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Designing an Effective Cleaning and Disinfection Program for Pharmaceutical, Biotech, and Medical Device Cleanrooms
Jim Polarine
90 Min
Product Id: 700995
This webinar will provide valuable assistance to all FDA and EMEA regulated companies that need to validate their cleaning and disinfection programs.
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Differences in GMP Requirements between Drugs and Biologicals
Steven S Kuwahara
60 Min
Product Id: 700872
This presentation will cover the regulations that apply to biologics in general as well as those that apply to members of the special classes. This webinar will be directed at workers with some experience who must now deal with the manufacturing of various biological products.
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Implementing Process Controls for Optimum Performance of Cell-Based Assays
Dr. Wise Blackman
60 Min
Product Id: 700191
Guidance for developing, optimizing, validating and maintaining cells used for cell-based assays using control charts. Bioassays are defined as any biological assay that can be used to show that a product will perform its’ stated function. Due to the nature of bioassays they are inherently variable and require extra care to achieve consistent performance.
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Effective Method Transfer of Complex Bioassays
Ana Menendez
60 Min
Product Id: 700636
This Bioassays training/webinar will systematically outlines the steps needed to successfully transfer validated biological assays between GMP/GLP labs and also acquire non-validated assays for GMP/GLP development.
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Validation of Potency Bioassays for Biologicals
Ana Menendez
60 Min
Product Id: 700201
This Validation of Potency Bioassays training/webinar for Biologicals provides logical approaches that should be implemented during early development to increase predictability and deliver rugged, compliant assays through Phase III and commercialization.
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Cleanroom Design, Certification & Classification
Nazia Dar
60 Min
Product Id: 700404
This Pharmaceutical training will also provide attendees with the details and expectation stipulated in ISO 14644 series standards and FDA’s 2004 guidance document for aseptic processing. This seminar is designed to provide a thorough understanding of the principles applied to the design, qualification and operation of cleanrooms.
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CAPA Essentials - core principles and practices needed to implement an effective and efficient CAPA process
Susan C Reilly
60 Min
Product Id: 700299
This program is designed for the medical device, IVD, and combination product industries This webinar will provide the core principles and practices needed to implement an effective and efficient CAPA process
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Validation of Computerized Analytical Systems
Dr. Ludwig Huber
60 Min
Product Id: 700212
This Validation training will give a good understanding on what the requirements are and how to validate laboratory computer systems in the most cost-effective way.
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CGMPs for Investigational Drugs and Biologics
Barbara Immel
60 Min
Product Id: 700234
The European Union has stated their requirements in Annex 13, while FDA has recently issued a controversial new phase 1 guidance Join us for a discussion of actual requirements, and both historic and current guidance document recommendations
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Validation of Immunogenicity Assays for Biologicals
Ana Menendez
60 Min
Product Id: 700228
This Validation training describes logical approaches to efficiently develop assays that will deliver quality data. The main body of the talk reviews current industry guidelines with a goal to preparing a scientific validation protocol and method. The seminar also analyzes critical validation parameters, describes common technical pitfalls between various technologies and suggests solutions
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Change Control for Computer Systems - strategies and tools for FDA compliance
Dr. Ludwig Huber
60 Min
Product Id: 700078
This Computer system training will discuss strategies and provide tools for FDA compliance when managing change and version control of planned and unplanned changes.
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ISO 9001:2000 1st, 2nd and 3rd Party Auditing & Implementation
Mark Stevens
60 Min
Product Id: 700060
In this ISO 9001:2000 Training Understand the ISO 9001:2000 standard requirements for 1st, 2nd and 3rd part audits.
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Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies
Kenneth Christie
Product Id: 703635
This training program will provide attendees with a better understanding of how the FDA conducts their audits and the areas of most focus. In addition, it provides a summary of common GMP deficiencies given to drug manufacturers, to use to evaluate one’s own practices. Finally, when given a regulatory audit finding, this webinar will review the top five items to remember when submitting your responses to them to avoid further questions.
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Current Regulatory Requirements for Sterile Products
Kenneth Christie
Product Id: 703672
This webinar will highlight and summarize the main components relating to current validation requirements for sterile products and include the following; review of the current regulations and guidance documents, the typical expectations when aseptic processing is involved, the expectations for protocols used to document the qualification of associated equipment, utilities and processes, and recently cited regulatory deficiencies.
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The Regulatory Expectations for Environmental Monitoring Programs
Kenneth Christie
Product Id: 703648
Understand the importance of an effective environmental monitoring (EM) program and its place in your organization. This course will provide insights on regulatory requirements governing EM programs, contamination control practices, and common deficiencies cited by regulatory auditors when auditing EM programs.
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Challenges of an Effective Change Control Program
Kenneth Christie
Product Id: 704638
This training program will provide attendees with a better understanding of current Quality System Regulations (QSR) require companies to maintain qualified equipment, utilities and facilities in a state of control. When changes are made to these items, the change must be documented, explained as to what will be done and the items that may be impacted. This webinar will also highlight what is expected, what to include in procedures and address the challenges faced by industry in trying to establish an effective and manageable program.
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Particulates in Biological Products - Evolving Regulations for Testing in Clinical and Commercial Stages
Nanda Subbarao
Product Id: 701600
This webinar will discuss the evolving regulatory requirments for testing Biologics injectibles for sub-visible Particulates.
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Designing Effective and Efficient Extractables or Leachables Studies for Biologics
Nanda Subbarao
Product Id: 701591
Understand the steps of a extractables / leachables study, get knowledge about the gap analysis of literature sources and how to design an efficient E/L study.
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Basic Requirements for IQ, OQ and PQ Protocols
Kenneth Christie
Product Id: 704591
This training program will provide an outline of the typical protocols used for documentation of qualification activities, the type of information normally included in each and the common deficiencies cited when audited. It will highlight the importance of establishing specifications for all test challenges, proper documentation with regards to results obtained, how to address deviations encountered and how best to summarize results obtained.
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4-Hr Virtual Training: Ten Steps to Data Integrity in Pharmaceutical and Biotech Labs
Nanda Subbarao
Product Id: 704730
This training program will provide an introduction to regulatory expectations for data integrity, discuss generation, review and archiving of data, enumerate evolving requirements for eData, and expound on support systems for data integrity.