Training for the Pharmaceutical, Biotechnology & … Biotech... Training for the Pharmaceutical, Biotechnology & Clinical Industries CfPA Courses Offer You: • Topics from Introductory

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Training for the Pharmaceutical, Biotechnology & Clinical IndustriesCfPA Courses Offer You:

• Topics from Introductory to Advanced• Best Practices from Leading Industry Experts• Informative and Interactive Environment that Encourages Learning• Application Oriented Real Life Case Studies• Hands-On Workshops that Provide the Practical Knowledge You Need

September -December 2007 European Course Catalog

Catalog Contents

For course information, go to www.cfpa.com

Title Date Location Page

ADME: Fundamentals of Absorption, 1-2 Oct. Amsterdam 1Distribution, Metabolism & Elimination

Analytical Methods Validation 22-24 Oct. Dublin 1for FDA Compliance

Calibration in the FDA Regulated Industry 24-25 Sept. Dublin 2

Drug Specification Development 15-18 Oct. Amsterdam 2for APIs and Drug Products

Early Stage Clinical Studies for Drugs 5-6 Nov. Amsterdam 3& Devices

Fundamentals of Biochemistry: 12-13 Nov. Amsterdam 3Background for Biotechnology

Good Laboratory Practices 26-28 Nov. Amsterdam 4

Introduction to Drug Delivery Technology 8-9 Oct. Amsterdam 4

PAT-Based Downstream Protein Purification 29-30 Oct. Hoofddorp 5

Process Analytical Technology (PAT) 24-25 Oct. Amsterdam 5

Scale-Up and Post Approval Changes 3-5 Dec. Amsterdam 6Guidelines (SUPAC & API Changes)

Science & Risk Based Approach to 24-25 Sept. Amsterdam 6Commissioning, Qualification & Validation

System Validation, GAMP Harmonization 22-24 Oct. Amsterdam 7and P.A.T.

Calendar of Courses 7

General Information 8

September - December 2007Courses for the Pharmaceutical, Biotechnology & Clinical Industries

NEW

WelcomeFor 40 years CfPA has been meeting theneeds of professionals in the pharmaceuti-cal, biotechnology, clinical and medicaldevice industries with the most compre-hensive selection of accredited technical training programs available anywhere. Our curriculum of over 450 courses in 19 industries cover basic to advanced topics in Regulatory, Quality Assurance,Manufacturing, and Research. Choose acourse from a variety of formats to fit your professional lifestyle: public, client-site or online.

Online TrainingCfPA’s Online Training program offers anew way to experience CfPA’s AccreditedTechnical Training and is the perfect com-plement to our public and client-site courses. Now you can easily access theknowledge you need through the Internet toimprove your performance on the job andincrease your value to your employer. Formore information and upcoming courses,visit our website at:

www.cfpa.com/onlinetraining orE-mail: [email protected]

Client-Site TrainingTake advantage of the benefits Client–Sitetraining offers: Cost effective, convenient,customized one-on-one attention. Anycourse in this listing can be brought to yourcompany and tailored to your specificneeds. For further information, please contact Client Site Programs:

732.238.1600 ext. 4549 or E-mail: [email protected]

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1For course information, go to www.cfpa.com

ADME: Fundamentals of Absorption, Distribution, Metabolism & Elimination ID: 2077 Offering #: 0710-106

1-2 October 2007 • Amsterdam, The NetherlandsWho Should Attend: This course is designed for a broad range of personnel in the pharmaceutical indus-try that need a basic understanding of ADME/pharmacokinetics, especially as pertains to drug develop-ment. It should be especially valuable for:

• Those needing a basic understanding of the processes involved in absorption and disposition of drugs • Managers of pharmacology and toxicology studies • Scientists that direct or evaluate pre-clinicalstudies • Chemists and other scientists involved in drug development • Biomedical engineers

Course Summary: The course will provide participants with an understanding of the principals and funda-mentals for absorption, distribution, metabolism, and the elimination (ADME) of pharmaceutical chemicals.The actual dose of a drug that ultimately reaches the target tissues and exerts pharmacologic or toxicologiceffects is highly dependent on the kinetics of drug absorption and disposition in the body. Many factors caninfluence these kinetic processes. The goal of the course is to provide training in the fundamentals of ADMEthat should be understood for those involved in drug development and clinical applications. The thrust of thediscussions will pertain to drugs, although the concepts are appropriate for all chemical entities. Some model-ing and mathematical formulations will be presented; however, the lack of mathematical background will notimpede one’s ability to understand the concepts involved. Finally, a few practical examples of the ADME ofdrugs will be provided to illustrate how the principles are applied in real life situations.

Course Director:Theodore M. Farber PH.D., DABT ToxaChemica, International, Inc. Former FDA Director, Drugand Environmental Toxicology Former EPA Director, Pesticide Toxicology.

Tuition:Early Registration (SAVE $200): U.S. $1,585 ($1,510 with Group Discount*) (Must register and pay by 6 August 2007)

Regular Registration: U.S. $1,785 ($1,710 with Group Discount*)

ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement(CfPA) is accredited by the AccreditationCouncil for Pharmacy Education as a providerof continuing pharmacy education. Continuing

Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially all the formal sessions and submission of a course evaluation. The CEU rate is 0.1 CEU per contact hour; statement of credit will be mailed within six weeks. You will have an oppor-tunity to evaluate your successful completion of these courseobjectives through a Learning Assessment. This offering isProgram# 716-000-07-490-L04

(Please refer to page 8 for full description of each Accreditation)

Analytical Methods Validation for FDA Compliance ID: 1887 Offering #: 0710-406

22-24 October 2007 • Dublin, IrelandWho Should Attend: This course is intended for individuals who have the responsibility for establishingthe integrity of analytical methods for active pharmaceutical ingredients (APIs) or finished pharmaceuticaldosage forms. This course will benefit individuals in:• R&D • Quality Control • Technical OperationsRegulatory affairs personnel responsible for the review of such data will also benefit from this course.

Course Summary: One of the most critical factors in developing and marketing pharmaceutical drugsubstances and drug products today is ensuring that the analytical methods used for analysis can gener-ate valid data upon which business and regulatory decisions can be made. FDA, ICH and USP have eachrecognized the importance of this to the drug development process and have separately expandedmethod validation requirements in recent years. However, with only limited guidance, industry has beenleft to interpret how to adequately comply with the regulations. Whether involved in method development, method validation, method optimization or method transfer,this course will provide a broad understanding and “hands-on” knowledge of the method validationprocess and the difficulties encountered in validating methods to comply with today’s upgraded FDACDER requirements. Lectures will include not only theoretical basis and practical applications, but actualvalidation examples of HPLC, GC, UV/Vis, AA, and titration methods for small organic molecules.Because of the tremendous effort that can be expended in conducting validation studies, efficiency ofexperimental design and documentation will be stressed throughout the discussions.Although the general principles in this course may be applied to methods for testing biological moleculesand medical devices, the focus of this course is on the validation of methods for the analysis of small molecules.

Course Directors:J. Mark Green, Ph.D. Principal Investigator, Bristol-Myers Squibb Medical ImagingDavid E. Wiggins Associate Director of Analytical/Stability R&D, Schering-Plough Consumer Health Care Products




Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially allthe formal sessions and submission of a course evaluation.The CEU rate is 0.1 CEU per contact hour; certificate will be mailed within six weeks. You will have an opportunity to evaluate your successful completion of these courseobjectives through a Learning Assessment. This offering is Program# 716-000-06-003-L04


Calibration in the FDA Regulated Industry ID: 2026 Offering #: 0709-407

24-25 September 2007 • Dublin, IrelandWho Should Attend: This overview course is intended for individuals in all industries, but specifically individuals in FDA regulated industries, who are responsible for establishing, maintaining, operating a calibration program, and audit of calibration activities, including:• Quality Assurance • Quality Control• Quality Engineering • Technical Support• Research and Development • Facilities and Equipment Maintenance

Course Summary: The regulations covering manufacture and control of drug products and medicaldevices require that firms have a program for the calibration of test and measurement equipment. A requirement for calibration is also defined in ISO 9000 and a quality system for a calibration laboratoryis described in ISO 17025. Calibration is a good business and science practice followed in all industriesthat require measurements for process monitoring and control. The program must include the elementsof: calibration intervals, scheduling, specific calibration procedures, limits of accuracy and precision andremedial action in the event that the instrument does not meet established requirements.This course addresses the regulatory and business requirements for calibration as an element of a QualitySystem and how these requirements support the increasing application of process monitoring andsophisticated laboratory instrumentation, along with the maturing discipline of calibration in the regulatedindustries. It includes a discussion of a compliant calibration program and concludes with a discussion of a model calibration procedure.

Course Directors:John (Jerry) Lanese, President, The Lanese Group, Inc.

Tuition:Early Registration (SAVE $200): U.S. $1,585 ($1,510 with Group Discount*) (Must register and pay by 30 July 2007)


2 For course information, go to www.cfpa.com

ACCREDITATIONS/CERTIFICATIONS

The Center for Professional Advancement(CfPA) is accredited by the AccreditationCouncil for Pharmacy Education as a providerof continuing pharmacy education. Continuing

Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially all the formal sessions and submission of a course evaluation.The CEU rate is 0.1 CEU per contact hour; certificate will bemailed within six weeks. You will have an opportunity to evalu-ate your successful completion of these course objectivesthrough a Learning Assessment. This offering is Program#716-000-07-305-L04


Drug Specification Development for APIs and Drug Products ID: 1918 Offering #: 0710-301

15-18 October 2007 • Amsterdam, The NetherlandsWho Should Attend: This course is intended for personnel from both Generic and Research-basedpharmaceutical industries including:

• Analytical and synthetic chemists from R&D • Regulatory Affairs Personnel • Pharmacists• Regulatory Affairs Personnel • Staff from production departments and from QA and QC• Pre-clinical scientists will benefit from the course by gaining a better understanding of the complexities

of the drug development process and of the importance of setting specifications

Course Summary: The course will present a review of the activities that will occur in the process of set-ting specifications for APIs made by synthesis or conventional fermentation. Critical specification issuesfor drug substances and drug products will be reviewed, specifically focusing on the interactions and dia-logue necessary between analytical and pharmaceutical/ chemical groups during the development ofspecifications. Using practical examples, the importance of understanding “real-life” constraints and regu-latory requirements will be highlighted across a wide variety of drug product formulations. Strategies forOut-Of-Specification (OOS) findings will be discussed. The course will review the latest activities of ICHwith respect to specifications for drug substances and drug products. You will benefit in your job by apply-ing facts learned in this course. Increases in productivity will result. An open and interactive environmentis encouraged throughout the course.

Course Directors:Goetz E. Hardtmann Ph.D., Senior Partner, H&H Consultants

Tuition:Early Registration (SAVE $200):

Days 1-3: U.S. $2,235 ($2,130 with Group Discount*) Days 1-4: U.S. $2,600 ($2,480 with Group Discount*) (Must register and pay by 20 August 2007)

Regular Registration:

Days 1-3: U.S. $2,435 ($2,330 with Group Discount*) Days 1-4: U.S. $2,800 ($2,680 with Group Discount*)


Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially allthe formal sessions and submission of a course evaluation.The CEU rate is 0.1 CEU per contact hour; statement ofcredit will be mailed within six weeks. You will have anopportunity to evaluate your successful completion of these course objectives through a Learning Assessment.This offering is Program# 716-000-06-172-L04



Fundamentals of Biochemistry: Background for Biotechnology ID: 33 Offering #: 0711-303

12-13 November 2007 • Amsterdam, The NetherlandsWho Should Attend: This is an introductory-level course for those interested in learning more about themolecular dynamics of living systems. It is intended for research, supervisory, scale-up or manufacture, and other technical operations personnelwith some scientific background who are and those involved in, or contemplating participation in:

• Biotechnology • Microbiology • Molecular Biology• Biomedical Engineering • Toxicology

Course Summary: Biochemistry pertains to the study of living systems at the molecular level andprovides a background appropriate for further work in the growing technologies of biochemical engineering,biotechnology, microbiology, toxicology and molecular biology. This course will focus on selected aspectsof biochemistry that provide the non-specialist with the principles for understanding the structure andfunction relationships of biomolecules including DNA, proteins, enzymes, carbohydrates, and monoclonalantibodies. Metabolic pathways, their regulation and control, the biocatalytic process, and laboratory andbioprocess separation techniques will be highlighted. Protein purification techniques will be utilized in a“hands-on” fashion using a computer program which simulates a test case of purification.

Course Director:Ronald A. Pepin, Ph.D., Senior Vice President Business Development, Medarex, Inc.

Tuition:Early Registration (SAVE $200): U.S. $1,585 ($1,510 with Group Discount*)(Must register and pay by 17 September 2007)





Early Stage Clinical Studies for Drugs & Devices ID: 2118 Offering #: 0711-201

5-6 November 2007 • Amsterdam, The NetherlandsWho Should Attend: This course will benefit those in the pharmaceutical, medical device and biologicsindustries especially:• Personnel in development and clinical evaluation• Scientists who have specialized in other areas and wish to master the basics of the regulatory and

technical requirements and challenges involved in clinical development• Regulatory and managerial personnel involved with planning project management and creation of

development and regulatory strategies• Personnel with limited development experience• Newly hired employees of established companies whose responsibilities include new products

evaluated in humans

Course Summary: This two-day course will give a comprehensive overview of the regulatory require-ments, design, conduct and analysis of FIM (first in man) studies of new drugs, biologics and medicaldevices in human beings. The participant will come away knowing what must be done and what cannotbe done for and in such studies and how these fit into the development process.

Course Director:Dr. Shayne C. Gad, Principle of Gad Consulting Services

Tuition:Early Registration (SAVE $200): U.S. $1,585 ($1,510 with Group Discount*) (Must register and pay by 10 September 2007)





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Good Laboratory Practices ID: 545 Offering #: 0711-504

26-28 November 2007 • Amsterdam, The NetherlandsWho Should Attend: This course is intended for all management within industry, government, academiaand/or contract biological testing facilities especially: • Scientists • Regulatory/Compliance Personnel • Those newly assigned GLP responsibilities• Quality Assurance Staff • More experienced personnel needing to update their knowledge

Course Summary: The main intent of this course is to review the requirements imposed by GoodLaboratory Practice (GLP) regulations for facilities engaged in, toxicology and product safety testing, prima-rily in animals and biological test systems. The responsibilities and functions of management, the StudyDirector, Principal Investigator and the Quality Assurance Unit (QAU) will be covered. Various proceduresfor meeting the requirements of the regulations will be presented.The lectures will be supplemented by a question and answer session conducted by the Faculty and byworkshops involving problem-solving exercises. The course will concentrate on OECD Good Laboratory Practice guidelines and their application in membercountries, particularly Europe. This will include recent developments regarding multi-site studies and theirpractical interpretation. Additionally there will be sessions relating to computer validation, particularly asrequired by FDA in their 21 CFR Part 11 documents.Emphasis will be placed on practical implementation of GLP and discussion including consideration of prob-lems that the participants bring to the course. Practical hints and recommendations for steps in the imple-mentation of GLP will be included.

Course Director:David Long, Consultant, Long & Associates International Consulting Ltd.

Tuition:Early Registration (SAVE $200): U.S. $2235 ($2,130 with Group Discount*)(Must register and pay by 1 October 2007)


ACCREDITATIONS/CERTIFICATIONSThe Center for Professional Advancement (CfPA)is accredited by the Accreditation Council forPharmacy Education as a provider of continuingpharmacy education. Continuing Education Units(CEU) will be awarded only upon successful

completion of the course, i.e., attendance at essentially all the formal sessions and submission of a course evaluation. The CEU rate is 0.1 CEU per contact hour; statement of credit will be mailed within six weeks. You will have an opportunityto evaluate your successful completion of these course objectivesthrough a Learning Assessment. This offering is Program# 716-000-07-134-L04


Introduction to Drug Delivery Technology ID: 2084 Offering #: 0710-204

8-9 October 2007 • Amsterdam, The NetherlandsWho Should Attend: The course should be of value to those new to this field or those working in specificareas that want to learn a broader perspective of drug delivery. This would include:

• Pharmaceutical Scientists • Patent Attorneys • Chemists • Business Development• Regulatory Affairs Personnel • Biologists • Engineers • Sales and Marketing

Technical and business staff that serve in contract research, analytical lab, and manufacturing environmentusing a broad spectrum of delivery technologies will derive significant benefit.

Course Summary: The program will provide an introduction to various drug delivery routes and describethe technologies that are used in each of these routes. Emphasis will be placed on methods developed inrecent history rather than the older techniques of pharmaceutical compounding and also on proven tech-nologies with results and actual applications rather than just research in this field. Each lecturer will presentareas where he or she is actively involved as well as the technologies from other companies working in thisfield. The lecturers, all recognized experts in their subjects with proven products in the marketplace, willpresent up-to-date information about their fields of specialty. The lectures are structured to encourage active participation among participants and lecturers

Course Director:Dr. Irwin Jacobs Director of Research and Development, Particle and Coating Technologies, Inc.

Tuition:Early Registration (SAVE $200): U.S. $1,585 ($1,510 with Group Discount*)(Must register and pay by 13 August 2007)



Education Units (CEU) will be awarded only upon successfulcompletion of the course, i.e., attendance at essentially all theformal sessions and submission of a course evaluation. TheCEU rate is 0.1 CEU per contact hour; statement of credit will be mailed within six weeks. You will have an opportunity to evaluate your successful completion of these course objec-tives through a Learning Assessment. This offering isProgram# 716-000-07-650-L04



PAT-Based Downstream Protein Purification ID: 2130 Offering #: 0710-507

29-30 October 2007 • Hoofddorp, The NetherlandsWho Should Attend: This two-day course is designed for chemists, biologists and scientists involvingdevelopment, formulation and downstream purification of proteins. The course will benefit individuals in:• Quality Control • Regulatory Affairs • Formulation • Production • R&D

Course Summary: Chromatography is a very versatile technique frequently employed by scientists andresearchers in academia and in biotechnology. Different modes of chromatographic separation togetherwith practical tips on downstream purification of proteins will be discussed. Course participants will learnto develop analytical methods, to pack a cost-effective process column and to identify a PAT-based LCsystem aggressively promulgated by FDA. At the end of this course, you will understand how to optimizeprocess analytical technology (PAT)-based production of biopharmaceuticals and the process economicsinvolved.

Course Director:Michael K. Li, Ph.D., Biopharmaceutical Process Consultant

Tuition:Early Registration (SAVE $200): U.S. $1,585 ($1,510 with Group Discount*) (Must register and pay by 3 September 2007)




Process Analytical Technology (PAT) ID: 2085 Offering #: 0710-401

24-26 October 2007 • Amsterdam, The NetherlandsWho Should Attend: This comprehensive PAT workshop will benefit professionals who are involved in thedevelopment, testing and production of pharmaceutical, OTC, fermentation and biopharmaceutical products,including:• PAT Team Leaders • Analytical Managers • Pharmaceutical QA Personnel• Dosage • Instrument makers • Manufacturing Operations Personnel• Formulators • Excipient suppliers • Industrial Pharmacists• Managers tasked with improving the pharmaceutical business climate

Course Summary: Both the US Food and Drug Administration and the European Medicines Agency arepushing improvements in pharmaceutical manufacturing efficiency, defined as Process Analytical Technology,or PAT. These initiatives are driven by increased regulatory demand, consumer pressure and soaring drugdosage costs. The regulatory agencies have identified the test-to-document requirements of the old cGMPmandates as root causes for poor efficiency.This course establishes a baseline view of pharmaceutical manufacturing and examines PAT from industrial,regulatory and consumer viewpoints. Using case studies, the program demonstrates strategies that helpmanagement acceptance and support of PAT programs and provides tactics to avoid pitfalls.Detailed guidelines for PAT Team formation and management include a five-step plan with milestones. PATlaboratory and testing workflow, with reference to in-process monitoring will help participants transit from theory to practice. Several instrument and sensor segments help form a PAT toolbox, as does a review ofchemometrics and statistical analysis. These segments are followed by a PAT validation unit.At the conclusion of the course, all participants will have a solid grounding in PAT program implementation.

Course Director:John E. Carroll, C.Ph.C., President, Carroll Ventures, Inc. Managing Partner, Cadrai LLC.








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Scale-Up and Post Approval Changes Guidelines (SUPAC & API Changes) ID: 1948 Offering #: 0712-106

3-5 December 2007 • Amsterdam, The NetherlandsWho Should Attend: This course is intended for personnel in the pharmaceutical industry involved in thedevelopment of drug dosage forms including:• Process Development • Technical Service • Pilot Plant • Quality Assurance• Regulatory Affairs • Research & Development • ProductionIt will also be of value to personnel wanting a comprehensive understanding of FDA guidelines andrequirements relevant to changes in formulation, equipment and process in the following fields:• Analytical Services • Product development • Production • Quality Assurance• Project Management

Course Summary: This course will provide a basic understanding of the FDA Scaleup and PostApproval Changes Guidelines & the recent 2004 guideline on Changes to approved NDA or ANDA. This also addresses the impact of withdrawal of the FDA BACPAC I guideline on changes in API synthe-sis. The issues affecting batch size scaleup/ scale-down, various post approval formulation component orcomposition changes, site of manufacturing changes, manufacturing process changes, and/or equipmentchanges will be addressed along with the issues affecting analytical methodology, packaging and labelingchanges. The course will focus on: The criteria that determines the level or degree of change; The type of study data or information that must be generated to support changes at each level; The FDA recom-mended chemistry manufacturing & control tests to support each level or degree of change; The type of in-vivo or in-vitro testing required to support the various levels of degrees of change. Case examples will be employed to allow the students to determine the type of data that are required to support the level of changes proposed.

Course Director:Mukund "Mike" Yelvigi, Director, Development Planning Chemical and Pharmaceutical Development, Wyeth Research Laboratories

Tuition:Early Registration (SAVE $200): U.S. $2,235 ($2,130 with Group Discount*) (Must register and pay by 8 October 2007)






Science & Risk Based Approach to Commissioning, Qualification & Validation ID: 1954 Offering #: 0709-406

24-26 September 2007 • Amsterdam, The NetherlandsWho Should Attend: This advanced course is designed for individuals responsible for validation, commis-sioning, construction, or design who need a thorough understanding of the Validation and CommissioningProcess for approved pharmaceutical/biopharmaceutical manufacturing facilities. The course will benefitindividuals in:

• Engineering • Regulatory Affairs • Technical Services/Validation• Production • Quality Control/AssurancePharmaceutical Industry Service Providers will also find this course beneficial.

Course Summary: Because validation is the critical factor in achieving FDA approval of new and reno-vated facilities, it is essential that validated systems and equipment be commissioned using GEP in amanner to facilitate the validation process.This course will cover what has become the traditional approach to conduct Qualification and Validation,and will also show how that approach supports the new Regulatory Science and Risk Based Approach forthe 21st Century. Current industry application of the impact assessment process for utility systems andequipment will be covered, and assessment results on Master Plans will be explained. The course demon-strates the importance of applying Good Engineering Practice in the preparation of design specifications,conducting design qualification, and correctly establishing contractor responsibilities for adherence tothese specifications during construction and installation.The course will show the relationship of all the steps in commissioning to the project life cycle. Necessaryelements will be explored in detail to assure a successful integrated commissioning qualification effort.Examples will be used to provide guidance for development of sound commissioning and validation pro-grams resulting in reduction of cost and time of 10%-20%.

Directed by:Steven Wisniewski, Senior Associate and Director of Compliance, Integrated Project Services (IPS)

Tuition:Early Registration (SAVE $200): U.S. $2,235 ($2,130 with Group Discount*) (Must register and pay by 30 July 2007)





For course information, go to www.cfpa.com 7

System Validation, GAMP Harmonization and P.A.T. ID: 913 Offering #: 0710-403

22-24 October 2007 • Amsterdam, The NetherlandsWho Should Attend: This three-day, practical course will be of interest to professionals in thePharmaceutical, Biopharmaceutical and other FDA regulated industries. This includes but isn’t limited to:• Automation Managers/ Directors • Validation Engineers • Systems Administrators• Technical Support Personnel • QA/QC Personnel • User Support Staff

Course Summary: This course is intended to be an overview of the latest emergent issues of FDA com-pliance, including: Process Analytical Technology (PAT); computer system validation; risk assessment; 21CFR Part 11; and harmonization with GAMP4. Now that computers have replaced many of the manualoperations associated with the acquisition and management of information, it is important to ensure thatappropriate testing and control procedures are applied to the new systems. This course will cover the avail-able techniques for verifying that computer systems function as they are intended to. In addition, the role ofprocedures and documentation will be presented.The computer industry has, for some time, been developing validation procedures for systems; however,many of these techniques have not been presented in the context of international regulations. This coursewill address the emerging trends based on industry experience, including results from recent findings in FDAcomputer system audits. There are specific times set aside to discuss establishing such a validation pro-gram in participants’ respective organizations.

Course Director:Dr. Sandy Weinberg, Vice President, Regulatory Affairs Tikvah Therapeutics

Tuition:Early Registration (SAVE $200): U.S. $2,235 ($2,130 with Group Discount*)(Must register and pay by 27 August 2007)





Additional September-December 2007 CoursesID No. Course Title Location Dates

677 Industrial Membrane Separations Amsterdam 24-27 September

2131 ICH Q10: Pharmaceutical Quality System Amsterdam 27-28 September

610 Applied cGMPs for the Pharmaceutical and Allied Industries Amsterdam 1-3 October

1836 Current Good Manufacturing Practice (cGMP) for Purchasing Amsterdam 1-2 October

767 Industrial Drying of Heat Sensitive Materials Amsterdam 8-10 October

2030 PAT Online Process Analysis Amsterdam 8-10 October

1114 Managing Multiple Projects in a Resource-Limited Environment Amsterdam 10-12 October

561 Process Plant Start-Up Amsterdam 15-18 October

1025 Industrial Rheology Den Haag 16-18 October

2047 Laboratory Control Systems Amsterdam 31 October -2 November

224 Pharmaceutical Quality Assurance and Control Amsterdam 5-9 November

448 INDs, NDAs vs CTDs Global Regulations Amsterdam 5-7 November

1116 Biopharmaceutical Process Systems Amsterdam 12-14 November

2089 Root Cause Investigation for CAPA Amsterdam 12-13 November

129 Effective Project Management Amsterdam 13-15 November

1774 Auditing & Inspecting Preclinical Research for GLP Compliance Amsterdam 21-23 November

1867 Critical Process Cleaning and Cleaning Validation Dublin, Ireland 28-30 November

1808 IQ, OQ, PQ Amsterdam 29-30 November

2091 ICH-Q7A Amsterdam 3-4 December

2095 Pharmaceutical Technology Transfer Amsterdam 5-6 December

2137 Laboratory Analysis in Clinical Trials Amsterdam 10-11 December

2136 The GLP Study Director Amsterdam 12-14 December

599 Drug Product Stability and Shelf-Life Amsterdam 17-19 December

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Accreditations/Certifications

The Center for Professional Advancement hasbeen reviewed and approved as an AuthorizedProvider (#640) of continuing education andtraining programs by the InternationalAssociation for Continuing Education and

Training (IACET). Continuing Education Units (CEU) will be awardedfor participation in this course at a rate of 0.1 CEU per contact hour.CEU will be awarded only upon successful completion of the course,i.e., attendance at essentially all the formal sessions and submission of a course evaluation.

This course has been approved for recertification credits bythe AACE International Certification Board toward meetingthe continuing education requirements for recertification asa Certified Cost Engineer, Certified Cost Consultant,Planning and Scheduling Professional and Earned ValueProfessional.

Locations

Dublin, Ireland:Radisson SAS St. Helen’sStillorgan Road, Dublin 4, EIPhone: +353/1/218.6000Fax: +353/1/218.6010

The Center for Professional Advancement (CfPA) isaccredited by the Accreditation Council for PharmacyEducation as a provider of continuing pharmacy education.Continuing Education Units (CEU) will be awarded only

upon successful completion of the course, i.e., attendance at essentiallyall the formal sessions and submission of a course evaluation. The CEUrate is 0.1 CEU per contact hour; certificate will be mailed within sixweeks. You will have an opportunity to evaluate your successfulcompletion of these course objectives through a Learning Assessment.

ASQ Certification: ASQ Certified Quality Engineers,Reliability Engineers and Quality Auditors may earnrecertification credits for attending this program, providing it is covered under one area of the body of knowledge inwhich they are seeking recertification or is jobenhancement.

Amsterdam, The Netherlands:NH Amsterdam Centre HotelStadhouderskade 71054 ES Amsterdam, TheNetherlandsPhone: +31/20/685.13.51Fax: +31/20/685.16.11

Park Plaza Victoria Amsterdam HotelDamrak 1-51012 LG Amsterdam, The NetherlandsPhone: +31/20/62.34.255Fax: +31/20/62.52.997

A limited block of rooms in the hotel will be held for our registrants until four weeks before the course. Participants must, however, make their own reservations; the cost of hotel accommodation is not included in the course fee.

To receive CfPA's rate and room block, be sure to mention that you will be attending one of our courses.

Hoofddorp, The Netherlands:Courtyard by Marriott–Amsterdam AirportKruisweg 14012131 MD Hoofddorp, NLPhone: +31/23/556.9000Fax: +31/23/556.9009

CfPA holds 13 Accreditations. The following are available for the selected courses in this catalog. For more informationon all of our Accreditations/Certifications visit our website at www.cfpa.com.

CfPA courses on pages 1-7 are held in the following hotels. Please refer to individual course for appropriate location.

Terms and ConditionsTuition payable in US funds net of all charges includes luncheon, breaks and course notes. Payment is due prior to course start date. If payment has not been received two weeks before the course, a credit card will be required to guarantee admittance.

Discounts: Early registration discount requires payment at time of registration and before expiration or regular tuition will apply. *Group Discount is for two or more enrollments registering at the same time, from the same company, for the same course.Cancellations/Substitutions: All cancellations are subject to a $150.00 processing fee. Applicants may cancel up to two weeks prior to the course start date for a refund. If less than two weeks, a credit will be issued that can be used towards a future course up to one year from the date of issuance. No refunds or credit will be issued for those who do not attend the scheduled course and/or cancel less than two working days before the start date. Substitutions are permitted at any time. If for any reason, CfPA decides to cancel this course, we are not responsible for airfare, hotel or othercosts incurred by the registrant. Program content, schedule and instructors are subject to change without notice.Confirmation Letters: Before each course begins, all registrants will receive written confirmation including detailed information regarding course location. If confirmation is not received two weeks prior to the course please contact us.For those requiring visas, confirmation letters will not be sent until payment is received.

Please note: English will be used in all lectures and course notes.

For our full terms and conditions, visit www.cfpa.com.

General Information

Crowne Plaza Amsterdam City CentreNieuwezijds Voorburgwal 51012 RC Amsterdam, The NetherlandsPhone: +31/20/620.05.00Fax: +31/20/620.11.73

Renaissance Amsterdam Hotel Kattengat 11012 SZ Amsterdam, The NetherlandsPhone: +31/20/621.2223Fax: +31/20/627.5245www.renaissancehotels.com

9For course information, go to www.cfpa.comID: 2148 - Offering: 0705-803 - BID: C7-110

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CfPA’s Online Training is a perfect complement to our public and client-site programs. Experience the ability to supplement your training needs or expand on your knowledge in areas critical to your job function.

Advantages of CfPA’s Online Training:Convenient – Access CfPA Online Training from your office, home or on the road - anywhere around the world

Interactive – Actively participate with instructor and participants in a virtual classroom through the use of polls, Q&A and other online tools

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Easy to Use – All you need is a computer with an internet connection, and a phone line

Cost Effective – Save on travel costs and time out of the office

Webinars:In addition to our 90 minute Online Training programs, CfPA will be offering hour long “Info Bursts” on the latest news, regulationsand/or technologies in the pharmaceutical, chemical and cosmetic industries.

For 40 years CfPA has been delivering high quality, pragmatic training programs to professionals like you around the world. Now youcan easily access the knowledge you need to improve your performance on the job and increase your value to your employer.

For more information on our Online Training and Webinars:Visit our website at www.cfpa.com/onlinetraining

Customized Training ThroughClient-Site ProgramsWhatever your on-site needs may be, we can meet them.

Offered at your location and at your convenience, CfPA will bring any course to your team for customized training, or we can work with you to develop a program to address the specific issues most critical to you.

What are the advantages to a Client-Site Course?

• You can have up to thirty-five of your engineers, scientists and technical managers participating simultaneously in a course.

• You have the opportunity to tailor the standard program to your company’s specific problems and interests.

• You have one-to-one access with a top teaching team specializing in your industry, and comprehensive course material, for an all-inclusive fee.

• You save on costly hotel and travel expenses.

How to arrange a Client-Site Course:If your company is interested in a Client-Site training program, please contact our Client-Site division at 732.238.1600 ext. 4549 or E-mail [email protected].

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nn Send Invoice (POs must be revieved in advance of course) nn Check: Payable in US funds to: The Center for Professional Advancement

nn Bank Transfer (Pay by Bank Transfer to Account No. 62.62.46.628 at ABN-AMRO Bank N.V., Postbus 407, 1000 AK Amsterdam, The Netherlands. The course offering number and participant's name must be included on bank transfer.)

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Instructions:Please complete Registrant Information, Course Information andPayment Sections.Submit one form per individual registrant.

Check here if group discount applies (two or more enroll-ments for the same course, from the same company).

ONLINE: www.cfpa.com FAX: MAIL:(Please Use Priority Code Below) +31.20.620.21.36

The Center for Professional Advancement (CfPA)Oudezijds Voorburgwal 316A • 1012 GM Amsterdam, The Netherlands

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September - December 2007European Course CatalogCfPA Courses Offer You:

• Informative & Interactive Topics• Industry Expert Instructors• Case Studies & Workshops

www.cfpa.com

Training for the Pharmaceutical,Biotechnology & Clinical Industries

Documents

Training for the Pharmaceutical, Biotechnology & … Biotech... Training for the Pharmaceutical, Biotechnology & Clinical Industries CfPA Courses Offer You: • Topics from Introductory