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Investigation of Out-of-Specification Test Results
MP3 Download Attendees will learn the FDA expectations when investigating out-of-specification and out-of-trend laboratory results.
Paul Larocque Paul Larocque
$265
Quality Control Laboratory Compliance - cGMPs and GLPs
Aug 11-12 This course will examine the fundamental requirements for all QC laboratories subject to FDA inspection, recent trends from FDA inspection reports and enforcement actions
Kelly Thomas Kelly Thomas
$1,495
The European PSMF
MP3 Download This course teaches you with evolution of the PSMF and the legislation concerning it for the EU, sections of the PSMF, annexes of the PSMF
Graeme Ladds Graeme Ladds
$249
Full Day Virtual Workshop Qualification (IQ, OQ, PQ) and Validation of Laboratory Equipment and Syst
MP3 Download This webinar will aim at understanding and scoping out various phases of Qualification activities that will be integrated
Joy L. McElroy Joy L. McElroy
$695
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
€1.895
Verification and Validation - Product, Equipment / Process, Software, QMS+
MP3 Download This seminar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning and Plan(s).
John E Lincoln John E Lincoln
$1,295
3 Hrs Webinar on What You Need to Know: Investigating Out-of-Specification (OOS)
MP3 Download This webinar will review the regulatory requirements for investigating an OOS Investigation.
Danielle DeLucy Danielle DeLucy
$399
2 Day Virtual Seminar on FDA Inspection Essentials in 2022
MP3 Download This seminar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol
Danielle DeLucy Danielle DeLucy
€1.295
Write it Right – Standard Operating Procedures
MP3 Download This webinar will help you to write complete, clear, unambiguous, and flexible SOPs.
Susanne Manz Susanne Manz
$487
What You Need to Know: Auditing EU-MDR and EU-IVDR Implementation
MP3 DowIoad this webinar you will learn about Auditing EU-MDR and EU-IVDR Implementation. We’ll share insights on the importance of good project management
David R. Dills David R. Dills
$399
Complaint Management: Best Practices to Assure Regulatory Compliance and Customer Retention
MP3 Download This session will include the requirements for all of the above responsibilities, which will include defining, documenting, and implementing
Jeff Kasoff Jeff Kasoff
$249
Writing Excellent SOPs Webinar
MP3 Download You will learn techniques for creating concise and easy to read SOPs that your employees can understand and will follow
Susanne Manz Susanne Manz
$179
Purchasing Controls, Supplier Management, and Receiving Acceptance for Medical Devices
MP3 Download This 2-day virtual seminar can help you understand your responsibilities in terms of Purchasing Controls enabling you to provide safe
Susanne Manz Susanne Manz
$1,295
Pharmaceutical Compressed Air Quality GMP Requirements - What you need to know to meet FDA and Inte
MP3 Download This webinar will give you an understanding of the different types of contamination inherent in compressed air
Roger Cowan Roger Cowan
$199
Computer System Validation Boot Camp®
The course moves quickly and participants will change gears often to keep interest high and accommodate multiple learning styles
Carolyn Troiano Carolyn Troiano
€2.800
The Veterinary Drug Approval Process and FDA Regulatory Oversight
MP3 Download This two-day seminar will provide attendees with an understanding of FDA’s veterinary drug approval process, obtaining federal government
Karl M. Nobert Karl M. Nobert
€1.295
FDA’s Ambitious Regulation of Social Media - New Course By FDA Investigator
MP3 Download This webinar teach us about social media platforms provide common ways to cross FDA’s legal boundaries for “misbranding” your product
Casper (Cap) Uldriks Casper (Cap) Uldriks
$229
3 Hrs Virtual Webinar on Aseptic Processing and Validation
MP3 Download This course will provide an overview of requirements for aseptic and bulk manufacturing operations, including facility design and contamination
Kelly Thomas Kelly Thomas
$299
Hypothesis Testing, p-values, and Inference: When Thinking Like a Statistician Makes Sense
MP3 Download You will learn the why and how of the scientific method, and how to view the world with a statistician’s eyes
Elaine Eisenbeisz Elaine Eisenbeisz
$499
FDA Inspections – Proven Preparation & Survival Techniques : What Regulators Expect and How to Prepare
MP3 Download This seminar will help you use the FDA inspection as a learning tool, not as a negative or adversarial experience.
Danielle DeLucy Danielle DeLucy
$3,995
Data Integrity: FDA, WHO and EMA's Requirements
MP3 Download This two day seminar is to explore and define the necessary elements in the development and implementation of a Data Integrity program
Barry A. Friedman Barry A. Friedman
$1,495
FDA’s Plan to Modernize the 510(k) Pathway: What Regulatory, Quality and Compliance Professionals Need to Know
MP3 Download This webinar will discuss the 510(k) framework to reflect advances in device technology, safety and capabilities, making it harder to obtain
John E Lincoln John E Lincoln
$287
3Hour Virtual Seminar on IEC 62304 and Demystifying Software Validation using the Principles of LDLC
MP3 Download This session will give you a good understanding of how the IEC 62304 differs from ISO 13485. It will also cover components of the Software
Jose Mora Jose Mora
$399
Multiplicity: When and How to Adjust for Multiple Testing
MP3 Download this webinar will explain the differences between family wise error rate (FWER) and false discovery rate (FDR).
Elaine Eisenbeisz Elaine Eisenbeisz
$249
Medical Device Cybersecurity and FDA Compliance
MP3 Download This webinar will focus on cybersecurity of medical devices, a key concern for those who develop, manufacture, test, and distribute these products
Carolyn Troiano Carolyn Troiano
$695
Audits in the World of COVID-19 and Beyond: Are You Ready for Remote Audits?
MP3 Download The presentation will provide an insight and guidance to managers with QA departments to implement a Remote Auditing program
Michael Ramcharan Michael Ramcharan
$229
Computer System Validation Professional Certification Program 3 Days
Dec 8-10 , 2021 This course will completely immerse you in computer system validation and delivers comprehension of the regulations impacting your system
Carolyn Troiano Carolyn Troiano
€1.295
Deviation Management – Why have we not solved the problem?
MP3 Download This seminar will discuss the reasons for deviation failures and provide solutions for success.
David W. Husman David W. Husman
$199
Marketing to Medicare or Medicaid Beneficiaries - What You Can and Cannot Do
MP3 Download This webinar will discuss the Federal Anti-Kickback Statute, what it prohibits, its penalties, its scope and its exceptions
William Mack Copeland William Mack Copeland
$199
GMP Environmental Monitoring for Pharmaceutical Clean Rooms
MP3 Download Attend this webinar to various US and international regulatory requirements, the testing requirements for the various clean room classifications
John E Lincoln John E Lincoln
$249
What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections
MP3 Download This webinar will cover the key areas of how ICH Q7 was established, it's goals and objectives, expectations of the healthcare authorities
Kelly Thomas Kelly Thomas
$499
US FDA Medical Device QSR, 21 CFR 820 and Quality Management System
MP3 Download Learn the basic overview of the original medical device Quality Management System
John E Lincoln John E Lincoln
$229
Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data
MP3 Download this webinar will cover all the items listed above, and more. If you want to improve your CAPA system, you cannot afford to miss this.
Jeff Kasoff Jeff Kasoff
$199
Data Integrity and Data Governance for Computer Systems Regulated by FDA
MP3 Download This webinar will help you understand in detail the application of FDA’s guidelines for Computer System Validation
Carolyn Troiano Carolyn Troiano
$240
Quality by Design for Medical Devices Live Webinar
MP3 Download This webinar can help you create a design control process that is a competitive strength for your company.
Susanne Manz Susanne Manz
$699
The FDA Inspection: Best Practices for Preparation, Behavior, and Response
MP3 Download This course provides medical device/pharmaceutical professionals with the information they need to prepare for and manage any type of FDA
Jeff Kasoff Jeff Kasoff
$179