What You Will Receive with Your Web Seminar Purchase:
Access to the LIVE EVENT , a PDF Copy of the Presentation Slides,
Plus a Certificate of Attendance. Group registration includes five distinct live event logins.

September 3, 10 , 17, 24 and October2
Check your local time against the times above.
NOTE: that Washington D.C. is representative of ET (Eastern Time).

TOPIC: Validation Basics From A - Z
Presenter: Gamal Amer, Ph.D., Principal, Premier Compliance Services, Inc.

This five event series will cover all validation basics. You can purchase one event or attend all five and receive a 10% discount.

1. Master Planning for Validation, September 3, 2008

2. Critical Documentation Requirements for Successful Validation, September 10, 2008

3. Validation Protocol Development and Acceptance Criteria, September 17, 2008

4. Validation Protocol Execution and Addressing Deviations, September 24, 2008

5. Validation and Change Control: The Validation Life Cycle, October 2, 2008

View full details & register online

---

Spectroscopy is pleased to presents this informative web seminar:
Tuesday, September 9, 2008 from 11am-12pm ET
Check your local time against the times above.
NOTE: that Washington D.C. is representative of ET (Eastern Time).

TOPIC: Spectroscopic Identification of Raw Materials for Pharmaceutical and Nutritional Supplement Industries
Presenter: Frederick H. Long, Ph.D., President, Spectroscopic Solutions, LLC

The identification of raw materials is an important quality issue for both the pharmaceutical and nutritional supplement industries. The US FDA has recently mandated that nutritional supplement companies verify the chemical identity of incoming raw materials. The cost of raw material testing using traditional wet chemical methods can be high in terms of both money and time. Spectroscopic methods such as NIR, FT-IR, and Raman are a scientifically valid and cost effective method for raw material testing. New spectrometer technologies are making spectroscopic testing an attractive alternative. The quantitative testing of raw materials will also describe. This seminar will review the scientific and regulatory issues in this area. The advantages and disadvantages of different technologies will be discussed.

View full details & register online

---

 Friday, September 26, 2008 from 11am to 12pm ET
Check your local time against the times above.
NOTE: that Washington D.C. is representative of ET (Eastern Time).

TOPIC: Developing and Validating Dissolution Test Procedures
Presenter: Michael E. Swartz, Ph. D., Research Director, Synomics Pharmaceutical Services

In-vitro dissolution performance tests for oral dosage forms, such as tablets and capsules, are used to assess the lot-to-lot quality of a drug product, guide development of new formulations, and to ensure the product quality and performance after changes in the manufacturing process, e.g. moving to a different site and/or scale-up. Like any performance test performed in a regulated environment, the dissolution procedure must be properly developed and validated. This seminar discusses the general concepts and highlights some specific method validation guidelines used in developing and validating dissolution test procedures using both UV and HPLC for sample analysis.

View full details & register online

---

Spectroscopy is pleased to presents this informative web seminar:
Thursday, October 9, 16 and 23, 2008 from 12pm to 1pm ET
Check your local time against the times above.
NOTE: that Washington D.C. is representative of ET (Eastern Time).

SERIES TITLE: Introduction to Chemometrics and Multivariate Analysis (MVA)
Presenter: Frederick H. Long, Ph.D., President, Spectroscopic Solutions, LLC

Spectroscopic methods such as NIR, FT-IR, and Raman are a scientifically valid and cost effective method for raw material testing. New spectrometer technologies are making spectroscopic testing an attractive alternative. The quantitative testing of raw materials will also be described. This seminar will review the scientific and regulatory issues in this area. The advantages and disadvantages of different technologies will be discussed.

This three part series of web seminars will cover the essentials of chemometrics: principal component analysis (PCA), partial least squares (PLS) and classification. Real world examples of MVA will be illustrated throughout the course. These seminars are intended for pharmaceutical professionals, who need a convenient way to learn about multivariate analysis. This series of web seminars assumes the attendee has only limited experience with statistics and spectroscopy.

View full details & register online

---

Pharmaceutical Technology is pleased to presents this informative web seminar:
Wednesday, October 22, 2008 from 11am - 1pm ET
Check your local time against the times above.
NOTE: that Washington D.C. is representative of ET (Eastern Time).

TOPIC: Understanding the Standard Setting Process of the United States Pharmacopeia and National Formulary Part 1 & 2
Presenter: Susan Schniepp, President, Schniepp and Associates

This training series will focus on the standard setting process of the United States Pharmacopeia and National Formulary. This complex process will be broken down into individual elements so the student can understand how the process works, how it impacts their work and how they can participate in the process. In addition, the series will also explore common misinterpretations of the USP General Notices, dissecting a monograph and validation and verification concepts for the methods in the USP/NF.

The USP has a number of processes that relate to the setting of standards for the United States pharmaceutical market. These processes included the USP Convention, Resolutions, Public Comment, and Monograph Submission.

View full details & register online

---

Wednesday, October 29, 2008 from 11am - 12pm ET
Check your local time against the times above.
NOTE: that Washington D.C. is representative of ET (Eastern Time).

TOPIC: Regulatory Strategies to Accelerate First in Man Studies
Presenter: Richard E. Lowenthal, MS MSEL, President, Pacific-Link Consulting

This seminar will focus on Regulatory strategies to accelerate first in man studies during early drug development. The discussion will provide some insight on several successful strategies for initiating first in man studies, including Exploratory INDs, regional flexibility and indication based strategies. Case studies for several approaches to initiating first in man studies in an accelerated fashion will be presented.

View full details & register online

---

Tuesday, November 4, 2008 from 11am - 12pm ET
Check your local time against the times above.
NOTE: that Washington D.C. is representative of ET (Eastern Time).

TOPIC: Computer Validation - what is important?
Presenter:Flemming Simonsen, Senior Director - Global QA, G(IT)P at Ferring Pharmaceuticals

The presentation will focus on how to perform a validation project for a computer system in a GxP environment, what are the validation requirements, how to implement and fulfill the requirements and finally definition of what validation documentation is needed to have in place.

Computer validation includes a lot of activities, so what is important to focus on - an initial assessment of the computer system is the first to be performed. The assessment should focus on the GXP Criticality, the applicability of 21 CFR Part11 and the assessment of the GAMP Software Category.

Based on the result of the assessment the required validation deliverables and activities can be defined.

The presentation will cover the main topics:

* Definition of validation
* Computer system assessment
* What are the required validation activities
* How to document the performed validation
* What is needed to maintain the validated state

View full details & register online

These are interactive seminars created by IVT. They can be attended by anyone with a modern computer and broadband access (LAN, DSL or Cable). Audio and video are delivered simultaneously via computer. 

Attendees sign on via their computers and can see an online slide show with an expert presenter just as though they were at an in-person conference.  In addition, there is a question and answer session, interactive polling, video capability, and follow up handouts.  

 IVT web seminars provide conference-quality content and industry-leading speakers and yet can be attended from the convenience of a home or office. Topics scheduled include residue limit calculations, software validation and vendor qualification among others.

---

SERIES TOPIC: FDA Inspections: Learning from the Experience of Others -- PART 1 - What to Expect Presented by Gamal Amer, Ph.D. Part one will address the FDA process of risk-based inspection, types of inspections, and the system based inspection. The presentation will begin by briefly reviewing the various types of GMP inspections and who from the agency will be present. We will then review the criteria the FDA uses to define their inspection target, the frequency of inspection and the timing of such inspections. The presentation will then focus on the “System Based Inspections” normally conducted by the FDA. In order to understand the system based inspections we will first define what the FDA will look for in each system, review many examples of FDA 483 observations, relate them to the various systems and finally we will emphasize the issues of most concern to the regulators. ORDER EVENT CDs (Flash Interactive CD)

SERIES TOPIC: FDA Inspections: Learning from the Experience of Others -- PART2 - How to Prepare Presented by Gamal Amer, Ph.D. Part two will address how to prepare for an inspection, how to address and respond to FDA findings, and finally how to avoid further regulatory action. It is incumbent on the healthcare product manufacturer to always be in compliance with GMP requirements and be prepared for regulatory inspections. Armed with the information gleaned from the first presentation we would define several steps to be taken by the manufacturer to prepare for FDA inspections. Additionally we will review in broad terms how to insure that you are in compliance and ready for such inspections at all times. ORDER EVENT CDs (Flash Interactive CD)

SERIES TOPIC: Advanced Topics in LC Method Validation This is a 6 CD collection. Presented by Dr. Michael Swartz explores advanced topics including instrument qualification, robustness, method transfer, investigating out of specification results and adopting new technology. This seminar is aimed at Directors, Lab Managers, and Practicing Chemists in regulated laboratories responsible for designing or implementing method validation protocols with an LC focus. ORDER EVENT CDs (Flash Interactive CDs)

SERIES TOPIC: Validation Basics A-Z: Planning, Implementing & Maintaining This is a 5 CD collection. Presented by Dr. Gamal Amer. Master Planning for Validation, Critical Documentation Requirements for Successful Validation, Validation Protocol Development and Acceptance Criteria, Validation Protocol Execution and Addressing Deviations, Validation and Change Control: The Validation Life Cycle ORDER EVENT CDs (Flash Interactive CDs)

Live event was held on: April 10, 2008 TOPIC: A Statistical Basis for Quality by Design Quality by Design is part of the FDA's 21st initiative and encompasses Process Analytical Technology, PAT, and ICH Q8, Pharmaceutical Development. Both PAT and Q8 make numerous references to using scientific and engineering principles along with a variety of terms that include mechanistic understanding, multi-factorial relationships, multivariate data acquisition, statistical design of experiments, response surface methodologies, methodological experiments, orthogonality, one-factor-at-a-time experiments, robustness, and interactions. This talk will address the fundamental concepts underlying these terms while reveling the hidden meanings behind the jargon. This is a non-mathematical introduction to the basic concepts using several case studies from published literature. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: September 27, 2007 TOPIC: Current FDA Thinking on Computerized Systems in Clinical Investigation This is a new FDA Guidance on Computerized Systems used in clinical investigation. This guidance complements the earlier Electronic Record and Electronic Signature FDA Guidance on 21 CFR Part 11. There are new items that must be considered if using automated systems for patient data collection. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: August 29, 2007 TOPIC: cGMP Informatics - IT Infrastructure Design for 21st Century Pharmaceutical Quality Control and Quality Assurance Operations This web presentation will outline a new three tiered IT infrastructure for cGMP quality operations. Key to this structure is the implementation of a "thin LIMS" coupled with a GMP Electronic Notebook System. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: August 23, 2007 TOPIC: A Comprehensive Approach to the Facilities and Equipment Subsystem of QSIT This presentation will discuss the different system options for a comprehensive approach to the Facilities and Equipment Subsystem of QSIT and provide some guidance on how to choose the option that is most appropriate for each company. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: August 7, 2007 TOPIC: Risk Based Approach to cGMP Systems This presentation will discuss the application of Risk Assessment to example process systems. Explore the application of risk as embodied with the term commissioning and qualification. Demonstrate a fundamental process used by industry to assess risk and make rational and documented decisions for the application of risk with the intent of shortening the qualification process and reducing overall project costs. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: July 6, 2007 TOPIC: Handling Deviations in the Microbiological Laboratory Microbiological testing takes an increasingly large slice of the resource pie in both sterile and non-sterile pharmaceutical manufacturing today. FDA has issued a comprehensive guidance document on handling chemical Out of Specification results, but has been almost silent on the topic of microbiological results. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: June 28, 2007 TOPIC: Trend Data This seminar covers the several aspects of trending pharmaceutical data. Beginning with a seven part definition of trending, the session details the four components of a trend and addresses statistical process control, engineering process control, beneficial, adverse and neutral trends. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: June 25, 2007 TOPIC: Cleaning Validation Strategies for Success: Grouping and Bracketing of Products and Equipment Cleaning validation can be a daunting prospect if minor changes result in the need to revalidate all possible combinations of products and equipment. Grouping or bracketing related products and equipment are an invaluable approach to ensure cleaning validation success, while permitting an appropriate risk-based focus on the most challenging combinations of products and equipment. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: June 20, 2007 TOPIC: Cleaning & Cleaning Validation: An Overview This web seminar will present a general overview of the cleaning process for equipment and facilities in the pharmaceutical industry. The regulatory requirements for a cleaning SOP will be defined by reviewing several examples of FDA 483 notices of adverse findings given to companies in the industry. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: June 14, 2007 TOPIC: Commissioning and Qualification Risk Assessment Commissioning of systems and equipment within the pharmaceutical industry in the USA has become an industry standard. While the intent of the practice was to streamline as well as cut the cost associated with qualification process, it has also become entangled in the documented evidence web of cGMP compliance. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: May 31, 2007 TOPIC: Managing International FDA Inspections The event will cover the phases of a typical international FDA Inspection and introduce techniques and tips to ensure you manage the inspection in an effective manner to represent you (or your partner's) facility in the best possible light. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: May 17, 2007 TOPIC: Pay Now or Pay (More!) Later: Optimizing the Computer Systems Maintenance Phase The events focus is on how to make the maintenance phase of a regulated computer system as efficient and inexpensive as possible, based on the implementation of good practice in earlier life cycle phases. In today’s environment of budget constraints and ongoing change, it’s as important as ever to ensure that funding used to maintain a computer system is money well spent. These strategies and approaches can help ensure that it is. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: May 3, 2007 TOPIC: The New Process Validation FDA Perspective - Basis for the Revision to the 1987 FDA PV Guideline The current focus on the commercial process "validation" will be shifted towards the design phase in agreement with the new FDA science-based approach, the application of Quality by Design by gathering complete product/process knowledge, a "continuous quality verification system" and an effective monitoring/assessment program to address effective process control and continuous improvement as the key factors for reducing the risk to the product quality. The presentation will explain these new concepts and how this new perspective is different from the current PV approach. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: April 30, 2007 TOPIC: How to Handle OOS Stability Results-When Do You Need to Alert the Regulators? Join industry expert, Karen Ginsbury, President, PCI Pharmaceutical Consulting Israel Ltd, as she provides an outline of regulatory expectations for handling OOS stability results and when and how to inform the regulators. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: April 19, 2007 TOPIC: Proper Documentation and SOPs to Ensure Compliance in the Lab Mr. Gaurav Walia, M.S., will focus on explaining why proper documentation is vital in the pharmaceutical business. Also, Mr. Walia discusses various types of SOPs and their importance (e.g., procedural, instrument, facility, etc.) while also demonstrating how to create an effective and compliant SOP system. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: April 12, 2007 TOPIC: Acceptance Criteria and Test Method Validation Current industry practice and good science require the method develop analyst define acceptance criteria in the method validation protocol. Establishing appropriate acceptance criteria is a challenge to the development chemist. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: April 4, 2007 TOPIC: CAPA: A Risk Mitigating Quality System The approach will focus on defining the specific steps to be taken when implementing a CAPA system and review some of the possible pitfalls one may encounter when implementing a CAPA system. We will also review some of the benefits which may accrue by having a robust CAPA system in place. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: March 30, 2007 TOPIC: Writing Scientific Rationales for Cleaning Validation: Balancing Risk and Regulation In this web seminar the numerous types of scientific rationales for cleaning validation will be discussed along with strategies for risk-ranking and documentation of decision-making in cleaning validation. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: March 28, 2007 TOPIC: Developing and Validating LC Stability Indicating Assays This presentation outlines how forced degradation is used to develop a SIM, and examines some of the method development and validation parameters critical to its success. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: March 14, 2007 TOPIC: ISO 14971 and Q9 Risk-based Validation Planning This web seminar will allow participants to evaluate a risk-based approach to corporate validation planning, and subsequent execution, to accomplish the most meaningful activities within very real-world constraints. It is designed for QA/RA. QAE, R&D, manufacturing and product engineering, production and validation team members, staff, and management. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: March 8, 2007 TOPIC: Proper Design and Maintenance of GMP Training Program with Emphasis on New FDA and Industry Trends The FDA expects pharmaceutical companies to have standard operating procedures defining their GMP training programs. Depending on the company, each SOP will be relevant to that business and their laboratory practices. Mr. Gaurav Walia, M.S., will focus on explaining the GMP requirements for training programs of laboratory personnel. . ORDER EVENT CD (Flash Interactive CD)

Live event was held on: February 28, 2007 TOPIC: Site Validation Master Planning This seminar will point out the best way to enhance the Validation Master Plan with impending regulatory review. It will be presented by Lou Angelucci, Associate Director for Quality Assurance with Bristol Myers Squibb Co. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: February 22, 2007 TOPIC: Forming a Partnership Between IT and QA: How to Achieve IT Quality the Right Way This seminar, conducted by Barbara Nollau, an internationally recognized expert in computer validation, quality/compliance and Part 11, will focus on the relationship between IT and QA. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: February 14, 2007 TOPIC: Quality Systems and Risk Management: A Multi-national Approach This seminar will allow you to reassess your approach to quality or to benchmark and ensure that your system meets current expectations. Join industry expert, Karen Ginsbury, PCI Pharmaceutical Consulting Ltd as she provides an outline of FDA's expectations for quality management, and addresses integration of risk management and ICH Q8, 9 and 10 into a modern, state-of-the-art Quality System that will comply with worldwide regulations because it is logical, systematic and regularly evaluated and overhauled. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: January 31, 2007 TOPIC: How to Conduct a Gap Analysis on your Quality Systems to comply with the FDA Guideline and future ICH Q10 requirements The FDA has recently created and approved the Quality Systems guideline to provide a consistent set of requirements that will compliment the current cGMP's and provide the tools for industry to implement effective Quality Systems that will guarantee the best product quality for the customers. The next step for most companies is to perform a "gap analysis" to determine what actions are necessary for them to be in compliance with the new guideline. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: January 25, 2007 TOPIC: A Comprehensive Approach to Microbial OOS Investigations in Purified Water Systems in Pharmaceuticals  In this web seminar, conducted by Sarma Donepudi, a recognized expert in Environmental Chemistry and Biology, participants will learn how to conduct an effective Out-of-Specification investigation with purified water systems and most importantly, how to PREVENT microbial contamination. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: January 16, 2007 TOPIC: Retirement Planning: Your GXP Computer System's IRA Barbara A. Nollau will focus on the requirements and good practices associated with retiring a regulated computer system. To ensure data integrity, protection of Intellectual Property, and ongoing quality assurance, it is essential for firms to retire computer systems and archive or migrate the respective data in a controlled and compliant way. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: January 11, 2007 TOPIC: Are You Doing The Right Thing? Choosing Your Chinese API/FDF Suppliers Wisely In this online seminar, our expert presenter Mr. Yushu Zhu will guide you through an overview of the landscape of the Chinese API export and import sector. Then, he will explain triggers of sourcing in China for Western pharmaceutical/generics companies in Part Two. Finally, Mr. Zhu will share his practical experience and provide a valuable review of the four major different types of API/FDF manufacturers in China. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: December 19, 2006 TOPIC: Cleaning Validation Recovery Study Rescues: Guidelines to Make Recovery Studies Simple Effective recovery studies ensure that we truly understand how much residue remains on the surface. They are a critical part of our understanding of our results from cleaning validation. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: December 12, 2006 TOPIC: Standardization Of Instrument Qualification, Re-Qualification And Calibration In Pharmaceutical Research And Development And Quality Control Laboratories This presentation will discuss many aspects of standardization of Metrology/Instrument management. Mr. Gaurav Walia, M.S., will focus on key examples of major instrument types (HPLC, Dissolution, Mass Spec, etc.) and standardized management philosophies in regards to instrument qualification, re-qualification and calibration. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: November 30, 2006 TOPIC: Web Seminar CD: Using FDA Warning Letter Trends to Create a Proactive Compliance Environment During this online, interactive web seminar our expert Michael Kuehne will show you how to analyze trends of FDA guidance documents to engender a proactive compliance environment within your organization. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: November 16, 2006 TOPIC: Mock FDA Inspection Mock FDA Inspection's is one of the most useful tools in preparing for a real FDA Inspection. The seminar will help you design a "mock inspection" for a particular facility and management team by focusing on specific needs. Presenter: Neil R. Armstrong ORDER EVENT CD (Flash Interactive CD)

Live event was held on: November 6, 2006 TOPIC: Packaging of Clinical Trial Supplies: Organization to Cope with Randomization Our expert presenter Karen Ginsbury will provide tips and share her experience regarding the unique aspects and risks associated with packaging of drug product and placebo for blinded clinical trials. Listen to audio preview. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: October 17, 2006 TOPIC: Cleaning Validation Limits: Limiting the Confusion Whether you have a single product facility, a multi-product facility, or a contract facility that is constantly changing the product mix in the plant, we all are faced with the need to establish practical, achievable, and verifiable limits. ORDER EVENT CD (Flash Interactive CD)

Live event was held on: September 26, 2006 TOPIC: Simplifying Vendor Qualification: Increasing Reliability and Reducing Testing Costs This interactive web seminar is ideal for those in purchasing, logistics, QA, QC, production, R&D, regulatory positions and for anyone dealing with the crucial area of vendor qualification! ORDER EVENT CD (Flash Interactive CD)

PLEASE NOTE: If you have any questions please contact us via info@ivthome.com