority / Academic
Member Non-Member Member Non-Member
Price on or before October 3, 2014 $5,050 $5,295 $3,300 $3,400
Price After October 3, 2014 $5,595 $5,895 $3,300 $3,400

All rates in US dollars.

Class Schedule

This course begins at 8:00 a.m. and ends at 5:00 p.m. unless otherwise noted on the confirmation letter or in course information posted on the website or in the course brochures. 

Please arrive at your course location approximately thirty minutes before the start of the course to register and receive your course materials. Please be sure to bring your confirmation letter as proof of registration during check-in. TRI 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

The course will be held at the PDA Training and Research Institute:

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 150
Bethesda, MD 20814
USA

Contact

For more information, please contact:

James Wamsley

Senior Manager, Laboratory Education
Tel: +1 (301) 656-5900 ext. 137
Email: wamsley@pda.org

ACPE The PDA Training and Research Institute is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Education Units (CEUs) following the successful completion of an accredited course and submission of the provided evaluation forms. Statements of Credit for CEUs earned will be mailed within four to six weeks of the event.

PDA #433| ACPE #0116-0000-11-433-L04-P 3.0 CEUs
Type of Activity: Application

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