Call-in teleconferencing
Video demonstrations included in the presentation
Facility Start-Up
April 19,2016 WEBINAR                                                       
NOON - 1:30 pm EDT

A well planned and documented start up and validation strategy is key in the successful start up of a facility. A smooth transition from construction to production is desired. Start up, commissioning and qualification activities can become confusing.   Qualification of a cleanroom is a critically important task for any healthcare company manufacturing in controlled environments.  There is often a push from management to get the new cleanroom(s) or renovated cleanroom(s) into a state that is ready for production use as soon as possible.   The proper balance of compliance and business risk often comes into play.  The people responsible for planning the qualification of a cleanroom need to determine how much qualification is required to ensure that the cleanroom(s) are ready for use and will perform as expected.  Often times, people confuse commissioning activities, cleanroom classification requirements, cleanroom qualification (EMPQ) activities and routine monitoring.  This course will describe the differences between each of these separate activities and look at ways of applying risk to rationalize the appropriate number of runs, sample site locations, number of samples to collect, etc. How many runs is enough for EMPQ?  How much data is needed prior to going into production?  How do you ensure you have rationalized your plan using risk? This course will describe risk based approaches as well as why requirements are in place for these activities. 

In this course we will discuss:

  • Cleanroom Qualification Regulations and Guidance

  • Commissioning of Cleanrooms

  • Cleanroom Classification

  • Cleanroom Qualification (EMPQ)

  • Baseline Monitoring

  • Routine Monitoring

  • Risk Analysis Tools for Cleanroom Qualification  Activities

  • Clarifying the Differences between these Activities

  • Business versus Compliance Balance

  • Documentation of Risk Rationales

$385 for one person
$700 2-5 people
$999 6-10 people
Instructor:    Marsha Stabler Hardiman  

Marsha Stabler Hardiman has over 20 years of experience as a Microbiologist working in the Pharmaceutical, Biotechnology and Medical Device fields.  Marsha has a Bachelors in Biology from Western New England University in Springfield, MA.  Marsha is an expert in industrial Microbiology test methods from environmental monitoring (EM) and utility system microbial testing to intermediate product testing through final product sterility testing.  Marsha also served as a Microbiology Expert - Notified Body regulatory inspector for CE certification of medical devices and has extensive knowledge in quality systems.  Over her career, Marsha has established numerous EM programs for many different medical device and pharmaceutical companies. 

Marsha is active in industry and currently serves on the Parenteral Drug Association (PDA) Science Advisory Board; is leading a PDA Task Force on Microbial Data Deviations; serves on the PDA Microbiology Meeting Planning Committee and has been the chair of the PDA Annual Meeting.  

Marsha is a Senior Consultant for Concordia ValSource and in this role helps companies implement quality risk management into their quality management systems and validation programs.  Marsha currently helps companies reassess their existing EM programs and re-select sample locations based on risk.