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Statistical Process Control (SPC) One Day Masterclass
MP3 Download This seminar will provide attendees with the statistical tools necessary to monitor processes to ensure the quality of manufactured products
Elaine Eisenbeisz Elaine Eisenbeisz
$996
21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures
MP3 Download 21 CFR Part 11, FDA's Guidance for Electronic Records and Electronic Signatures
Carolyn Troiano Carolyn Troiano
$249
FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control
MP3 Download This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pharmaceutical laboratory
Kelly Thomas Kelly Thomas
$229
Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course
MP3 Download Pharmacovigilance Auditing Inspection course will explain how to prepare for the audit inspection, overview of the European Medicines Agency's Guid
Michael Ramcharan Michael Ramcharan
€2.995
GMP Auditing for Quality Assurance Training Course for FDA Regulated Industries
MP3 Download GMP Auditing for the Pharmaceutical Industry
Kelly Thomas Kelly Thomas
$1,495
Developing Training in Regulated Environments
MP3 DDownload This webinar will explore the area of training in regulated environments, its importance, and its relationship to compliance documentation
Charles H. Paul Charles H. Paul
$995
DHF, DMR, DHR, Technical Documentation for US FDA, ISO and EU MDR Requirements
MP3 Download This Webinar will discuss the latest U.S. FDA and European Union requirements on Design History File, and Technical File/Design Dossier
John E Lincoln John E Lincoln
$199
Risk-Based Approach to CSV, 21 CFR Part 11 and FDA Compliance Webinar
MP3 Download This course will provide a condensed overview of the key practices that deliver the best results by directing the attendees
Carolyn Troiano Carolyn Troiano
$249
The Human Error Toolbox: a practical approach to human error
MP3 Download This course offers practical approaches and tools to address human performance issues in GMP related environments
Ginette Collazo Ginette Collazo
$249
FDA Compliance and Enforcement Trends focused on Data Integrity
MP3 Download This course will enable you to best anticipate and prepare for FDA scrutiny, understand your role during inspections and audits
Carolyn Troiano Carolyn Troiano
$249
A Culture of Quality is a Competitive Advantage
MP3 Download This webinar will help you to imbed a culture of quality throughout your organization. We will discuss concepts for creating a culture of quality
Susanne Manz Susanne Manz
$299
FDA Computer System Validation ( CSV) Training 3 Days Virtual Seminar
MP3 Download This Course will explain how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11.
Carolyn Troiano Carolyn Troiano
$1,294.97
Preventing Human Error in the Life Sciences
MP3 Download This eight-hour 4-hour per day virtual seminar, will explore the true causes and nature of human error
Charles H. Paul Charles H. Paul
$1,295
Post Market Surveillance - Complaint Handling and Medical Device Reporting
MP3 Download This webinar will cover the basics of complaint management and medical device reporting
Susanne Manz Susanne Manz
$299
Data Integrity by Design, Pharma 4.0 and Overcoming DI issues in the Cloud
MP3 Download This webinar will show how exactly is Data Integrity by Design important for achieving Pharma 4.0 and how its implementation can overcome issues of cloud computing.
Carolyn Troiano Carolyn Troiano
$249
Design Controls for Medical Devices
MP3 Download This 3-hour webinar will cover the basics of design controls for medical devices
Susanne Manz Susanne Manz
$299
FDA Compliance and Mobile Applications Best Practices for Ensuring Compliance
MP3 Download You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed
Carolyn Troiano Carolyn Troiano
$249
Reduce costs for compliance with data integrity: 21 CFR Part 11, SaaS/Cloud, EU GDPR
MP3 Download The instructor addresses the latest computer system industry standards for data security, data transfer, audit trails, electronic records and signatures, software validation, and computer system validation.
David Nettleton David Nettleton
$1,995
6 Hours Annual Online Human Error Certification Training Program
MP3 Download this training would provide tools that can be implemented and used after this event.
Ginette Collazo Ginette Collazo
$499
"Zero Defects" and the cGMPs - Pros and Cons
MP3 Download The last few years have seen several major "names" in drugs and devices stumble over quality and cGMP issues, resulting in recalls, lawsuits, and even possible criminal prosecution
John E Lincoln John E Lincoln
$199
Raw Material Requirements (Health Canada/USP/EP) in a cGMP Environment - Issues and Solutions Virtual Training
MP3 Download The objective of this FIVE HOUR/DAY, ON-LINE two day interactive seminar is to explore raw materials and their requirements – issues and solutions.
Barry A. Friedman Barry A. Friedman
$1,496
Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines
MP3 Download This 2-day seminar will explain the new Analytical Procedure Lifecycle guidelines and give attendees the knowledge needed to implement recommend
Kelly Thomas Kelly Thomas
$1,495
Writing and implementing a Standard Operating Procedure (SOP) in a Compliant Laboratory (US FDA, US EPA and OSHA Focus)
MP3 Download This seminar will describe the requirements, the dos and don’ts commonly performed by laboratories, the writing of a Standard Operating Procedure
John C. Fetzer John C. Fetzer
$995
Good Clinical Practice (ICH GCP) Course : Core Requirements, Expectations and Challenges
MP3 Download This webinar is intended to help you adequately implement Good Clinical Practices (GCP) including documentation requirements
John E Lincoln John E Lincoln
$595
GMPs for the Life Sciences – 12-Hour Virtual Seminar
MP3 Download This training will provide foundation to your GMP training.
Charles H. Paul Charles H. Paul
$1,295
FDA Recalls - Before You Start, and After You Finish
MP3 Download this seminar will help you to Understand FDA's recall authority and policy , Learn how to manage recalls under FDA oversight.
Kelly Thomas Kelly Thomas
$1,495
Comprehensive Overview of FDA Regulatory Compliance for Drug and Biotech Product
MP3 Download 2 Day Virtual Seminar
Karl M. Nobert Karl M. Nobert
$1,395
Death by CAPA - Does your CAPA Program need a CAPA?
MP3 Download This seminar will cover regulatory expectations, the myths, and the challenges of managing CAPAs so you can avoid common problems and pitfalls
Susanne Manz Susanne Manz
$850
Regulatory Compliance for Dietary Supplements in the US, EU and Canada
MP3 Download This 2-day interactive virtual seminar will review the regulations that impact Dietary Supplements in the US, EU and Canada and discuss how to verify that products
Travis Austin MacKay Travis Austin MacKay
$1,496
Aseptic Processing in the Manufacture of Biotech and Pharmaceutical Products 2 Day Course
MP3 Download The objective of this live, interactive WCS training seminar is to explore the role of aseptic filling to assure that manufactured product
Barry A. Friedman Barry A. Friedman
$1,895
FDA’s Regulation of OTC Drug Products : What It Is, How to Analyze It, Make It Work for You
MP3 Download this training will Gain a comprehensive understanding of how OTC Drug Products are regulated in the U.S. Pharmaceutical and Biotech.
Karl M. Nobert Karl M. Nobert
$1,295
Full Day Virtual Seminar on Fundamentals of Pharmacokinetics
MP3 Download The course will describe the processes that a drug undergoes after administration such as the absorption
Dr. Stefano Persiani Dr. Stefano Persiani
$795
U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs
MP3 Download This webinar will examine the existing and proposed requirements for the U.S. FDA’s DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3
John E Lincoln John E Lincoln
$499
Annual Product Quality Reviews; Preparation & Reports - FDA, EU, & Canada Regulatory Requirements
MP3 Download In this live training webinar we will discuss the world-wide regulatory requirements for Annual product Reviews (or Product Quality Reviews).
John G. Lanese John G. Lanese
$399
Supervising a Human Error Free Environment: You can do a Lot More than you Think
MP3 Download How can we prevent human error? This 90 -minutes online course will discuss why supervision is so important in reducing and preventing human error
Ginette Collazo Ginette Collazo
$179
Extractables & Leachable in Drug Development
MP3 Download In this webinar expert speaker Stefano Persiani will focus on the basics of an effective extractables and leachables program
Dr. Stefano Persiani Dr. Stefano Persiani
$199