ispe
ISPE Delaware Valley Chapter cordially invites you to our monthly program
FDA Failure Investigations
and Quality Systems
DVC Monthly
Program:
 
Date: 
 
November 17, 2009
 
Time:  5:00pm
 
Directions:
 
Click Here For Directions
Upcoming DVC Monthly
Events:  
 
Education Series
November 10
 
Holiday Party
December 8
 
Education Series
December 10
 
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Dear Member: 
 
We are excited to have Anita Michaels from the Food & Drug Administration speak to our membership on November 17th.  Ms. Michaels will provide us with a presentation on the FDA Failure Investigations and Quality systems.  Some of the important subjects addressed in this presentation include key items inspected in investigations, CFR 211 requirements for APR, CGMP concepts for laboratory and manufacturing investigations, CAPA Change Control related to investigations, and CFR 211 FDA 483 citations related to investigations. Additional relevant topics will also be covered.
 
Please join us on November 17th at the Desmond Hotel for this special program event.

Michael J. Brennan
Program Manager
Program Details
 
WHEN:
Tuesday, November 17, 2009
 
WHERE:
Desmond Hotel & Conference Center
1 Liberty Blvd
Malvern, PA 19355
(610) 296-9800

TIME:
Registration: 5:00 - 6:00pm
Dinner: 6:00 - 7:00pm
Presentation starts: 7:00pm
 
COST:
Members - $60  
Non-Members - $85
Students - Free  
 
REGISTRATION:
 
If you believe there will be a large attendance from your company, please contact Ron Dunn (610-351-3874) to discuss the details of a group rate.
Program Topic Summary
 
1.     What is Quality
2.     What is Quality By Design
3.     CGMP 21. CFR 211 regulations the legal requirements for conducting and documenting Investigations.
4.      FDA inspections; Quality Systems and Production Systems. Key items inspected related to investigations.
5.     Why it is important to conduct thorough Investigations.
6.     The CGMP 21. CFR 211 requirements for APR. How trending, analysis and review of Investigations can drive long term corrective actions.
7.     Key CGMP concepts for conducting and documenting thorough accurate Laboratory Investigations and deviations.
8.     Key CGMP concepts for conducting and documenting thorough accurate Manufacturing Investigations and deviations.
9.     CAPA a well known CGMP regulatory concept.
10.CGMP concept of Change Control related to Investigations
11.The importance of a robust quality system and management oversight.
12.Examples of CGMP 21. CFR 211 FDA 483 citations related to Investigations.
13.Q&A session
Speaker Bios

 

Anita R. Michael 
 
Anita R. Michael started her professional career with the Food and Drug administration in 2002. She is a FDA Certified Pharmaceutical Investigator for the Philadelphia District Office in Pennsylvania specializing in pharmaceuticals. In this position she is responsible for conducting highly technical pharmaceutical inspections and high priority investigations related to pharmaceuticals. She conducts quality systems based GMP and pre-approval inspections. She evaluates the firm's quality systems and GMP Quality assurance program for commercial operations. She is a member of the International Inspectional Cadre and represents the FDA overseas conducting highly complex pharmaceutical inspections. In addition to conducting pharmaceutical inspections she also conducts Bioresearch Monitoring (BIMO) inspections for Clinical Investigators involved in Phase III Human Clinical Trials. She was recently certified in Upstream and Downstream Bio-processing from BTEC North Carolina State University and has completed her certification in Process Analytical Technology (PAT) at Duquesne University. Prior to joining the FDA she worked as a Regulatory Submissions Specialist in Regulatory Affairs for a global pharmaceutical company. She attended the Medical College of Pennsylvania School of Medicine as a medical student and was in the process of becoming a Medical Doctor when she decided instead to pursue a career focused in Regulatory and Pharmaceutical Development. She received her undergraduate degree from Temple University's School of Science and Technology focused in Chemistry, Biology and Sociology while conducting research at the University level. She was accepted into the Future Physicians of America program at Temple School of Medicine. She graduated magna cum laudewith high honors and distinction in science.
Program Sponsors
 
 
Genesis Engineers Inc 
 
bahama breeze
 
bahama breeze
 
bahama breeze
            
____________________________________________________
 

International Society for Pharmaceutical Engineering

International - www.ispe.org

 
 

Delaware Valley Chapter -www.ispe.org/delawarevalley

 
 
ISPE - Delaware Valley Chapter
1797 Chapel Avenue
Allentown, PA 18103

Phone - 610/351-3874

Fax - 610/351-9136    
www.ispe.org/delawarevalley
 
Chapter Manager: Ron Dunn
 
 
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