WEBINARS

 

FDA Regulatory Compliance Training - Live Webinars, Recordings & CDs

Grant Writing - All You Need to Know About Criteria, Parameters, Obligations, Application Structure and Grant Reporting

webinar-speaker   Vidia Ramdeen

webinar-time   60 Min

Product Id: 704550

This training program will help participants identify grant opportunities and get started with the grant writing process. They will gain insight into public/private grants, the grant application process and grant reporting.

Recording Available

 

Protecting Your Intellectual Property Abroad

webinar-speaker   Douglas Cohen

webinar-time   60 Min

Product Id: 702972

IP piracy costs more than a loss in sales. If your brand loses value because it is seen as less exclusive or is confused with poor imitations this poses a long term threat to profitability. Re-establishing brand identity and company reputation is expensive if not impossible. This webinar will provide specific, practical steps to take to lessen this risk of loss.

Recording Available

 

CDISC Cloud Computing in the Pharmaceutical Industry: Paradigm Shift in Project Management, Analysis and Validation

webinar-speaker   Sunil Gupta

webinar-time   75 Min

Product Id: 704674

This training program will help you better manage projects and offer practical tools to understand data content and quality. Attendees will learn to apply validation methods to reduce time to validate clinical summary tables. Attendees will also learn to apply advanced SAS programming techniques to standardize and automate the validation process.

Recording Available

 

Pharmaceutical Company Specific Records and Information Management Programs

webinar-speaker   Charlie Sodano

webinar-time   60 Min

Product Id: 704667

This training program will focus on creating a workable and effective records and information policy. It will also discuss establishing records and information management responsibilities, determining the locations of all information resources, planning long term archiving, and content and records management software considerations and options.

Recording Available

 

Renovating Existing Manufacturing Space to Accommodate Aseptic Fill/Finish

webinar-speaker   Erich Bozenhardt

webinar-time   60 Min

Product Id: 704665

This training program will give you the foundational tools necessary to identify changes that need to be made while renovating existing manufacturing space, formulate a concise implementation plan that includes compliance protocols, and allows for continuous improvement.

Recording Available

 

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

 

Standards and Their Role in Medical Device and Patient Safety

webinar-speaker   Lena Cordie Bancroft

webinar-time   90 Min

Product Id: 704654

This training program will explore the relationship of standards to medical device legal requirements. It will clarify the standards development process and discuss relationship of standards to patient safety.

Recording Available

 

Preventing Recalls and Product Liability Lawsuits - Current Trends and Causes

webinar-speaker   Randall Goodden

webinar-time   60 Min

Product Id: 703080

This webinar will highlight the current statistics and trends regarding product recalls, product liability lawsuits, and the causes of these economic disasters for manufacturing corporations. It will also identify all the areas of manufacturing management that are typically not being handled properly and contribute to such failures, from product development thru marketing, product testing, supplier selection and control, document management, contracts and agreements, manufacturing quality, and incident investigation.

Recording Available

* Per Attendee $229

 

Combination Products - The FDA's New Codifications of the cGMP Requirements Applicable to Combination Products

webinar-speaker   Angela Dunston

webinar-time   120 Min

Product Id: 704623

This training program will analyze the general considerations for cGMP compliance and review the cGMP requirements in 21 CFR 4.4(b). The program will also discuss applications of cGMP requirements for specific types of combination products.

Recording Available

 

Ensure Compliance to FDA's Design Control Requirements by using Requirements Management Techniques

webinar-speaker   Mercedes Massana

webinar-time   60 Min

Product Id: 701557

This webinar on FDA's design control requirements will discuss how a requirements management approach consistent with the CMMi Requirements Management KPA, helps companies meet FDA's Design Control requirements.

Recording Available

* Per Attendee $249

 

Single-Use Systems and Technologies

webinar-speaker   Mark Trotter

webinar-time   90 Min

Product Id: 704609

This training program will examine the many facets of disposable bioprocessing systems that incorporate a wide scope of polymeric single-use products. Single-use disposable technologies, from upstream to downstream processes, will be reviewed as related to the use of polymeric devices. Specific attention will be given to the related applications used in the production of biopharmaceuticals and pharmaceuticals.

Recording Available

 

Technology Transfer and Validation for Medical Devices and Pharmaceuticals: The Link between Development, Validation and Commercial Production

webinar-speaker   Carlos Rodriguez Garcia

webinar-time   60 Min

Product Id: 704248

The parallel requirements for medical devices and pharmaceuticals are incorporated into this comprehensive webinar that delineates the foundation for technology transfer and validation, encompassing regulatory requirements and voluntary guidance.

Recording Available

* Per Attendee $279

 

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

 

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

 

Best Practices in Being ‘On Call’ for FDA Submission Audits in the CDISC Programming Environment

webinar-speaker   Sunil Gupta

webinar-time   75 Min

Product Id: 704594

This training program will assist anyone directly or indirectly responsible for the creation, content or validation of SDTMs, ADaMs, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. It will help attendees in determining how well your company is positioned to defend your FDA submission.

Recording Available

 

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

 

Hazardous Substance Management for Medical Devices and In-Vitro Diagnostics - Comprehensive Regulatory Support for the Supply Chain

webinar-speaker   Wilhelm Pfleger

webinar-time   60 Min

Product Id: 704228

This training program will offer an interpretation of the latest ruling of Reach SVHC. It will also discuss the RoHS directive – the four substances added to the restriction list in Annex II.

Recording Available

* Per Attendee $179

 

Preparing for a UDI Implementation

webinar-speaker   Lena Cordie Bancroft

webinar-time   90 Min

Product Id: 704579

This training program will help attendees understand the requirements of the FDA UDI regulation and the labeling requirements of the UDI regulation. The program will also focus on data elements that make up a UDI compliant barcode and GUDID data attributes and submission process.

Recording Available

 

Implementation of Rapid Microbial Methods for Air and Water Monitoring in Pharmaceutical Industry

webinar-speaker   Igor Gorsky

webinar-time   2 hrs

Product Id: 704560

This training program will dispel mistaken paradigms regarding the risk based approach to introduction of rapid microbial detection systems for water systems. Attendees will understand how to validate and transfer LIF method and how to validate LIF instrument against currently used methods.

Recording Available

 

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