Establishing Limits for Cleaning Validation

Tuesday, July 01, 2014 10:29 AM

July 10, 2014 WEBINAR

NOON - 1:30 pm Eastern Daylight Time

Cleaning validation is a key part of pharmaceutical, biopharmaceutical, and medical device manufacturing.  One of the critical steps in performing a successful cleaning validation is establishing the limits of residue that can remain on the surface being cleaned.  Several factors can impact the selection and validation of these residual limits, such as sampling technique, analytical methodology, and areas of non-uniform contamination.

During the webinar, we will explore approaches to establishing limits for cleaning validation, specifically looking at the following areas:

  • Product grouping- We will look at a matrix approach to product grouping and investigate the most relevant product characteristics in order to develop a robust approach to product grouping.
  • Sampling methods- We will compare the two most often used sampling methods, swab sampling and rinse sampling, and elaborate on the appropriate usage of each sampling method
  • Detection methods- We will look at a sampling of the many detection methods available and offer insight on the methods’ respective advantages and disadvantages versus one another.
  • Calculating limits- By detailing the factors that are used in the limit calculation, we will give the user a robust approach to calculating residue limits for a variety of dosage forms and products.

FEE

$385 for one person

$700 2-5 people

$999 6-10 people  

Instructors: Paul Lopolito and Michael Gietl

Paul Lopolito is a technical services manager for the Life Sciences Division of STERIS Corporation (Mentor, Ohio). He currently provides global technical support related to critical environment and process research cleaners, which includes field support, site audits, training presentations and educational seminars. Paul has over 15 years of industry experience and has held positions as a technical services manager, manufacturing manager and laboratory manager. Paul is a frequent speaker at industry events including the PDA, ISPE, INTERPHEX, AALAS, and IVT. Paul has published several articles and book-chapters related to cleaning and cleaning validation. He earned a B.A. in Biological Sciences from Goucher College in Towson, MD.

Michael Gietl is a Technical Service Specialist for the Life Sciences Division of STERIS Corporation (Mentor, OH).  He currently provides global technical support related to Sterility Assurance Products and Process Cleaners including field support, site audits, and training presentations and educational seminars.  Michael has 9 years of industry experience in a cGMP regulated environment holding positions in Quality and Validation.

Michael has specific experience working in the quality unit of bulk active pharmaceutical ingredient (API) manufacturing with direct experience in the development and validation of analytical test methods and the validation of process cleaning methods.  Michael earned a B.S. in Chemistry from the University of Missouri in Columbia, MO and an M.B.A. from the University of Missouri in St. Louis, MO.  He also holds certifications as a Six Sigma Green Belt and Quality Manager.

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