Strategies to Conduct a Successful Method Transfer according to FDA Expectations

webinar-speaker   Kim Huynh-Ba

webinar-time   90 Min

Product Id: 705059

This webinar discusses how to execute meaningful Method Transfers by selecting appropriate analytical performance characteristics and acceptance criteria, documentation of the transfer process and how to avoid failures.

Recording Available

 

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

 

Basic Concepts of Sterility Assurance

webinar-speaker   Mark Seybold

webinar-time   90 Min

Product Id: 705046

This course will provide a foundation for developing your technical skills related to sterility assurance.

Recording Available

 

Designing an Effective and Compliant Standard Operating Procedure (SOP) and Standard Test Method (STM)

webinar-speaker   Charity Ogunsanya

webinar-time   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.

Recording Available

 

Prospects for Change at FDA Under the Trump Administration: Early View of What 2017 Will Bring

webinar-speaker   Steven Grossman

webinar-time   90 Min

Product Id: 705023

This webinar will discuss FDA's current priorities and the agency's likely priorities and the future of regulations and policies in 2017 under the new Trump administration.

Recording Available

* Per Attendee $199

 

Why I should test raw materials for microbial presence and what is the microbiological and business risk if I choose not to?

webinar-speaker   Henry Urbach

webinar-time   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.

Recording Available

* Per Attendee $199

 

Effective Deviation Investigators Under GMP

webinar-speaker   David L Chesney

webinar-time   120 Min

Product Id: 704974

This 120 minute training course 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. Learn how to identify and avoid potential pitfalls during deviation investigations.

Recording Available

* Per Attendee $299

 

Understanding the Basic Requirement of the Bacterial Endotoxin Testing (BET) or LAL Program

webinar-speaker   Charity Ogunsanya

webinar-time   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.

Recording Available

 

Russia: Compliance Processes and Regulations

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 703870

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 $249

 

You Found an Objectionable Microorganism, Now What? Risk of presence of Objectionable Microorganisms in Biopharmaceuticals

webinar-speaker   Henry Urbach

webinar-time   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.

Recording Available

* Per Attendee $229

 

Validation Master Planning - The Unstated Requirements

webinar-speaker   John E Lincoln

webinar-time   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.

Recording Available

* Per Attendee $279

 

Creating Effective SOPs for Regulatory Compliance

webinar-speaker   Henry Urbach

webinar-time   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).

Recording Available

* Per Attendee $199

 

USP Hot Topics: What's Hot Now and How to Track Coming Changes and Influence USP

webinar-speaker   Gregory Martin

webinar-time   90 Min

Product Id: 703521

This webinar will provide insight into some of the hottest topics at USP which will have the greatest impact on pharmaceutical laboratories. It will provide a comprehensive overview of the major changes in the USP that have been proposed or implemented in the last year and describe strategies for keeping abreast of coming changes and how you can influence them.

Recording Available

* Per Attendee $249

 

Auditing for Microbiological Aspects of Pharmaceutical and Biopharmaceutical Manufacturing

webinar-speaker   Henry Urbach

webinar-time   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.

Recording Available

* Per Attendee $229

 

FDA Compliance and Laboratory Computer System Validation

webinar-speaker   Carolyn Troiano

webinar-time   60 Min

Product Id: 704660

Upon completion of this training program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, based on the System Development Life Cycle (SDLC) framework. They will have received the guidance on industry best practices necessary to develop a compliant and cost-effective validation program. They will understand the steps for validating laboratory systems, along with the key documentation associated with maintaining the systems in a validated state, while minimizing costs. Attendees will gain a good grasp of how to leverage these practices across all systems by creating a standardized program.

Recording Available

 

Quality Writing for Technical Communicators

webinar-speaker   Phil Vassallo

webinar-time   60 Min

Product Id: 704017

This training program will address the daunting task of conveying complex technical data clearly, concisely, and purposefully to technical and non-expert audiences alike. Writing examples from diverse technical fields makes this webinar highly relevant. The program will build a foundation for learning by identifying the qualities of effective writing and the roadblocks to overcoming them.

Recording Available

* Per Attendee $199

 

FDA Vs Health Canada

webinar-speaker   Angela Dunston

webinar-time   60 Min

Product Id: 703970

This training program will elucidate the similarities and differences between the FDA and Health Canada promulgations of regulations impact preparation. The course will also offer a review of the background and history behind the FDA and Health Canada.

Recording Available

* Per Attendee $249

 

Creating FDA-compliant cGMP Training Program

webinar-speaker   Henry Urbach

webinar-time   60 Min

Product Id: 703401

This webinar will explain how to implement an effective and FDA compliant GMP training program. It will discuss regulatory requirements and expectations for a well-trained workforce.

Recording Available

* Per Attendee $179

 

Integration of ERP and Legacy FDA-Regulated Systems

webinar-speaker   Carolyn Troiano

webinar-time   60 Min

Product Id: 704547

This training program will assist those responsible for planning, executing or managing the integration of a business system with any laboratory system governed by FDA regulations. On completing the program, attendees will have an understanding of laboratory system computer validation planning, execution and management concepts, and how they apply to any integrated business system.

Recording Available

 

Worksheets that Capture SOP Details and Are Compliant

webinar-speaker   Edward O Connor

webinar-time   60 Min

Product Id: 704532

This training program will focus on understanding the drivers and benefit of using worksheets not only as a prompt for recording details but also in reducing efforts of the analysts and auditors in a GLP/GCP bioanalytical lab.

Recording Available

 

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