This document outlines the schedule and details for four seminars on topics related to quality systems in regulated industries. The first seminar is on process validation and will teach attendees how to develop validation protocols and reports. The second is on corrective and preventive action and will cover quality systems and root cause analysis. The third focuses on root cause analysis tools. The fourth addresses change control. All seminars will be held in February, May, June and April at hotels in San Francisco and Orange County, California. The cost is $1,125-1,225 per person.

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