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Designing an Effective and Compliant Standard Operating Procedure (SOP) and Standard Test Method (STM)
Charity Ogunsanya
90 Min
Product Id: 705018
This webinar training will benefit manufacturers of manufactured products to achieve an effective, robust and compliant SOP and STM which will result in a cost effective and efficient manufacturing and testing of products. A well planned and written SOP or STM will reduce the incidence of out-of-specification (OOS) results, failure, product non-conformances, deviation and invalid assay investigations.
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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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Understanding the Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program
Charity Ogunsanya
90 Min
Product Id: 705008
This webinar will help the attendee gain an understanding of the requirements of current USP <85> Bacterial Endotoxin Test (BET), European Pharmacopoeia (Chapter 2.6.14) and the Japanese Pharmacopoeia (General Tests, No. 4.01). The webinar will provide the attendee the ability to understand the different LAL testing methodologies, choosing the best test method applicable to the product type, criticality of the BET test result as it applies to the release of a cGMP manufactured product.
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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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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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Validation Master Planning - The Unstated Requirements
John E Lincoln
90 Min
Product Id: 704292
This training program will focus on U.S. FDA and EU's MDD expect documented risk-based VMP planning, though the CGMPs mention little about it. The course will analyze product V&V versus process/ equipment V&V and how to use DQ, IQ, OQ, PQ, and ASTM E2500 equivalents.
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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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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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Overview of Life Cycle of an Analytical Method in Development and Manufacture of Biologics
Rajesh Gupta
60 Min
Product Id: 704755
This training program will offer an understanding of analytical method life cycle and regulatory expectations and requirements for the methods during product development. The webinar will also analyze risks and inherent variability of analytical methods.
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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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Understanding the Full Realm of Product Liability
Randall Goodden
60 Min
Product Id: 704743
This training program will highlight all the key areas that need to be under control or can lead to product recalls, product liability lawsuits, and the causes of these economic disasters for manufacturing corporations.
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ISO 9001:2015 Transition Overview
Kevin Gholston
90 Min
Product Id: 704781
The new ISO 9001:2015 requires companies to establish context of the organization and utilize this perspective along with the new High Level Structure (HLS) Clauses. This webinar is designed for quality assurance managers, management representatives, ISO 9001 implementation teams, and quality management system auditors. With the release of ISO 9001:2015 in September 23, 2015, now is the time to prepare. This 9001-2015 Transition Overview course will highlight the changes from the ISO 9001:2008 revision.
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4-Hr Virtual Training: Key Factors to Write an Effective Standard Operating Procedure and Work Instructions
Joy McElroy
4 hrs
Product Id: 704778
This training program will guide attendees in writing effective Standard Operating Procedures and Work Instructions. It will also discuss how to assess and write to the audience and how to review and revise SOPs and Work Instructions.
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Effective CDISC Clinical Data Acceptance Testing and Compliance
Sunil Gupta
75 Min
Product Id: 704687
This CDISC training program will enumerate clinical data issues, effective methods and SAS macros to identify data issues, and communicating and monitoring improvements in clinical data issues.