The Life Cycle Approach to Cleaning Validation (com) A

Venue:

The Life Cycle Approach to Cleaning Validation (com) A

Tampa,  

Time:

From  2018-12-06 13:30:00  to  2018-12-07 21:00:00
Event Description
The Life Cycle Approach to Cleaning Validation *** LIMITED TIME OFFER: FREE $100 AMAZON GIFT CARD! ***REGISTER TODAY! 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 Seminar Fee Includes:LunchAM-PM Tea/CoffeeSeminar MaterialUSB with seminar presentationHard copy of presentationAttendance Certificate$100 Gift Cert for next seminar  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 Topic Background: Cleaning validation programs for pharmaceutical firms are a regulatory expectation. The FDA, Health Canada, WHO and other regulatory agencies have published their expectations for a good cleaning validation program. There are also numerous textbooks, articles, and other helpful resources such as PDA’s Technical Report #29 (Revised 2012) “Points to Consider for Cleaning Validation”. The risk-based regulatory initiatives of the FDA focus new attention on the risks of cross-contamination. Some firms have highly potent molecules in their product mix. Advanced analytical methods are emerging with promises to detect molecules to the ppb levels. Understanding and implementing new technologies and principles pause challenges to a cleaning validation specialist to establish, manage and maintain a scientifically sound cleaning validation program. 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. AGENDA Day 01(8:30 AM - 4:00 PM) Registration Process: 8:30 AM – 9:00 AM 09:00 AM: STERIS introduction 09.30 am – 10.00 am: An introduction to Cleaning Validation of the 21st Century Cleaning Validation Background The Process Life Cycle Approach 10.00 am – 10.45 am: Stage 1: Process Design The commercial cleaning process is defined during this stage based on knowledge gained through development and scale-up activities Aspects to consider in the selection of cleaning agent and method Defining critical parameters through experimental studies Process equipment design review 10.45 am – 11.00 am: Break 11.00 am – 12.00 pm: Scientific approach to establishing residue limits and acceptance criteria 12.00 pm – 01.00 pm:Lunch 01.00 pm – 01.30 pm: Activity #1 Limit Calculations 01.30 pm – 02.30 pm: Grouping strategies for products and equipment Documentation of process design stage Other miscellaneous issues to consider during this stage 02.30 pm – 3.00 pm: Activity #2 Sampling sites 03.00 pm – 3.15 pm: Break 3.15 pm - 3.30 pm: Stage 2: Process Qualification The process qualification stage should evaluate the process design to determine if it can reproduce the expected results 3.30 pm – 4.00 pm: Analytical method validation Day 02(8:30 AM - 4:00 PM) 9.00 am – 9.30 am: Microbial methods and sampling (slides 119 – 124) 9.30 am – 10.15 am: Activity #3 Swabbing 10.15 am – 10.30 am: Break 10.30 am – 11.30 am: Cleaning documentation readiness (master plan, protocols, and SOP) Equipment qualification and utilities readiness Personnel training program and tools Validation execution Interim documentation and final package 11.30 am – 12.00 pm: Activity #4 Cleaning SOP best practices 12.00 pm – 1.00 pm: Break for lunch 1.00 pm – 2.00 pm: Stage 3: Continued Process Verification The main purpose of the third validation stage is continuous assurance that the cleaning procedure is performing as expected and remains in a state of control for the life of the product(s) being manufactured Monitoring and data trending Process analytical technology Preventive maintenance 2.00 pm – 2.45 pm: Periodic review and retraining Change control procedures, deviations, OOS, and CAPA Revalidation vs. continued process verification 2.45 pm – 3.00 pm: Break 3.00 pm – 4.00 pm: Review Annex 15 & Wrap up 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”. Beth Kroeger,Technical Services Manager, STERIS Corporation Beth Kroeger is a Technical Services Manager for the Life Sciences Division of STERIS Corporation. She currently provides global technical support related to process research cleaners, cleaning validation and critical environments and frequently speaks on these topics for the Institute of Validation Technology (IVT), United States Pharmacopeia (USP), International Society for Pharmaceutical Engineering (ISPE), Parenteral Drug Association (PDA) and the National Institute for Bioprocessing Research and Training. Beth has over 20 year’s industry experience in Biopharmaceutical and Oral Solid Dose manufacturing operations. Prior to her current position, Beth was employed by Janssen Biotech where her areas of expertise included large scale fermentation systems, both continuous perfusion and fed batch, and downstream operations including large scale purification processing, viral removal, UF and final fill. Beth has held positions as an Operations Manager, Senior Compliance Associate and as the manufacturing lead on a cross-functional team responsible for the scale-up and technical transfer of 4 biopharmaceuticals. In her role in manufacturing and compliance, she conducted hundreds of investigations relating to excursions, malfunctions, failures and errors. She earned a B.S. in Biological Sciences from the University of Missouri, St. Louis and most recently completed a Fermentation Technology program at Massachusetts Institute of Technology. Please contact the event manager Marilyn (marilyn.b.turner@nyeventslist.com ) below for:- Multiple participant discounts- Price quotations or visa invitation letters- Payment by alternate channels (PayPal, check, Western Union, wire transfers etc)- Event sponsorshipsNO REFUNDS ALLOWED ON REGISTRATIONSService fees included in this listing.-----------------------------------------------------------------METRICSTREAM INC - New York Events Listhttp://www.NyEventsList.comhttp://www.BostonEventsList.comhttp://www.SFBayEventsList.com-----------------------------------------------------------------MYL181023CEV VIO181027UPD