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Cleaning Validation And Critical Cleaning Processes
July 14-17, 2008
Renaissance Chicago Hotel, Chicago, IL
One of IVT’s most popular conferences, it defines a comprehensive approach
to the validation of cleaning procedures for pharmaceutical and biopharmaceutical
manufacturing facilities.
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WEB SEMINAR CD Series: Advanced Topics in LC Method Validation
This 6 CD Series collection is presented by Dr. Michael Swartz will explore 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.
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WEB SEMINAR CD Series: Validation Basics A-Z: Planning, Implementing & Maintaining
This is a 5 CD collection with our expert presenter Dr. Gamal Amer
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Pharmaceutical Technology's Third Annual QPEC Conference
July 21-23, 2008
The Westin Arlington Gateway, Arlington, VA
Pharmaceutical Technology Magazine, the leader in cutting-edge information
for the pharmaceutical industry, presents a case study-driven conference and exhibition.
This dynamic event will bring together global industry leaders and regulatory
representatives who will present their experiences and showcase their products
in three tracks: Global Quality Initiatives, FDA Inspections, Lean Design
and Deployment.
Early Bird Special! Register by June 2, 2008
View event website: www.pharmtechevent.com
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WEB SEMINAR CD: 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. At this presentation attendees will learn. . .
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GXP Training
June 17-19, 2008
Catamaran Resort, San Diego, CA
Effective Design, Implementation, and Maintenance of Training Programs with Emphasis on New FDA and International Regulatory Trends. After completing this course, you will gain an improved understanding of practical training
methods that will yield optimal employee performance and regulatory compliance
within your organization.
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The Cleaning Validation Toolkit
8 titles included: The discipline of Cleaning Validation is as individual as process validation, but the methods, techniques and risks are almost identical in all kinds of pharmaceutical manufacture.
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Aseptic Processing of Sterile Drug Products
June 17-19, 2008
Catamaran Resort, San Diego, CA
This conference will offer an in-depth look at many facets of aseptic processing and microbiology. Attendees will gain invaluable knowledge in techniques of the most current interest, the associated regulatory requirements in general, and quality control and validation. Attendees will receive actionable tools for aseptic
and sterile processes from an ALL case study format. Learn directly from major pharmaceutical company's who deal directly with these processes and see live cutting edge technology demonstrations.
View event website: www.asepticevent.com
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Change Control Combo SPECIAL OFFER
SPECIAL EDITION - Change Control Implementation AND A Practical Guide to Change Control System Managememt
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Computer System Validation in FDA-Regulated Industries
April 29-May 2, 2008
Baltimore's Tremont Suites Hotel, Baltimore, MD
The overall focus of the program is computer validation as it applies to drugs, devices and clinical and as it spans from R & D to manufacturing. The goal is to facilitate a sharing of knowledge on common interest across these areas.
View event website: www.computervalidationevent.com
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Laboratory Compliance
April 29 - May 2, 2008
Baltimore's Tremont Suites Hotel Baltimore, MD
Best Practices to Build, Implement and Optimize Process Excellence
A spectacular forum for education and open discussion on the three hottest issues
in analytical laboratories: compliance, method validation and stability testing.
View event website: www.labweekevent.com
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Pharmaceutical Statistics 2008
March 18 & 19, 2008
The Westin Arlington Gateway - Arlington, Virginia - Pharm Stats 2008: Confronting Controversy
is designed as a different kind of statistics conference. Leaving tradition
and brain-drain at the door.
View event website www.pharmstats2008.com
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event brochure
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Web Seminar CD: Risk Based Approach to cGMP Systems
This presentation will 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.
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Web Seminar CD: Deviations in 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.
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Web Seminar CD: 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.
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Web Seminar CD: 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.
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Web Seminar CD: 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.
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Web Seminar CD: 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.
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Web Seminar CD: 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.
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Web Seminar CD: Pay Now or Pay (More!)Later: Optimizing the Computer Systems Maintenance Phase
This event will focus 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.
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Web Seminar CD: The New Process Validation FDA Perspective - Basis for the Revision to the 1987 FDA PV Guideline
How to determine if your Design process and documentation is adequate for the new FDA perspective. . .
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Web Seminar CD: Proper Documentation and SOPs to Ensure Compliance in the Lab
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Web Seminar CD: 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.
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Web Seminar CD: CAPA: A Risk Mitigating Quality System
We will first define what we mean by risk. We will then explore the factors associated with risk in compliance. We will also explore risk causing events and how to address them. A review of risk severity/level will then ensue. Upon completion of risk part of the presentation we will define what a CAPA system would look like.
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Handbook to Laboratory Best Practices, Training and Facing Challenges
There are some who still believe (or still want to believe) that there are no regulations that apply to “Research”. This simply is not true.
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Handbook to GMP Training, Compliance & Risk Management Solutions: A European Perspective
This handbook highlights the need for patient focused & value adding qualification, validation & change control programmes for manufacturing and regulatory which are cost effective & in line with current regulatory requirements.
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Web Seminar CD: 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.
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Web Seminar CD: Developing and Validating LC Stability Indicating Assays
This presentation will outline how forced degradation is used to develop a SIM, and examines some of the method development and validation parameters critical to its success.
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Web Seminar CD: Proper Design and Maintenance of GMP Training Program with Emphasis on New FDA and Industry Trends
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Web Seminar CD: 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.
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Web Seminar CD: 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.
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Web Seminar CD: Quality Systems and Risk Management:
A Multi-national Approach
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.
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Web Seminar CD: How to Conduct a Gap Analysis on your Quality Systems to comply with the FDA Guideline and future ICH Q10 requirements
The drug manufacturing industry has been implementing Quality Systems concepts for many years without a specific guideline or list of requirements but just referencing the QSR for devices and several FDA policies and iniciatives.
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Web Seminar CD: 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.
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Web Seminar CD: Retirement Planning: Your GXP Computer System's IRA
This interactive web seminar 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.
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FDA Main Toolkit
This Toolkit includes: Special Edition: cGMP Training, Special Edition: cGMP Training II, A Pocket Guide to cGMP Sampling, Web Seminar CD: Mock FDA Inspection and Web Seminar CD: Using FDA Warning Letter Trends to Create a Proactive Compliance Environment
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FDA CD Toolkit
This Toolkit includes: Two Web Seminar CDs -- Mock FDA Inspection and Using FDA Warning Letter Trends to Create a Proactive Compliance Environment
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FDA Print Toolkit
This Toolkit includes: Special Edition: cGMP Training, Special Edition: cGMP Training II and A Pocket Guide to cGMP Sampling
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Web Seminar CD: 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.
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Medical Device Design Control Program
The Medical Device Design Control Program is a suite of documents that collectively establishes a comprehensive Product Development Program (PDP). The Suite consists of a set of twenty-five (25) inter-related standard operating procedures, templates and forms ready for customization.
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Web Seminar CD: Using FDA Warning Letter Trends to Create a Proactive Compliance Environment
Our expert Michael Kuehne will show you how to analyze trends of FDA guidance documents to engender a proactive compliance environment within your organization.
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Web Seminar CD: Mock FDA Inspection
We will cover the conduct of a “mock inspection”, from both the “mock inspector’s” and the management’s standpoint, and some commonly used inspection techniques. We will then continue to look at the elements of real inspection and how these can be adapted to and covered in a “mock inspection”.
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SOP Library
The SOP Library provides you with SOP templates in both GCP and GMP documents. From FDA Inspections of Clinical Sites to Quality Control.
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Biological Industry Pocket Guide
Biological products are complex entities and that is why IVT has compiled this handy pocket guide
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Pharmaceutical Industry GMP’s 21 CFR Parts 210 & 211
A useful, portable and spiral bound pocket guide that contains 21 CFR Parts 210 & 211.
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Process Validation Combo
The Special Edition: Conducting Audits, Corrective and Preventive Action and Process Validation
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IVT Operations Combo
The IVT Operations Combo will assist you and your company with Facility, Utility and Equipment & Instrumentation Qualification.
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Cleaning Validation Handbook
The discipline of Cleaning Validation is as individual as process validation, but the methods, techniques and risks are almost identical in all kinds of pharmaceutical manufacture.
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