BEGIN:VCALENDAR PRODID:NingEventWidget-v1 VERSION:2.0 METHOD:PUBLISH BEGIN:VTIMEZONE TZID:America/New_York X-LIC-LOCATION:America/New_York BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:19700308T020000 RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:19701101T020000 RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU END:STANDARD END:VTIMEZONE BEGIN:VEVENT UID:2140535:Event:67346 DTSTAMP:20260522T180134Z SUMMARY:Seminar on Modern Approaches to Process Validation: Requiremen ts for Process Design, Design of Facilities and the Qualification of E quipment and Utilities at Copenhagen, Denmark DESCRIPTION:Overview:Companies face many common issues and confusion w hen creating or revamping their validation programs. Some of these com mon issues are:• Company has expertise in its process validation pro gram but can never quite get is arms around the facility and equipment changes that require never ending equipment qualification (IQ, OQ, PQ ),• Customer or 483 audit findings require the company to deviate fr om its own validation program to meet the needs of the FDA or the cust omer • For systems that employ software and hardware, how does the c ompany manage the validation activities (i.e. through the software val idation effort or through the equipment qualification program? Well, t he answers to these and many, many more typical questions are now avai lable in this simple to understand, yet detailed training session desi gned to help manufacturers of FDA regulated products build (or rebuild ) a sustainable validation program. Why should you attend?Attend this FDA validation seminar to get deep knowledge about: • How to define a Sustainable Structure of a Firm's Validation Program• Understand H ow Change Control and Other Quality Programs Feed Into the Validation Program• Offer Usable Protocol and Other Validation Program Document Templates• Define Minimal Recommended Tests and Verifications for o Equipment Qualificationo Process Validationo Software Validation• C ommon Pitfalls to Avoid When Executing Validation Protocols• How to Estimate Costs and Time Associated with Validation• How to Respond t o Customer and Regulatory Audit Observations Associated with Validatio nAreas Covered in the Session:• Basics Of Validation• The Componen ts of a Sustainable Validation Program • Other Programs that Feed th e Validation Program (1 Hour)• Equipment, Utility, and Facility Qual ification• Process Validation• Software Validation• Time and Cos ts of Validation• Responding to Validation and Other Related Audit F indingsWho Will Benefit:• Internal Auditors• Regulators• Legal D epartments• Compliance Officers• Validation Managers• QC Manager s• QA Managers• Facilities and Engineering Department StaffAgenda: Day 1 Schedule:Lecture 1: Understanding the Basics of Validation• Re gulatory References• Validation TerminologyLecture 2: The Components of a Sustainable Validation Program• Design Qualification• FATs a nd SATs• Commissioning• The Validation Master Plan• The Validati on Project Plan• Standard Operating Procedures (SOPs)• Protocols†¢ Reports• Additional Software Validation DocumentsLecture 3: Other Programs that Feed the Validation Program• Change Control• Complai nt Handling• CAPAs• Deviation Management• Maintenance• Sales\n \nVenue: Hilton Copenhagen AirportVenue Address: Ellehammersvej 20, Co penhagen, 2770Date: December 10th & 11th, 2015, Time: 9:00 AM to 6:00 PMPrice: $1,695.00 (Seminar for One Delegate - Without Stay) &Price: $ 2,095.00 (Seminar for One Delegate - With Stay)\nRegister now and save $200. (Early Bird) Until November 22, Early Bird Price: $1,695.00 fro m November 23 to December 08, Regular Price: $1,895.00 Until November 22, Early Bird Price: $2,095.00 from November 23 to December 08, Regul ar Price: $2,295.00 Quick Contact:NetZealous DBA as GlobalCompliancePa nel 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA Phone: 1 -800-447-9407Fax: 302-288-6884Email: support@globalcompliancepanel.com Website: http://www.globalcompliancepanel.comRegistration Link - http ://bit.ly/1QrgUT2\n\nFor more information visit https://medtechiq.ning .com/events/seminar-on-modern-approaches-to-process-validation-require ments DTSTART;TZID=America/New_York:20151210T090000 DTEND;TZID=America/New_York:20151211T180000 CATEGORIES:seminar LOCATION:Copenhagen, Denmark WEBSITE:http://bit.ly/1QrgUT2 URL:http://bit.ly/1QrgUT2 CONTACT:1-800-447-9407 ORGANIZER:NetZealous LLC, DBA GlobalCompliancePanel ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/ file/get/2562013364?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob inson":https://medtechiq.ning.com/profile/JohnRobinson END:VEVENT END:VCALENDAR