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

€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

$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

$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

$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

$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

$1,295

Annual Current Good Manufacturing Practices (cGMP) Training

MP3 Download This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement

Kelly Thomas

$229

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

$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

€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

€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

$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

$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

$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

$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

$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

$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

$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

$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

$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

$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

€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

$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

$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

$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

$499

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

$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

$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

$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

$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

$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

$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

$265

Building a Compliant Laboratory – From Foundation to Business Excellence

MP3 Download In this webinar speaker will define compliance, provide a translation of regulations and guidance into user requirements .

David W. Husman

$199

Power Analysis for Sample Size Calculations

MP3 Download In this webinar speaker will explain how to put the power analysis techniques to use will help to assure that you’ll collect a large enough sample

Elaine Eisenbeisz

$249

Management Review to ensure a Suitable and Effective Quality Management System

MP3 Download this course, we’ll discuss how to improve awareness, focus, and a culture of quality

Susanne Manz

$199

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

€1.295