Regulatory Requirements and Principles for Cleaning Validation

Venue:

Regulatory Requirements and Principles for Cleaning Validation

Tampa,  

Time:

From  2018-12-06 13:30:00  to  2018-12-07 21:30:00
Event Description
Course Description: This 2 day course will cover practical guidance on cleaning validation regulatory compliance, in conjunction with, risk-based, reasonable and informed decision making and activity planning. This two day interactive course will cover fundamental principles of a cleaning validation program, exploring such concepts as the determination of residues to be targeted, selection of analytical and sampling methods, determination of appropriate limits in various pharmaceutical and biotechnology processes, and establishment of scientific rationales acceptable to regulatory inspectors. The program will describe the requirements for establishing an effective cleaning validation program, including the development of a general policy, a "Cleaning Validation Master Plan" and the appropriate documentation for each study to be performed. In addition, requirements for maintenance of the validated status will be reviewed. Regulatory requirements and the latest industry practices will also be included in the discussion. Learning Objectives: By the end of this course attendees will: Understand the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the product Understand the FDA perspectives on cleaning validation and areas of concern during regulatory inspections Be able to set up cleaning validation procedures, protocols and reports that meet current FDA, WHO, PIC/S and EU regulations Prepare and defend your own cleaning validation approach/program and avoid costly delays and/or rejections by regulatory agencies Who will Benefit: Attendance at 2 day seminar will be beneficial to personnel directly involved in the development of cleaning procedures, cleaning validation programs and plans. Additionally, those responsible for cleaning validation protocols and execution activities, including validation and laboratory personnel, as well as, beginning or seasoned operational personnel who will eventually participate in such efforts, will find this course particularly useful. This includes Analytical Method Development, Quality Control and Quality Assurance personnel. Individuals in management who interact with the above or communicate with regulatory agency inspectors to rationalize or defend cleaning validation programs will also benefit from attending this course. There are no prerequisites for attending, but a basic knowledge of general science and equipment cleaning processes is helpful. Senior quality managers Quality professionals Production supervisors Validation engineers Process owners Quality engineers Quality auditors Speaker: Koshy GeorgeSr. Cleaning Validation Consultant, Quantic Group, LLC. Validation and QA Specialist with over 25 years of experience in the pharmaceutical and biopharmaceutical industries. Cleaning Validation SME with hands on experience in developing validation strategies, QA review and approval, evaluate quality management systems, perform audits, quality investigations of GMP activities, recommend CAPA, trouble shooting and cycle development, authoring master plans, protocols and reports, developing procedures to complete validation related gaps, consent decree remediation, GxP and regulatory body requirements, as well as project management. He has conducted training sessions for cleaning validation specialists. He has helped to find root cause to several persistent cleaning validation failures. He has worked with cleaning validation teams under Consent Decree in Wyeth, Schering-Plough, J & J-McNeill, and Sanofi-Genzyme. He has been an instructor of Cleaning Validation with IVT, IPA and PDA. He has served in the team that developed the PDA Technical Report #29 (Revised in 2012) “Points to Consider for Cleaning Validation”. For Registration - https://www.complianceonline.com/regulatory-requirements-and-principles-for-cleaning-validation-seminar-training-80353SEM-prdsm?channel=eventbrite          Note: Use coupon code REFERRAL10 > and get 10% off on registration.