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Requirements for Establishing an Effective Cleaning Validation Program 2017

Start Date:
Thursday, 9 March, 2017
End Date:
Friday, 10 March, 2017 6:00pm
Speciality:
Pain Management, Rheumatology, Internal Medicine, Emergency Medicine, Pulmonary Medicine, Physical Medicine, Headache / Migraine, Health & Nutrition
Website:
http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900824SEMINAR?channel=mailer&camp=Seminar&AdGroup=meetings4docs_March_2017_SEO

Course "Requirements for Establishing an Effective Cleaning Validation Program" 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 should you 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 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 agenciesWho 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 auditorsAgenda: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 PlanDay 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 Speaker: Joy McElroyPrinciple Consultant at Maynard Consulting CompanyUpon earning a degree in Zoology at North Carolina State University, Joy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn 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: March 9th & 10th, 2017 and Time: 9:00 AM to 6:00 PM Venue: Four Points By Sheraton San Diego DowntownAddress: 1617 1st Avenue - San Diego, California, 92101 - United StatesPrice: Register now and save $200. (Early Bird) Price: $1,295.00 (Seminar for One Delegate) Until January 31, Early Bird Price: $1,295.00 from February 01 to March 07, Regular Price: $1,495.00Register for 5 attendees Price: $3,885.00 $6,475.00 You Save: $2,590.00 (40%)*Quick Contact:NetZealous DBA as GlobalCompliancePanel Phone: 1-800-447-9407Fax: 302-288-6884Email: support@globalcompliancepanel.com Normal 0 false false false EN-US X-NONE X-NONE /* Style Definitions */ table.MsoNormalTable{mso-style-name:"Table Normal";mso-tstyle-rowband-size:0;mso-tstyle-colband-size:0;mso-style-noshow:yes;mso-style-priority:99;mso-style-parent:"";mso-padding-alt:0in 5.4pt 0in 5.4pt;mso-para-margin-top:0in;mso-para-margin-right:0in;mso-para-margin-bottom:10.0pt;mso-para-margin-left:0in;line-height:115%;mso-pagination:widow-orphan;font-size:11.0pt;font-family:"Calibri","sans-serif";mso-ascii-font-family:Calibri;mso-ascii-theme-font:minor-latin;mso-hansi-font-family:Calibri;mso-hansi-theme-font:minor-latin;}

Location

Four Points By Sheraton San Diego Downtown 1617 1st Avenue - San Diego,
California,
92101 - United States

Organizer Details

Conference organized by NetZealous DBA as GlobalCompliancePanel

Address:
NetZealous LLC-globalcompliancepanel, 161 Mission Falls Lane, Suite 216, Fremont,CA94539, USA
Phone:
Event Manager
Email:
john.robinson@globalcompliancepanel.com

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