Seminar schedule 2011

SEMINAR SCHEDULE FOR 2011.SEMINAR SCHEDULE FOR 2011.

COURSE # 00001 : HOW TO PERFORM PROCESS VALIDATION

Course objectiveCourse objectiveAttendees willAttendees will:

• Learn the elements of a validation life cycle• Learn the elements of a Master Validation Plan ,and a

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• Learn the elements of a Master Validation Plan ,and a Validation Master Plan.

• Learn how to write an IQ protocol• Learn how to write an OQ protocol• Learn how to write a PQ protocol• Learn how to write a validation report• Learn the relationship between change control and

process validation

WHO WILL BENEFIT

• Quality Managers and Quality Engineers in Medical device, Pharmaceutical, Biotech and dietary supplement industries.

• Space is limited register at :www.cgmpuniversity.com


dietary supplement industries.• Regulatory personnel• Manufacturing Engineers• Process Engineers

DATE AND LOCATION

WHEN? WHERE?

February 22nd-23rd,2011 Sheraton hotel, San Francisco Int. Airport, CA


May 17th-18th,2011 Orange county Hilton, Orange county Airport,CA

COST AND REGISTRATION

• The cost for this two day class is $ 1125 person

• Participants get free course

• Space is limited register at : www.cgmpuniversity.com


material and two text books: Principles of process validation, and How to perform process validation.

COURSE # 00002 : PRINCIPLES OF CORRECTIVE ACTION/PREVENTIVE ACTION/CAPA


• Learn the elements of a CAPA life cycle• Learn the elements of a Quality system.


• Learn the elements of a Quality system.• Learn the role CAPA plays in a Quality system• Learn how to perform root-cause analysis• Learn how to design an effective CAPA system• Learn how to complete a CAPA file• Participate in a root-cause analysis workshop using real

problems from regulated industries

WHO WILL BENEFIT

The class is designed for:The class is designed for:•• Quality EngineersQuality Engineers•• Quality managersQuality managers•• Regulatory personnelRegulatory personnel

Target Industries:•• Pharmaceutical manufacturingPharmaceutical manufacturing•• Medical deviceMedical device


•• Regulatory personnelRegulatory personnel•• Manufacturing EngineersManufacturing Engineers•• Process EngineersProcess Engineers•• Manufacturing personnelManufacturing personnel

•• Medical deviceMedical device•• BiotechBiotech•• Cellular therapy(stem cells)Cellular therapy(stem cells)•• Blood bankingBlood banking•• Tissue bankingTissue banking•• Dietary supplementsDietary supplements

DATE AND LOCATION

WHEN? WHERE?

January 25th-26th 2011 Sheraton hotel, SFO int Airport,CA


June 14th-15th,2011 Orange county Hilton/Orange county Airport,CA






material and two text books: Principles of corrective Action and Preventive Action, andHow to design a corrective Action/Preventive Action system

COURSE # 00003 : HOW TO PERFORM ROOT-CAUSE ANALYSIS


• Learn the THREE categories of Quality system problems• Learn properties of System problems and tools to solve


• Learn properties of System problems and tools to solve them.

• Learn of process problems and the correct tools to solve them

• Learn properties of product related problems and how to distinguish them from systemic problems

• Learn the different tools used in root-cause analysis• Participate in actual root-cause analysis using the tools they

have learned

WHO WILL BENEFIT

The class is designed for:The class is designed for:•• Quality EngineersQuality Engineers•• CAPA personnelCAPA personnel•• Manufacturing EngineersManufacturing Engineers

Target Industries:Target Industries:•• Pharmaceutical manufacturingPharmaceutical manufacturing•• Medical deviceMedical device


•• Manufacturing EngineersManufacturing Engineers•• Process EngineersProcess Engineers•• Manufacturing personnelManufacturing personnel•• Quality ManagersQuality Managers

•• Medical deviceMedical device•• BiotechBiotech•• Cellular therapy (stem cells)Cellular therapy (stem cells)•• Blood bankingBlood banking•• Tissue bankingTissue banking•• Dietary supplementsDietary supplements

DATE AND LOCATION

WHEN? WHERE?

March 15th-March 16th 2011 Double Tree Hotel,San Jose Int. Airport, CA


May 31st -June 1st 2011 Sheraton Hotel, SFO int. Airport,CA

COURSE #0004:CHANGE CONTROL

Course objectiveCourse objectiveAttendees will:• Learn the role of change control in product design• Learn the role of change control in product design• Learn the role of change control in manufacturing• Learn the importance of supplier change control• Learn risk assessment tools for fit form and function• Learn Impact assessment tools for a proposed change

WHO WILL BENEFITWHO WILL BENEFIT

The class is designed for:The class is designed for:•• Quality EngineersQuality Engineers•• Product design EngineersProduct design Engineers

•• Target Industries:Target Industries:•• Pharmaceutical Pharmaceutical

manufacturingmanufacturing•• Product design EngineersProduct design Engineers•• Manufacturing EngineersManufacturing Engineers•• Process EngineersProcess Engineers•• Supplier Quality EngineerSupplier Quality Engineer•• Quality ManagersQuality Managers

•• Medical deviceMedical device•• BiotechBiotech•• Cellular therapy (stem cells)Cellular therapy (stem cells)•• Blood bankingBlood banking•• Tissue bankingTissue banking•• Dietary supplementsDietary supplements

WHEN? WHERE?

June 14th-June 15th 2011 Sheraton Hotel, SFO Int. Airport, CA

DATE AND LOCATIONDATE AND LOCATION


April 12th-13th 2011 Double Tree Hotel, San Jose Int. Airport, CA.

COST AND REGISTRATIONCOST AND REGISTRATION



• Space is limited register at• http://www.cgmpuniversity.com



Seminar schedule 2011

Education

Transcript of Seminar schedule 2011