Category:
Author:
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
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
$229
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
27-28, 2022 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
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
Computer System Validation Boot Camp®
Dec 13-15 , The course moves quickly and participants will change gears often to keep interest high and accommodate multiple learning styles
Carolyn Troiano Carolyn Troiano
$1,295
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
Statistics for Process Control
07 Dec This seminar will provide attendees with the statistical tools necessary to monitor processes to ensure the quality of manufactured products
Elaine Eisenbeisz Elaine Eisenbeisz
€795
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
Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program
MP3 Download This course will give an introduction into the Medical Device Single Audit Program (MDSAP) and how to adjust your internal audit program
Frank Stein Frank Stein
$429
Risk-Based Approach to Part 11 Compliance and Policies and Procedures to Support GxPs
MP3 Download This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle
Carolyn Troiano Carolyn Troiano
$392
Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance
MP3 Download This webinar will conforms to the new ISO 62366 standard and the new FDA Guidance document.
Edwin Waldbusser Edwin Waldbusser
$265