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 Cleaning Validation of APIs 
 
March 15, 2017 WEBINAR
NOON - 1:30 pm Eastern Standard Time 
 
.This Web Seminar will present a detailed overview of cleaning validation for Active Pharmaceutical Ingredients (APIs) from product contact surfaces of equipment in the pharmaceutical industry. All phases of cleaning validation: cleaning assessment, cleaning development, cleaning validation and cleaning monitoring will be discussed with the emphasis on the unique challenges and opportunities for an API cleaning validation program.
 
The cleaning assessment phase evaluates the types of residues associated with API manufacturing, their interrelationships the challenges they present for cleaning. The cleaning process is evaluated in relation to the next batch or product to be manufactured and the level of cleanliness required for the next batch or product is addressed. 
 
The cleaning development phase takes the cleaning assessment and develops a cleaning process based on the physical properties of the residues, a thorough evaluation of the equipment including geometry and material of construction, and the existing or proposed draft cleaning procedure. Cleaning process development optimizes the cleaning parameters to a level that assures successful validation. 
 
The cleaning validation phase will provide documented evidence through an executed protocol which provides a high degree of assurance that a cleaning procedure consistently removes residues to pre-determined acceptable levels and the cleaning procedure process capability parameters can be established to provide ongoing assurance that the cleaning procedure remains in a state of control. 
 
The cleaning monitoring phase will provide documented evidence that the validated cleaning program remains in a state of control. Annual document review including non-conformances, and change control evaluate whether the cleaning procedure under review continues to be effective and has not undergone changes that might impact the validated state of the procedure. Periodic testing, as described in an annual schedule, will demonstrate continued control of the cleaning procedures.
 
Change controls affecting the validated cleaning procedure will trigger the need for a cleaning assessment. Change control can be the result of additions of products or equipment to the cleaning strategy, changes to the existing manufacturing process, cleaning procedure or analytical test method, or non-conformances to the existing cleaning procedure.
 
Teaching objectives for this presentation include:
 
  • The approach to cleaning validation of APIs
  • Cleaning assessment of API residues
  • Cleaning development including residues, equipment and processes 
  • Cleaning acceptance criteria 
  • Rinse versus swab sampling options
  • Test method options
  • Cleaning validation execution
  • Establishing a cleaning monitoring program
  • Change control back to cleaning assessment
 
 
FEE: 
$385 for one (1) person.
$700 for 2-5 people
$999 for 6-10 people
 
Instructor: Richard Forsyth
 
Richard Forsyth is a Principal Consultant with Forsyth Pharmaceutical Consulting. He is responsible for customer support for Cleaning Validation and Cleaning related topics. He has worked as a consultant for four years and prior to that worked in as an Associate Director with Merck & Co. for 31 years. He has been involved with Cleaning Validation for over 20 years. Mr. Forsyth has a broad range of analytical experience including methods development and validation as well as formulation development and project management. Academic training includes an MS in Chemistry and an MBA in Management, both from St. Joseph’s University in Philadelphia, Pennsylvania, USA.
 
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