Available Courses:

• Integration of Risk Management in Quality Systems
  May 4
  Risk Management has emerged in regulated industry as a recognized and accepted method of prioritizing and focusing activities and resources on quality issues that represent the greatest risk to the end user. This workshop will focus on methods to imbed risk management concepts into elements of the quality systems and utilize current quality data to develop a closed-loop and “living” risk management program.
  
  
• Producing In-house Training Videos – When “Off the Shelf” Just Won’t Do
  May 4
  Today’s technology allows the average trainer to be a video producer. Many times, an “off the shelf” video doesn’t meet your needs; it’s either too generic or doesn’t cover all the information you want. You will be shown how to take your idea and turn it into a compelling video when “off the shelf” just won’t do. Using their own in-house videos as examples, the instructors will guide the participants on the do’s and don’t of in-house video production. The course will be part lecture but primarily in the form of a hands-on workshop.
  
  
• Basic Concepts in Cleaning and Cleaning Validation
  May 4 - 5
  This course covers the basic concepts in critical cleaning processes in pharmaceutical manufacturing in addition to the validation of those cleaning processes. It is designed to cover the fundamentals of cleaning processes, including cleaning agents, cleaning methods, and cleaning process parameters, as well as the regulatory expectations and current practices of cleaning within the framework of validation expectations. This course is primarily in lecture format, with hands-on, small-group exercises and other opportunities for class interaction.
  
  
• Sterile Pharmaceutical Dosage Forms: Basic Principles
  May 4 - 6
  This is an introductory two-day course on sterile dosage forms. It is designed to provide a broad overview for individuals working in sterile manufacturing, QA/QC, microbiology, formulation development, package engineering, and compliance training. One hour each day will be devoted to a participatory problem solving exercise and discussion.
  
  
• Corrective and Preventative Action (CAPA)
  May 5 - 6
  CAPA is designed to meet the requirements mandated by the FDA to the Life Sciences industries to effectively investigate and locate cause and correct it. The CAPA workshop teaches proper identification and documentation of non-compliances (problems) and the proper corrective action.
  
  
• Solving Quality, Reg. and Tech. Issues During Dev. of Prefilled Syringes, Autoinjectors and Injectio
  May 5 - 6
  This course will provide a review and interpretation and discussion of relevant laws regulations, guidance and best practices for the design, development, manufacture, testing, registration and marketing of prefilled drug delivery including syringes, autoinjectors and pens. This is an expanded version of the current one day TRI training. The new training includes expanded technical information concerning stability programs, syringability force testing, design controls, compatability testing and includes additional case studies focusing on these topics.
  
  
• Principles of Effective Quality Auditing
  May 6
  This is an introductory course for new auditors who are or will be involved in performing quality assurance audits of quality systems. This course will enhance the ability those attending to deliver successful audits by relying on their professional experience and technical skills as well as by careful preparation, attendees. The auditors will learn the auditing cycle with a step – by – step guide to “putting the pieces of the puzzle together” using different technical tools. This is a dynamic course with classroom and discussions and exercises in small groups.
  
  
• CIP System Design and Engineering Integration: Options and Impacts
  May 6
  The course lecture, based on industry benchmarking and case studies, will present system engineering and automation aspects of Process/CIP integration. The focus of the course will be “real world” engineering options and their overall impact on facility delivery, including project cost, schedule, environmental, and personnel safety. The objective is for personnel involved in CIP project planning to gain an understanding of how early project decisions can impact their ability to deliver a validated facility on schedule and within budgetary constraints.
  
  
• Contact
  Stephanie Ko
  PDA Training and Research Institute
  Manager, Lecture Education
  Tel: +1 (301) 656-5900 ext. 151
  Email: ko@pda.org
  
  
  
• Location/Lodging Information
  Hotel Lumiere
  999 North Second Street
  Saint Louis, MO 63102
  Tel: +1 (314) 881-7803
  Reservations: +1 (877) 450-7711
  
  Rate
  Single/Double Occupancy: $119/night plus applicable taxes and fees. A block of rooms has been reserved at this hotel. Please mention PDA and reserve a room no later than April 19, 2009 by 5:00 p.m. local time in order to obtain the group rate of $119 dollars for single or double occupancy.