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The Microbiology of Water in a GMP Environment; USP, EP, JP and FDA Requirements for Potable Water, Purified Water, Water for Injection and Steam
MP3 Download This webinar will examine a variety of issues surrounding water in a facility to include the testing of each water source.
Barry A. Friedman Barry A. Friedman
$199
CMO Supplier Quality Agreements - What you need to know to comply with new FDA & EU GMP Guidelines for contract drug manufacture
MP3 Download This Webinar presentation will provide a thorough understanding of the content that is expected in Quality Agreements from a regulatory
Roger Cowan Roger Cowan
$299
Developing an Effective Strategy for Testing Raw Materials in Phase 1 Through Phase 3 Environment
MP3 Download This live training will cover testing requirements during each Phase and what may be optional until the product moves to its next Phase
Barry A. Friedman Barry A. Friedman
$299
Marketing, Advertising and Promotion of Pharmaceuticals and Medical Devices
MP3 Download The seminar will provide attendees with a better understanding of responsibilities and gain a greater knowledge of the issues faced
David R. Dills David R. Dills
$1,299
Good Documentation Practices
MP3 Download This presentation will discuss the purpose of good documentation, what proper documentation looks like and a brief discussion of elements
David W. Husman David W. Husman
$199
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
Preventing Human Error in the Life Sciences Virtual Seminar (4 hours)
MP3 Download This four hour virtual seminar, will explore the true causes and nature of human error, how human error should be investigated
Charles H. Paul Charles H. Paul
$599
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
$1,699
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
Cybersecurity - US FDA Requirements – New Course !
MP3 Download This webinar will consider how cybersecurity is introduced into the CGMPs, design control (21 CFR 820.30) for devices, and post-production
John E Lincoln John E Lincoln
$240
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
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
$229
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
$1,899
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
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
How FDA trains its investigators to review CAPA and what should you do to prepare
MP3 Download This webinar will discuss all the documents used by FDA to train their inspectors to review your CAPA system, some of which you may not be familiar
Jeff Kasoff Jeff Kasoff
$299
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
Risk Based Verification and/or Validation to meet US FDA CGMP and ISO 13485 Requirements
MP3 Download This Webinar will provide valuable assistance to all regulated companies that need to review and modify their Master Validation Planning.
John E Lincoln John E Lincoln
$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
$1,950
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
Computer System Validation (CSV) vs. Computer Software Assurance (CSA): Following a Waterfall vs. Agile Methodology
MP3 Download The attendee will learn about FDA’s approach to modernizing technology, and how that will benefit both the Agency and industry.
Carolyn Troiano Carolyn Troiano
$499
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
2 Day Virtual Seminar on FDA Inspection Essentials in 2021
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
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