WEBINARS

 

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

Objectionable Microorganisms in Biopharmaceutical Manufacturing

webinar-speaker   Carl Patterson

webinar-time   60 Min

Product Id: 705319

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.

Recording Available

* Per Attendee $249

 

Automating Assays for Clinical Diagnostics

webinar-speaker   Todd Graham

webinar-time   60 Min

Product Id: 703268

This webinar on automating laboratory assays will teach you how to translate an assay that is performed manually to one that is fully automated, with high quality and with proper validation and quality assurance for regulatory purposes.

Recording Available

 

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

webinar-speaker   Gwen Wise Blackman

webinar-time   180 Min

Product Id: 705019

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.

Recording Available

* Per Attendee $349

 

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

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 704848

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.

Recording Available

* Per Attendee $249

 

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

webinar-speaker   John R Godshalk

webinar-time   60 Min

Product Id: 704806

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

Recording Available

* Per Attendee $249

 

Pharmaceutical and Biologics Facility Design: FDA and Regulatory Aspects

webinar-speaker   John R Godshalk

webinar-time   60 Min

Product Id: 704841

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.

Recording Available

* Per Attendee $349

 

Creating FDA-compliant Microbial Contamination Control Program for Biopharmaceutical Manufacturing

webinar-speaker   Henry Urbach

webinar-time   90 Min

Product Id: 703474

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.

Recording Available

* Per Attendee $249

 

Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production

webinar-speaker   Henry Urbach

webinar-time   90 Min

Product Id: 705072

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.

Recording Available

* Per Attendee $249

 

Understanding and Remediating Corrosion Problems during Parenterals Manufacturing

webinar-speaker   Barrett Rabinow

webinar-time   2 hrs

Product Id: 704983

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.

Recording Available

 

Providing DMFs in eCTD format

webinar-speaker   Peggy Berry

webinar-time   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.

Recording Available

 

Biological Indicators for Sterilization Performance Qualification

webinar-speaker   Aaron Mertens

webinar-time   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.

Recording Available

 

Steam Sterilization Microbiology and Autoclave Performance Qualification

webinar-speaker   Aaron Mertens

webinar-time   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.

Recording Available

 

Managing SOP Compliance per FDA Regulations

webinar-speaker   Danielle DeLucy

webinar-time   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.

Recording Available

 

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

webinar-speaker   Rajesh Gupta

webinar-time   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.

Recording Available

 

Renovation of Aging Aseptic and Biological Facilities

webinar-speaker   Erich Bozenhardt

webinar-time   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.

Recording Available

 

Successful Deviation Investigations

webinar-speaker   Danielle DeLucy

webinar-time   60 Min

Product Id: 704596

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.

Recording Available

 

Biological Facility Design: Design for Compliance

webinar-speaker   Erich Bozenhardt

webinar-time   60 Min

Product Id: 704576

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.

Recording Available

* Per Attendee $229

 

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

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 704587

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.

Recording Available

* Per Attendee $229

 

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

webinar-speaker   Michael Simonian

webinar-time   90 Min

Product Id: 704185

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.

Recording Available

* Per Attendee $249

 

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

webinar-speaker   Robert J Russell

webinar-time   3 hrs

Product Id: 704356

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.

Recording Available

* Per Attendee $429

 

 

 

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