WEBINARS

 

FDA Regulations and Guidance Training - Live Webinars, Recordings & CDs

FDA Regulations on Usage of New Pharmaceutical Agents to Fight Infection

webinar-speaker   Thomas Webster

webinar-time   2 hrs

Product Id: 704559

This training program will discuss fundamentals of infection and the use of materials/drugs to fight infection, FDA regulatory approvals for drugs and materials used to fight infection, and future thoughts on approaches to fight infection.

Recording Available

 

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

 

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

 

Applying SAS Program Validation Techniques Using Proc Tabulate to QC Summary Tables

webinar-speaker   Sunil Gupta

webinar-time   70 Min

Product Id: 704539

This training program is intended for 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. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be 21CFR Part 11 or Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this course.

Recording Available

 

CAPA Investigations - Tools for a Compliant and Effective Investigation Process

webinar-speaker   Carlos Rodriguez Garcia

webinar-time   60 Min

Product Id: 704039

This training program will provide professionals with essential elements of CAPA investigations to assure compliance with regulatory requirements. The corrective and preventive action (CAPA) program is an essential element of a compliant quality management system, as required by international regulations and voluntary standards. Investigations are the backbone of the CAPA program.

Recording Available

* Per Attendee $229

 

Discussion of Revisions Contained in ISO 13485:2016

webinar-speaker   Edward Kimmelman

webinar-time   90 Min

Product Id: 704506

The training program will prepare attendees to better understand the revisions to this standard as they read its requirements in detail. For those organizations that have a QMS that's compliant with ISO 13485:2003, you will benefit from this program as it will help you assess your preparations.

Recording Available

* Per Attendee $229

 

4-Hour Virtual Training: FDA Regulations for Marketing and Labeling OTC Drugs in the U.S.

webinar-speaker   Norma Skolnik

webinar-time   4 hrs

Product Id: 704530

The objective of this virtual training seminar is to assist attendees in understanding and being able to apply FDA regulations for OTC drugs and to label and market them successfully in the U.S. while avoiding regulatory problems. The program will also explore other verticals such as: OTC drug monographs and their importance to product marketing, a summary of OTC drug GMP regulations, FDA rules for adverse event reporting of OTC drugs, avoiding FDA Warning Letters, and more.

Recording Available

 

3D Printing for Manufacturing Regulated Products: FDA's Current Acceptance and Future Projections

webinar-speaker   Mukesh Kumar

webinar-time   60 Min

Product Id: 703621

The webinar will discuss the current available regulatory pathways to develop FDA-regulated 3D printed products and also predictions on what to expect in the near future. 3D printing in personalized treatments will be discussed and attendees will be provided practical tips for pursuing approval with the FDA.

Recording Available

* Per Attendee $229

 

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

 

Educating and Training Staff to Manage Regulatory Records

webinar-speaker   Charlie Sodano

webinar-time   60 Min

Product Id: 704493

This training program will explore why planning and implementing an information management solution can be a daunting task. Composing policies and procedures is a good start, followed by testing in small groups. But a lot of people are resistant to changing their work practices, especially if they have been working for an organization for a long time. The worst thing that can happen is that staff appears to be compliant with the new plan, but has found a way to continue their prior practices under the radar. The solution to this problem is a comprehensive initial and continuing educational plan.

Recording Available

* Per Attendee $229

 

GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry

webinar-speaker   Angela Dunston

webinar-time   90 Min

Product Id: 704454

This training program will discuss MHRA GMP data integrity definitions and guidance. It will also highlight the difference between intentional and unintentional failures of data integrity and examine how regulatory agencies detect data integrity problems.

Recording Available

* Per Attendee $229

 

FDA Inspection Preparedness

webinar-speaker   Susan Muhr Leister

webinar-time   60 Min

Product Id: 704221

This training program will discuss key terms and responsibilities related to FDA inspections and the purpose of the BIMO inspection program. It will also review the general purpose and overall process of an FDA inspection and enhance your inspection preparation strategies.

Recording Available

* Per Attendee $229

 

Creating Proper User Requirement Specifications (URS) for Computer Systems Validation (CSV) - Ensuring Overall Regulatory Compliance

webinar-speaker   Gaurav Walia

webinar-time   75 Min

Product Id: 704370

This training program will provide attendees with the ultimate set of tools in order to help their firms properly create User Requirement Specifications (URS) for Computer Systems Validation (CSV) with emphasis on current industry trends in this particular area as well as current Food and Drug Administration (FDA) regulatory trends and enforcement activity.

Recording Available

* Per Attendee $229

 

Process Robustness: The New FDA Paradigm

webinar-speaker   Angela Dunston

webinar-time   90 Min

Product Id: 703990

In this training program, attendees will learn how process robustness tools and metrics can be utilized to enhance process understanding and control. The new FDA paradigm is shifting to the expectation that organizations certified by other standards such as ISO and EFfCI demonstrate process robustness. It is the obligation of the primary pharmaceutical provider to ensure process robustness throughout the supply chain.

Recording Available

* Per Attendee $229

 

Using Analysis of Variance - A Practical Approach

webinar-speaker   Daniel O Leary

webinar-time   60 Min

Product Id: 703824

This training program will illustrate the underlying idea that makes ANOVA work. It will also offer an understanding of the data collection issues you should plan and how to get access to ANOVA in Excel.

Recording Available

* Per Attendee $229

 

How to Properly Monitor Process and Performance of Pharmaceutical Solid Dosage Equipment

webinar-speaker   Michael Levin

webinar-time   60 Min

Product Id: 704274

Among other key topics, this training program will focus on what can be monitored in mixing operations, wet granulation operations, dry granulation operations, compaction operations, and coating operations.

Recording Available

* Per Attendee $229

 

Pharmaceutical Water Use and Monitoring

webinar-speaker   Igor Gorsky

webinar-time   150 Min

Product Id: 704336

This training program will guide attendees on how to best deliver water from a high purity water distribution system. Attendees will learn to capitalize on the advantages of online analytical instrumentation and understand the value of rapid microbiological methods. The program will also offer an understanding of real-time release of water.

Recording Available

* Per Attendee $50

 

Introduction to the FDA and Your First FDA Meeting

webinar-speaker   Andrew S Verderame

webinar-time   60 Min

Product Id: 704338

This FDA training program will guide attendees on how to get the best advice from FDA with the proper actions before, during and after your FDA meeting.

Recording Available

* Per Attendee $229

 

How to Survive FDA's New Inspection and Enforcement Practices

webinar-speaker   Dr. Ludwig Huber

webinar-time   75 Min

Product Id: 704328

This training program will enumerate the inspection process for API, drug and device manufacturers and summarize recent changes. It will guide attendees on preparing staff for the new FDA inspections and discuss the role of exit meeting to avoid enforcement.

Recording Available

* Per Attendee $229

 

FDA's Expectations from Supplier Management for GMP: Quality Agreements and More

webinar-speaker   Mukesh Kumar

webinar-time   90 Min

Product Id: 703483

This webinar will review FDA’s regulations related to suppliers in manufacture of drugs, biologics and medical devices. It will discuss the current regulations, guidance documents and best practices for supplier management and enforceable quality agreement using case studies for a variety of scenarios. Common FDA audit findings will be discussed.

Recording Available

* Per Attendee $229

 

 

 

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