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Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?
Henry Urbach
90 Min
Product Id: 703058
This webinar on biopharmaceutical raw material testing will discuss how to implement processes for the control of microbial contamination, establish microbial limits and mitigate the risk of contamination.
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Equipment Qualification Basics
Joy McElroy
90 Min
Product Id: 704403
This training program will list the documents required for equipment qualification and process validation and discuss how to manage documents appropriately. Attendees will gain insight into best practices for writing and maintaining a Validation Master Plan (VMP). The course will also discuss best practices for writing and executing sound protocols for equipment qualification (IQ, OQ, PQ) and process validation.
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You Found an Objectionable Microorganism, Now What? Risk of presence of Objectionable Microorganisms in Biopharmaceuticals
Henry Urbach
60 Min
Product Id: 702964
This webinar on objectionable microorganisms will explore the most current practices that define an objectionable microorganism and will provide a practical approach to determining just how objectionable it really is.
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Selection and Management of Contract Vendors
Peggy Berry
90 Min
Product Id: 704884
This webinar will discuss approaches to selecting vendors to perform manufacturing and testing activities as well as clinical study activities. The information obtained will enable implementation of an effective vendor selection program and a comprehensive vendor management and oversight program. The webinar will address aspects of requesting bids, performing audits, evaluating risks, and preparing plans and agreements for effective oversight and management.
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Integrating Pharmacovigilance and Technical Complaint Systems
David L Chesney
90 Min
Product Id: 704956
This webinar will discuss the FDA requirements for pharmacovigilance and complaint evaluation under GMP
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Critical Elements of Quality Risk Management Relating to FDA Compliance
Danielle DeLucy
60 Min
Product Id: 704829
This training program will discuss risk management and outline the requirements for applying risk management to the quality system. It will also discuss how to conduct and implement risk management practices at your firm and review communication techniques to highlight the benefits of risk management.
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Providing DMFs in eCTD format
Peggy Berry
90 Min
Product Id: 704934
This webinar will review the CTD format and content requirements for the DMF. It will discuss the transition from other formats to the CTD/eCTD and technical requirements for eCTD submission.
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Creating Effective SOPs for Regulatory Compliance
Henry Urbach
60 Min
Product Id: 702999
This FDA documentation webinar will explain the regulatory expectations for, and the proper design and maintenance of effective and compliant standard operating procedures (SOPs).
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4-hr Virtual Seminar: The Quality Manual Ensuring Regulatory Requirements
Howard Cooper
4 hrs
Product Id: 704915
This 4-hr webinar will focus on product lifecycle concepts that are applicable to all of the FDA regulated industries. Learn the objectives, purpose and scope of the quality manual and how to can be adapted to each different business environment.
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The FDA Compliance Enforcement Process
David L Chesney
90 Min
Product Id: 704913
This 90 mins webinar will provide a thorough understanding of the range of FDA enforcement options and the criteria the agency applies in deciding which to use.
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Veterinary Medicine and the DEA Due Diligence Requirement for Dispensing and Prescribing a Controlled Substance
Carlos M Aquino
60 Min
Product Id: 704892
This webinar will discuss federal laws and regulations covering all veterinarians who dispense and prescribe controlled substances, record-keeping requirements, penalties for non-compliance and the DEA due diligence required.
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Type 2 DMFs for Active Pharmaceutical Ingredients (APIs)
Peggy Berry
90 Min
Product Id: 704882
This webinar will discuss approaches to developing and understanding the manufacturing process for a drug substance. The information obtained will enable completion of the drug substance information in the Drug Master File – in support of Module 3 of a CTD application. The webinar will address aspects of development and manufacture of the drug substance including steps to reduce impurities. Both traditional and enhanced approaches are discussed.
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Biological Indicators for Sterilization Performance Qualification
Aaron Mertens
90 Min
Product Id: 704879
This webinar will focus on biological indicator usage for sterilization performance qualification in the pharmaceutical and biotech industry. Biological indicator preparation, including population and D-value resistance determination, is presented in depth. Understanding these details is critical to successfully choose a biological indicator and qualify a sterilization process.
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Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing
Henry Urbach
60 Min
Product Id: 702634
This 60-minute webinar will show how you can design a robust microbiological audit program for pharmaceutical and biopharmaceutical product manufacturing, that effectively assesses your facility and that of your supplier to ensure your facilities and products are free from microbial contamination.
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Steam Sterilization Microbiology and Autoclave Performance Qualification
Aaron Mertens
90 Min
Product Id: 704850
This webinar will discuss the regulatory and GMP requirements for steam sterilization and the mechanism as it relates to bacterial cells and endospores. The training will cover autoclave performance qualification studies and the tools to be used.
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Extractables and Leachables - Biopharma Polymeric Devices
Mark Trotter
90 Min
Product Id: 704798
This webinar training will examine the key topics concerning the use of polymeric single-use products in biopharm processes. It will offer a basic understanding of industry standards and regulatory compliance. The training program is designed for the experienced as well as those new to biopharmaceutical processes and need to know current requirements for determination of extractables and leachables in biopharm processes.
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Managing SOP Compliance per FDA Regulations
Danielle DeLucy
60 Min
Product Id: 704797
This training program will discuss formatting SOPs, FDA expectations for written documents and regulatory requirements, and the roles and responsibilities of authors and reviewers of SOPs. The program will also overview how to ensure a system for the control, archival, and disposal of written procedures.
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Renovation of Aging Aseptic and Biological Facilities
Erich Bozenhardt
60 Min
Product Id: 704789
In this training program, attendees will explore modern technologies, process changes and smart architectural design that can extend the useful life of manufacturers' aseptic and biologic facilities by 10 to 20 years. These upgrades can also make facilities more compliant, cut down on operating risks, and improve performance.
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Preparation for GMP Inspections by Regulatory Agencies
Peggy Berry
90 Min
Product Id: 704843
This GMP inspections webinar will review what to expect during the agency inspection and how to successfully and efficiently streamline and manage the inspection, including adequate follow-up during and after the inspection.
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Comparing the Pharmaceutical and Medical Device Product Lifecycles
Howard Cooper
120 Min
Product Id: 704853
This webinar will help you gain a greater understanding of regulatory and compliance requirements and how the early product lifecycle requirements establish the basic groundwork as a foundation from product development to commercialization continuing to out commercialization and product discontinuation.