FDA Regulations on Usage of New Pharmaceutical Agents to Fight Infection
Thomas Webster
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.
US, EU, Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus
Robert J Russell
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.
Integration of ERP and Legacy FDA-Regulated Systems
Carolyn Troiano
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.
Applying SAS Program Validation Techniques Using Proc Tabulate to QC Summary Tables
Sunil Gupta
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.
CAPA Investigations - Tools for a Compliant and Effective Investigation Process
Carlos Rodriguez Garcia
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.
Discussion of Revisions Contained in ISO 13485:2016
Edward Kimmelman
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.
4-Hour Virtual Training: FDA Regulations for Marketing and Labeling OTC Drugs in the U.S.
Norma Skolnik
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.
3D Printing for Manufacturing Regulated Products: FDA's Current Acceptance and Future Projections
Mukesh Kumar
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.
3-Hour Virtual Training: Russia Regulatory Compliance Requirements for Life Science Products
Robert J Russell
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.
Educating and Training Staff to Manage Regulatory Records
Charlie Sodano
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.
GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry
Angela Dunston
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.
FDA Inspection Preparedness
Susan Muhr Leister
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.
Creating Proper User Requirement Specifications (URS) for Computer Systems Validation (CSV) - Ensuring Overall Regulatory Compliance
Gaurav Walia
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.
Process Robustness: The New FDA Paradigm
Angela Dunston
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.
Using Analysis of Variance - A Practical Approach
Daniel O Leary
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.
How to Properly Monitor Process and Performance of Pharmaceutical Solid Dosage Equipment
Michael Levin
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.
Pharmaceutical Water Use and Monitoring
Igor Gorsky
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.
Introduction to the FDA and Your First FDA Meeting
Andrew S Verderame
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.
How to Survive FDA's New Inspection and Enforcement Practices
Dr. Ludwig Huber
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.
FDA's Expectations from Supplier Management for GMP: Quality Agreements and More
Mukesh Kumar
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.