Regulatory Requirements and Principles for Cleaning Validation 2017
- Start Date:
- Thursday, 14 September, 2017
- End Date:
- Friday, 15 September, 2017 6:00pm
- Oncology, Nephrology, Neurology, Psychiatry, Hepatology, Cardiology, Endocrinology, Infectious Disease
Course "Regulatory Requirements and Principles for Cleaning Validation" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: 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. Why you should attend: 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.
Areas Covered in the Session: Understand the importance and underlying principles of cleaning validation and the requirements to have adequate cleaning procedures for manufacturing equipment in contact with the productUnderstand the FDA perspectives on cleaning validation and areas of concern during regulatory inspectionsBe able to set up cleaning validation procedures, protocols and reports that meet current FDA, WHO, PIC/S and EU regulationsPrepare 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 ManagersQuality ProfessionalsProduction SupervisorsValidation EngineersProcess OwnersQuality EngineersQuality Auditors Agenda: Day 1 Schedule Lecture 1:FDA Requirements and Industry Standard PracticesLecture 2:How to Develop/Review your Cleaning Procedures and the Adequate Selection of Cleaning Agents and ParametersLecture 3:How to Develop a Cleaning Validation Policy/ProgramLecture 4:How to Implement a Robust Cleaning Validation Plan Day 2 Schedule Lecture 1:Laboratory Issues in CleaningLecture 2:Microbiological aspects of a cleaning validation program for manufacturing equipmentLecture 3:Keys to Cleaning Validation Maintenance - Remaining CompliantLecture 4:Current FDA concerns about validation of cleaning processes SpeakerJoy McElroyPrinciple Consultant, Maynard Consulting Company Upon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & Up John performing Environmental Monitoring and Sterility Testing.
Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their Quality Control Lab.Now with 12 years experience as a consultant, and over 20 years total experience in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous Companies such as Mallinckrodt, Wyeth Lederle, Merck, BioMerieux, Catalent, Phillips Medisize, Xcelience, and Novartis.Joy specializes in Equipment Qualification, Cleaning Validation,Sterilization, Environmental Monitoring, and GMP Compliance Auditing Location: San Diego, CA Date: September 14th & 15th, 2017 and Time: 9:00 AM to 6:00 PMVenue: WILL BE ANNOUNCED SOON, San Diego, CAPrice: Register now and save $200. (Early Bird)Price: $1,295.00 (Seminar Fee for One Delegate)Until August 10, Early Bird Price: $1,295.00 From August 11 to September 12, Regular Price: $1,495.00Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)* Sponsorship Program benefits for "Quality Assurance Auditing for FDA Regulated Industry" seminar At this seminar, world-renowned FDA Regulated Industry subject matter experts interact with CXO's of various designations.
Executives who carry vast experience about FDA Regulated Industry and Experts get down to discussing industry-related best practices, regulatory updates, changes in technologies, and much more relating to FDA Regulated Industry. As a sponsor of these seminars, you get the opportunity to have your product and company reach out to C-Level executives in FDA Regulatory-related industries and become known among these elite executives and subject matter experts. Apart from being seen prominently at these globally held seminars, you also get talked about frequently in our correspondences with our experts and these participants. For More Information- https://www.globalcompliancepanel.com/control/sponsorship
DoubleTree by Hilton San Diego Downtown 1646 Front St,
Conference organized by NetZealous DBA as GlobalCompliancePanel
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