ComplianceOnline

Biologics and Biosimilars Regulatory Compliance Training - Live Webinars, Recordings & CDs

Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training
19
/ Dec
Wednesday-2018

Processes & Effects of Immunogenicity to Biologics & the Screening Methodologies - 3 hour Virtual Training

  • Speaker: Gwen Wise Blackman
  • Product ID: 705019
  • Duration: 180 Min
This 3 hour virtual training will provide an overview of the concepts and types of immune responses elicited by biologics. The factors contributing to immunogenicity and impact on efficacy and safety will be identified. Validated screening and confirmatory methods that measure an immune response to a biologic during the various stages of development, clinical studies and post-approval surveillance will be discussed.
* Per Attendee
$299
Recorded/CD
Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

Drafting a Software Verification and Validation Report Package and Protocol - The 11 Must-have Documents

  • Speaker: John E Lincoln
  • Product ID: 704848
  • Duration: 90 Min
A tougher U.S. FDA expects a company to maintain certain documents in equipment, process and product software V&V. These documentation requirements can assist in a 21 CFR Part 11 CGMP records / signature V&V as well. This training program will provide valuable assistance to all regulated companies in evaluating their existing or anticipated software V&V activities and documentation requirements, especially in light of the changes in the FDA's stance vis a vis industry compliance, past problems, and the growing cloud environment. It will help attendees understand and recognize the most common software V&V failings and their fixes. The webinar will allow attendees to develop and use a repeatable software V&V template for all software validation projects.
CD/Recorded
$249
Recorded/CD
Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience

Good Practices for Data Integrity, the new Guidance and one FDA Inspector's Experience

  • Speaker: John R Godshalk
  • Product ID: 704806
  • Duration: 60 Min
This webinar, by an ex-FDA, will cover Good Data Integrity Practice for GxP environments. Participants will understand what FDA looks for with regard to data integrity, what may need to be audited, the new guidance and application of data integrity, and relevant regulations for data integrity
CD/Recorded
$249
Recorded/CD
Objectionable Microorganisms in Biopharmaceutical Manufacturing

Objectionable Microorganisms in Biopharmaceutical Manufacturing

  • Speaker: Carl Patterson
  • Product ID: 705319
  • Duration: 60 Min
This webinar will discuss the regulations pertaining to objectionable microorganisms, agency expectations, methods to identify objectionable microorganisms, interpreting results, and controls to put into place.
CD/Recorded
$249
Recorded/CD
Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects

Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects

  • Speaker: John R Godshalk
  • Product ID: 704841
  • Duration: 60 Min
This webinar will cover what is important in facility design from the FDA and regulatory standpoint. You will understand what FDA looks for during a facility inspection. You will be able to minimize possible design errors which are difficult and expensive to fix post-build. Understand what FDA looks for in reviewing the facility design and the flow patterns.
CD/Recorded
$349
Recorded/CD
Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing

Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing

  • Speaker: Henry Urbach
  • Product ID: 703474
  • Duration: 90 Min
This webinar will enable participants to understand sources of contamination and to investigate various contamination issues in the biopharmaceutical manufacturing of sterile and non-sterile products. Learn how to create an effective Environmental Monitoring (EM) program.
CD/Recorded
$249
Recorded/CD
Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

  • Speaker: Henry Urbach
  • Product ID: 705072
  • Duration: 90 Min
This webinar you will discuss how to help your organization get a better handle on what is an “objectionable microorganism, ” exactly how “objectionable” it really is and what you can do to minimize the risk if you find one in your process or product.
CD/Recorded
$249
Recorded/CD
Understanding and Remediating Corrosion Problems during Parenterals Manufacturing

Understanding and Remediating Corrosion Problems during Parenterals Manufacturing

  • Speaker: Barrett Rabinow
  • Product ID: 704983
  • Duration: 2 hrs
In this two-hour webinar you will learn how to recognize problems related to corrosion, how to diagnose their specific causes, and how to remediate them. This webinar surveys the range of corrosion-mediated failure modes of parenteral solution manufacture. The roles of physical factors such as temperature, humidity, oxygen as well as formulation variables such as chloride level, pH, and inorganic metals will be discussed in this session.
Recorded/CD
Providing DMFs in eCTD format

Providing DMFs in eCTD format

  • Speaker: Peggy Berry
  • Product ID: 704934
  • Duration: 90 Min
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.
Recorded/CD
Biological Indicators for Sterilization Performance Qualification

Biological Indicators for Sterilization Performance Qualification

  • Speaker: Aaron Mertens
  • Product ID: 704879
  • Duration: 90 Min
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.
Recorded/CD
Steam Sterilization Microbiology and Autoclave Performance Qualification

Steam Sterilization Microbiology and Autoclave Performance Qualification

  • Speaker: Aaron Mertens
  • Product ID: 704850
  • Duration: 90 Min
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.
Recorded/CD
Managing SOP Compliance per FDA Regulations

Managing SOP Compliance per FDA Regulations

  • Speaker: Danielle DeLucy
  • Product ID: 704797
  • Duration: 60 Min
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.
Recorded/CD
Overview of Life Cycle of an Analytical Method in Development and Manufacture of Biologics

Overview of Life Cycle of an Analytical Method in Development and Manufacture of Biologics

  • Speaker: Rajesh Gupta
  • Product ID: 704755
  • Duration: 60 Min
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.
Recorded/CD
Renovation of Aging Aseptic and Biological Facilities

Renovation of Aging Aseptic and Biological Facilities

  • Speaker: Erich Bozenhardt
  • Product ID: 704789
  • Duration: 60 Min
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.
Recorded/CD
Successful Deviation Investigations

Successful Deviation Investigations

  • Speaker: Danielle DeLucy
  • Product ID: 704596
  • Duration: 60 Min
This training program will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. This webinar will focus on how to avoid the pitfalls that may occur during FDA inspections and help eliminate 483 observations. Attendees will learn how to identify and avoid potential pitfalls during deviation investigations.
Recorded/CD
Biological Facility Design: Design for Compliance

Biological Facility Design: Design for Compliance

  • Speaker: Erich Bozenhardt
  • Product ID: 704576
  • Duration: 60 Min
This training program will explore the ABCs of facilities enhancement – compliance-driven actions that get results. It will also discuss devising and implementing a bullet-proof plan to reach goals, set expectations, and lower costs.
CD/Recorded
$229
Recorded/CD
US, EU, Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus

US, EU, Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus

  • Speaker: Robert J Russell
  • Product ID: 704587
  • Duration: 90 Min
This 90-minute webinar will help you gain a comprehensive understanding of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will prepare you for regulatory inspections in these countries.
CD/Recorded
$229
Recorded/CD
Methods for Detecting Mycoplasma Contamination in the Manufacture of Pharmaceuticals and Biologics

Methods for Detecting Mycoplasma Contamination in the Manufacture of Pharmaceuticals and Biologics

  • Speaker: Michael Simonian
  • Product ID: 704185
  • Duration: 90 Min
This training program will help attendees understand the sources of mycoplasma contamination and how to minimize the occurrence of contamination. The regulatory standards for testing will be described as well as the methods of mycoplasma detection and the resources for testing. At the conclusion of this webinar, attendees will have knowledge of the importance of mycoplasma contamination testing and how to successfully perform the tests in their company’s setting.
CD/Recorded
$249
Recorded/CD
3-Hour Virtual Training: Russia Regulatory Compliance Requirements for Life Science Products

3-Hour Virtual Training: Russia Regulatory Compliance Requirements for Life Science Products

  • Speaker: Robert J Russell
  • Product ID: 704356
  • Duration: 3 hrs
This training course will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of life science products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. It will offer a deeper understanding of cultural norms, and will discuss best practices for establishing relationships and protecting your intellectual property to be integrated into your company’s training and corporate business strategies.
CD/Recorded
$429
Recorded/CD
FDA’s New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices

FDA’s New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices

  • Speaker: Angela Dunston
  • Product ID: 704431
  • Duration: 90 Min
This training program will provide a review of the current testing requirements and discuss what happened to the old 87/91 LAL Guidance for Industry proposed guidance. The program will also discuss how to transition from one bacterial endotoxin test to another—understanding the RPT (Rabbit Pyrogen Test). Participants will also gain a clearer perspective of the Monocyte Activation Test (MAT).
CD/Recorded
$229
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