cGMSeminar schedule 2011

1. SEMINAR SCHEDULE FOR 2011.

2. COURSE # 00001 : HOW TO
PERFORM PROCESS VALIDATION
Course objective
Attendees will:
will
• Learn the elements of a validation life cycle
• 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
http://www.cgmpuniversity.com

3. WHO WILL BENEFIT
• Quality Managers and Quality • Space is limited register at :
Engineers in Medical device, www.cgmpuniversity.com
Pharmaceutical, Biotech and
dietary supplement industries.
• Regulatory personnel
• Manufacturing Engineers
• Process Engineers
http://www.cgmpuniversity.com

4. DATE AND LOCATION
WHEN? WHERE?
Sheraton hotel, San Francisco
February 22nd-23rd,2011
Int. Airport, CA
Orange county Hilton, Orange
May 17th-18th,2011
county Airport,CA
http://www.cgmpuniversity.com

5. COST AND
REGISTRATION
• The cost for this two day • Space is limited register at :
class is $ 1125 person www.cgmpuniversity.com
• Participants get free course
material and two text books:
Principles of process
validation, and How to
perform process validation.
http://www.cgmpuniversity.com

6. COURSE # 00002 : PRINCIPLES OF
CORRECTIVE ACTION/PREVENTIVE
ACTION/CAPA
Course objective
Attendees will:
will
• Learn the elements of a CAPA life cycle
• 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
http://www.cgmpuniversity.com

7. WHO WILL BENEFIT
The class is designed for:
• Quality Engineers Target Industries:
• Quality managers • Pharmaceutical manufacturing
• Regulatory personnel • Medical device
• Manufacturing Engineers • Biotech
• Process Engineers • Cellular therapy(stem cells)
• Manufacturing personnel • Blood banking
• Tissue banking
• Dietary supplements
http://www.cgmpuniversity.com

8. DATE AND LOCATION
WHEN? WHERE?
January 25th-26th 2011 Sheraton hotel, SFO int Airport,CA
Orange county Hilton/Orange county
June 14th-15th,2011
Airport,CA
http://www.cgmpuniversity.com

9. COST AND
REGISTRATION
• The cost for this two day • Space is limited register at :
class is $ 1225 person www.cgmpuniversity.com
• Participants get free course
material and two text books:
Principles of corrective Action
and Preventive Action, and
How to design a corrective
Action/Preventive Action
system
http://www.cgmpuniversity.com

10. COURSE # 00003 : HOW TO PERFORM
ROOT-CAUSE ANALYSIS
Course objective
Attendees will:
will
• Learn the THREE categories of Quality system problems
• 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 http://www.cgmpuniversity.com

11. WHO WILL BENEFIT
The class is designed for:
• Quality Engineers Target Industries:
• CAPA personnel • Pharmaceutical manufacturing
• Manufacturing Engineers • Medical device
• Process Engineers • Biotech
• Manufacturing personnel • Cellular therapy (stem cells)
• Quality Managers • Blood banking
• Tissue banking
• Dietary supplements
http://www.cgmpuniversity.com

12. DATE AND LOCATION
WHEN? WHERE?
Double Tree Hotel,San Jose Int.
March 15th-March 16th 2011
Airport, CA
May 31st -June 1st 2011 Sheraton Hotel, SFO int. Airport,CA
http://www.cgmpuniversity.com

13. COST AND REGISTRATION
• The cost for this two day • Space is limited register at :
class is $ 1225 person www.cgmpuniversity.com
• Participants get free course
material and two text books:
Principles of corrective Action
and Preventive Action, and
How to design a corrective
Action/Preventive Action
system
http://www.cgmpuniversity.com

14. COURSE #0004:CHANGE CONTROL
Course objective
Attendees will:
• 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

15. WHO WILL BENEFIT
The class is designed for: • Target Industries:
• Quality Engineers • Pharmaceutical
• Product design Engineers manufacturing
• Manufacturing Engineers • Medical device
• Process Engineers • Biotech
• Supplier Quality Engineer • Cellular therapy (stem cells)
• Quality Managers • Blood banking
• Tissue banking
• Dietary supplements

16. DATE AND LOCATION
WHEN? WHERE?
Sheraton Hotel, SFO Int. Airport,
June 14th-June 15th 2011
CA
Double Tree Hotel, San Jose Int.
April 12th-13th 2011
Airport, CA.
http://www.cgmpuniversity.com

17. COST AND REGISTRATION
• The cost for this two day • Space is limited register at
• http://www.cgmpuniversity.com
class is $ 1225 person
• Participants get free course
material and two text books:
Principles of corrective Action
and Preventive Action, and
How to design a corrective
Action/Preventive Action
system
http://www.cgmpuniversity.com