GMPs and SOPs in the Microbiology Laboratory tend to evolve as a spin-off of the analytical chemistry laboratory.  Likewise the facility is often pushed into the little space that is left after the QC lab has been assigned two or three larger rooms.  As a result there is often inadequate space to allow separation of “dirty” activities such as strain handling and growth promotion testing, from “clean activities” such as bioburden testing or water sample testing.  Process flows are often awkward and refrigerators, incubators and other storage areas double up for storage of sterile media, test samples prior to testing and bacterial slants awaiting use in growth promotion test.  Small wonder that production claim samples were “contaminated in the laboratory” or results were false positives.  This course will discuss possible design layouts for a laboratory as well as the need for differential pressures, also considering available alternatives such as the use of dedicated biological safety cabinets.

Essential topics

• Microbial Control Strategy for Production: product and process and for Microbiology Laboratory
• Separation of activities: “dirty” from clean
• Microbiology Laboratory design for successful workflow
• Focus on aseptic practices
• Disinfection and Sanitization
• Cleanroom and general laboratory operation to minimize false positives
• Risks posed to production by incorrect personnel practices within and outside the laboratory
• Microbial isolates: identification, strain maintenance and libraries
• Growth promotion testing: how to maximize the value of these tests

Learning Keys

• Become familiar with regulations and guidance in this critical field
• Understand why the Microbiology learned in universities is different to applied Microbiology in the pharmaceutical industry
• Learn about media controls to maximize microbial recovery
• Become familiar with disinfectants and understand the difference between cleaning and sanitization
• Learn why disinfectants fail
• Understand the role of the microbiologist in the laboratory and in educating colleagues outside the laboratory
• Understand how to handle microbiological data deviations
• Learn to conduct effective failure investigations
 

If you are working in the Microbiology Laboratory or have a supervisory role or work in Quality Assurance to audit and oversee the Microbiology Laboratory you cannot afford to miss this course.  The course will also be of particular value to engineers and maintenance personnel involved in the design of HVAC systems and layouts for facilities that include Microbiology Laboratories.  Production and operations personnel will benefit from understanding how the laboratories design, operation and maintenance serves their needs.

Karen Ginsbury, B.Pharm, M.Sc, MRPharmS

Has over twenty years of experience in the pharmaceutical industry.  With a Bachelor of Pharmacy degree from the University of London (“The Square”) and a Master of Science in Microbiology from Birkbeck College, University of London, Karen started off with a well-rounded foundation in the basic skills appropriate to the pharmaceutical industry.  She has worked in industry for most of her career, initially in Research and Development at Smith and Nephew in England and then for seven years at Teva Pharmaceutical Industries, today the world’s largest generic manufacturer.  After leaving Teva, Karen set up her own consultancy company, PCI Pharmaceutical Consulting Israel Ltd which has been providing services to the pharmaceutical industry worldwide for the past 14 years. 

PCI regularly works with pharmaceutical, biotech and API manufacturers to assist them in resolving compliance issues with regulatory authorities, in setting up, maintaining and upgrading or improving their quality systems, performing audits at vendors, contract manufacturers, laboratories as well as helping clients successfully prepare for FDA, Health Canada, EU and local regulatory inspections.Karen was responsible for setting up the compliance department at Teva and published a book on compliance auditing, still available in the USA, that was purchased by most of the multi-national pharmaceutical companies as well as by the US FDA.

Karen regularly lectures around the world on quality topics and is renowned for her lively and engaging style of presentation.  She was winner of the Institute of Validation Technology’s “Presentation of the Year Award” in 2006 and their “Webseminar of the Year Award” in 2007.

Karen is an active volunteer in the Parenteral Drug Association (PDA) and was awarded the 2008 Gordon Personeus award honoring a PDA member for his or her long-term acts or contributions that are of noteworthy or special importance to PDA.  Karen is currently co-editing the PDA Technical Report on GMPs for Investigational Products.
 

8 & 9 November 2010

08.00am Registration&Continental Breakfast
08.30am Course begins
10:00am Mid-morning Refreshment Break
10:30am Course Continue
12:30pm Luncheon
13.30pm Course Continue
15:00pm Mid-Afternoon Refreshment Break
15:30pm Course Continue
17:00pm Question&Answers
17:30pm End of the day

Ramada Plaza Istanbul,
Halaskargazi Cad. No:139-151, 34373 Osmanbey-Sisli – Istanbul – Turkey
Info & Reservation: +90-212-44 0 272
Tel: +90 – 212 – 315 44 44
Fax: +90 – 212 – 315 44 45
Web: www.ramadaplazaistanbul.com

One person from 900.00 Euro/person (+%18VAT)

Two person from 810.00 Euro/person (+%18VAT)

Three person from 765.00 Euro/person (+%18VAT)

Registration Fee Includes;
Presentation Materials, Certificate of Attendance, Luncheon and Refreshments

Cancellations / Substitutions: Registration may be transferred to a member of the same organization at any time.  Please note that cancellations after October 08, 2010 will not be accepted. All cancelations are subject to a 100 Euro processing fee. Academia reserves the right to cancel an event. Academia is not responsible for any airfare, hotel, or other costs incurred by registrants. Speakers subject to change without notice.

Method of Payment: Please note that payment is required in advance of the conference. Please choice either with bank transfer or cheque that information given below. Confirmation of your registration will be sent. Registrations received without payment will not be processed.

Please make cheques payable to:

"Academia Yasam Bilimleri Merkezi Ltd.Sti"
Perpa Tic. Is Merkezi, B Blok, Kat:5, No:480 34384 Sisli, Istanbul, Turkiye

For Bank Transfers:
Bank Name: TURKIYE IS BANKASI
Bank Code: 64
Branch Name: PERPA
Branch Code: 1188
Beneficiary: ACADEMIA YASAM BILIMLERI MERKEZI LTD.STI
Swift Code: ISBKTRISXXX
Account No: 0177484(EURO)
Location of bank: Okmeydani/Sisli/Istanbul/Turkey
ABA Routing: Not applicable
IBAN #: TR270006400000211880177484 (EURO)

E-mail: info@academialsc.com
Fax: +90-212-210 5856
Contact Person: Aslıhan Yılmazoğlu, seminars@academialsc.com 
Addre: Academia Life Sciences Centre,
Perpa Tic. İs Merkezi B Blok, 5. Kat, No:480 Sisli, Istanbul, Turkiye
Call: +90-212- 210 5916 / +90 212 210 5914
Web:www.academialsc.com  

8 & 9 November 2010

08.00am Registration&Continental Breakfast
08.30am Course begins
10:00am Mid-morning Refreshment Break
10:30am Course Continue
12:30pm Luncheon
13.30pm Course Continue
15:00pm Mid-Afternoon Refreshment Break
15:30pm Course Continue
17:00pm Question&Answers
17:30pm End of the day

One person from 900.00 Euro/person (+%18VAT)

Two person from 810.00 Euro/person (+%18VAT)

Three person from 765.00 Euro/person (+%18VAT)

Registration Fee Includes;
Presentation Materials, Certificate of Attendance, Luncheon and Refreshments

Cancellations / Substitutions: Registration may be transferred to a member of the same organization at any time.  Please note that cancellations after October 08, 2010 will not be accepted. All cancelations are subject to a 100 Euro processing fee. Academia reserves the right to cancel an event. Academia is not responsible for any airfare, hotel, or other costs incurred by registrants. Speakers subject to change without notice.

Method of Payment: Please note that payment is required in advance of the conference. Please choice either with bank transfer or cheque that information given below. Confirmation of your registration will be sent. Registrations received without payment will not be processed.

Please make cheques payable to:

"Academia Yasam Bilimleri Merkezi Ltd.Sti"
Perpa Tic. Is Merkezi, B Blok, Kat:5, No:480 34384 Sisli, Istanbul, Turkiye

For Bank Transfers:
Bank Name: TURKIYE IS BANKASI
Bank Code: 64
Branch Name: PERPA
Branch Code: 1188
Beneficiary: ACADEMIA YASAM BILIMLERI MERKEZI LTD.STI
Swift Code: ISBKTRISXXX
Account No: 0177484(EURO)
Location of bank: Okmeydani/Sisli/Istanbul/Turkey
ABA Routing: Not applicable
IBAN #: TR270006400000211880177484 (EURO)

E-mail: info@academialsc.com
Fax: +90-212-210 5856
Contact Person: Aslıhan Yılmazoğlu, seminars@academialsc.com 
Addre: Academia Life Sciences Centre,
Perpa Tic. İs Merkezi B Blok, 5. Kat, No:480 Sisli, Istanbul, Turkiye
Call: +90-212- 210 5916 / +90 212 210 5914
Web:www.academialsc.com  

GMPs and SOPs in the Microbiology Laboratory tend to evolve as a spin-off of the analytical chemistry laboratory.  Likewise the facility is often pushed into the little space that is left after the QC lab has been assigned two or three larger rooms.  As a result there is often inadequate space to allow separation of “dirty” activities such as strain handling and growth promotion testing, from “clean activities” such as bioburden testing or water sample testing.  Process flows are often awkward and refrigerators, incubators and other storage areas double up for storage of sterile media, test samples prior to testing and bacterial slants awaiting use in growth promotion test.  Small wonder that production claim samples were “contaminated in the laboratory” or results were false positives.  This course will discuss possible design layouts for a laboratory as well as the need for differential pressures, also considering available alternatives such as the use of dedicated biological safety cabinets.

Essential topics

• Microbial Control Strategy for Production: product and process and for Microbiology Laboratory
• Separation of activities: “dirty” from clean
• Microbiology Laboratory design for successful workflow
• Focus on aseptic practices
• Disinfection and Sanitization
• Cleanroom and general laboratory operation to minimize false positives
• Risks posed to production by incorrect personnel practices within and outside the laboratory
• Microbial isolates: identification, strain maintenance and libraries
• Growth promotion testing: how to maximize the value of these tests

Learning Keys

• Become familiar with regulations and guidance in this critical field
• Understand why the Microbiology learned in universities is different to applied Microbiology in the pharmaceutical industry
• Learn about media controls to maximize microbial recovery
• Become familiar with disinfectants and understand the difference between cleaning and sanitization
• Learn why disinfectants fail
• Understand the role of the microbiologist in the laboratory and in educating colleagues outside the laboratory
• Understand how to handle microbiological data deviations
• Learn to conduct effective failure investigations
 

Karen Ginsbury, B.Pharm, M.Sc, MRPharmS

Has over twenty years of experience in the pharmaceutical industry.  With a Bachelor of Pharmacy degree from the University of London (“The Square”) and a Master of Science in Microbiology from Birkbeck College, University of London, Karen started off with a well-rounded foundation in the basic skills appropriate to the pharmaceutical industry.  She has worked in industry for most of her career, initially in Research and Development at Smith and Nephew in England and then for seven years at Teva Pharmaceutical Industries, today the world’s largest generic manufacturer.  After leaving Teva, Karen set up her own consultancy company, PCI Pharmaceutical Consulting Israel Ltd which has been providing services to the pharmaceutical industry worldwide for the past 14 years. 

PCI regularly works with pharmaceutical, biotech and API manufacturers to assist them in resolving compliance issues with regulatory authorities, in setting up, maintaining and upgrading or improving their quality systems, performing audits at vendors, contract manufacturers, laboratories as well as helping clients successfully prepare for FDA, Health Canada, EU and local regulatory inspections.Karen was responsible for setting up the compliance department at Teva and published a book on compliance auditing, still available in the USA, that was purchased by most of the multi-national pharmaceutical companies as well as by the US FDA.

Karen regularly lectures around the world on quality topics and is renowned for her lively and engaging style of presentation.  She was winner of the Institute of Validation Technology’s “Presentation of the Year Award” in 2006 and their “Webseminar of the Year Award” in 2007.

Karen is an active volunteer in the Parenteral Drug Association (PDA) and was awarded the 2008 Gordon Personeus award honoring a PDA member for his or her long-term acts or contributions that are of noteworthy or special importance to PDA.  Karen is currently co-editing the PDA Technical Report on GMPs for Investigational Products.
 

If you are working in the Microbiology Laboratory or have a supervisory role or work in Quality Assurance to audit and oversee the Microbiology Laboratory you cannot afford to miss this course.  The course will also be of particular value to engineers and maintenance personnel involved in the design of HVAC systems and layouts for facilities that include Microbiology Laboratories.  Production and operations personnel will benefit from understanding how the laboratories design, operation and maintenance serves their needs.

Ramada Plaza Istanbul,
Halaskargazi Cad. No:139-151, 34373 Osmanbey-Sisli – Istanbul – Turkey
Info & Reservation: +90-212-44 0 272
Tel: +90 – 212 – 315 44 44
Fax: +90 – 212 – 315 44 45
Web: www.ramadaplazaistanbul.com