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Quality and GMP Compliance for Virtual Companies (Pharmaceutical and Biologics Industries)
June 05-06 In this two day workshop conference you will learn the requirements and expectations of major health care regulators that are applicable to "virtual" companies
Kelly Thomas Kelly Thomas
$1,295
The Project Management Plan
June 06 This webinar will introduce the concept of planning and how it is conducted. During the webinar
Charles H. Paul Charles H. Paul
$299
The DHF, DMR, DHR, EU MDR Technical Documentation Similarities, Differences and The Future
June 05 This seminar will examine the existing and proposed requirements for the U.S. FDA's DHF - including its derivative documents, the DMR, and DHR. It will consider the European Union's new MDR
John E Lincoln John E Lincoln
$499
Investigating Out-of-Specification (OOS) Test Results in the Laboratory; FDA Guidance and Latest Expectations Training
June 06 The objective of this live training webinar is to develop an understanding of how a compliant laboratory handles the investigation of OOS test
Kelly Thomas Kelly Thomas
$389
Mobile Device Apps and the FDA – Classification, Regulatory Requirements and Cybersecurity
June 07 This has resulted in the FDA focusing on the subset of software functions dealing with medical issues which the Agency intends to apply its authority
John E Lincoln John E Lincoln
$265
Project Management for Non-Project Managers – PM in the Life Sciences – Pharmaceutical/ Biotechnology and Medical Devices
June 12-14 This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective
Charles H. Paul Charles H. Paul
$1,295
Analytical Method Validation, Verification and Transfer
Jun 07-08 In this course, general guideline for the determination of the analytical characteristics for different types of validation procedures
Kelly Thomas Kelly Thomas
$1,495
US FDA Labeling Requirements for Medical Devices
June 08 In this webinar, including some little known or controlled areas which are subject to regulatory scruinty
John E Lincoln John E Lincoln
$265
FDA's regulation of Promotion and Advertising
June 08 The seminar will cover topics that equip you with the knowledge and skills required to avoid the FDA’s enforcement hammer
Casper (Cap) Uldriks Casper (Cap) Uldriks
$799
The 6 Most Common Problems in FDA Software Validation and Verification
Jun 13 This webinar covers the fundamentals of 21 CFR Part 11, software validation, and computer system validation
David Nettleton David Nettleton
$399
2 Day Virtual Seminar on FDA Inspection Essentials in 2023
June 13-14 This seminar, you will learn how to properly alert key members that an investigator has arrived, the proper protocol
Danielle DeLucy Danielle DeLucy
$1,495
Promoting and Advertising Dietary Supplements in Compliance with FDA and FTC Regulations
June 21 This webinar will review the applicable regulations, walk you through real-life situations, help you address compliance, and provide practical strategies to mitigate enforcement actions
Travis Austin MacKay Travis Austin MacKay
$399
Hypothesis Testing, p-values, and Inference: When Thinking Like a Statistician Makes Sense
June 22 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
$299
Writing and implementing a Standard Operating Procedure (SOP) in a Compliant Laboratory (US FDA, US EPA and OSHA Focus)
June 22-23 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
$1,495
The Quality System Regulation (cGMP, 21 CFR 210 & 211 and 820)
July 05 This webinar will examine the 14 key elements of the Medical Device CGMPs, 21 CFR 820, the Quality System Regulation
John E Lincoln John E Lincoln
$249
Efficient Batch Record Review and Product Release Course
July 06 Duration 240 Minutes
Danielle DeLucy Danielle DeLucy
$599
Risk management in the medical device industry
July 06 The seminar will explore the basic principles of risk management and planning as they relate to medical device design and as required by the FDA
Charles H. Paul Charles H. Paul
$499
Inspection and Audit Readiness Training for Medical Device Manufacturers
July 07 This course focuses on identifying FDA inspection criteria, resources (including key standard operating procedures such as CP 7382.845)
John E Lincoln John E Lincoln
$699
Modeling and Optimizing Process/Product Behavior Using Design of Experiments
July 11 This webinar will review the key concepts behind Design of Experiments
Steven Wachs Steven Wachs
$199
Strategies for Substantiating Structure-Function Claims for Dietary Supplements in the United States
July 12 The Federal Food, Drug, and Cosmetic Act requires that a manufacturer of a dietary supplement making a nutritional deficiency
Travis Austin MacKay Travis Austin MacKay
$399
Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course
July 12-13 | Aug 24-25 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
$1,495
21 CFR Part 11 and Annex 11; what you need to know to pass the new regulatory inspections
July 18 This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted
David Nettleton David Nettleton
$299
Auditing and Qualifying Suppliers and Vendors - An Effective Risk Based Approach
July 17-18 This eight-hour vendor qualification audit training will help you improve
Kelly Thomas Kelly Thomas
$1,199
Writing Standard Operating Procedures (SOP) Course Online & Certificate for FDA-Regulated Industry
Aug 01-03 This course will address how to write effective Standard Operating Procedures and Work Instructions in support of company activities
Kelly Thomas Kelly Thomas
$1,395
GCP/GLP/GMP : Comparison and Understanding of the FDA’s 3 Major Regulations
Aug 02 This seminar will define what are the US FDA's expectations for proper laboratory / clinical / manufacturing practices, systems, equipment usage
John E Lincoln John E Lincoln
$699
Determining and Managing your Project Risk – The Risk Analysis
Aug 03 This webinar will discuss project risk – how to identify it, how to quantify it, how to mitigate it, and how to prevent it from being realized
Charles H. Paul Charles H. Paul
$299
Technical Writing Course – Tech writing in the life sciences – get it right
Aug 07-09 This virtual seminar will begin with a general discussion of technical writing and its role within the life sciences
Charles H. Paul Charles H. Paul
$1,295
US Dietary Supplements - Regulatory Compliance Requirements, Product Claims, Labeling Issues and FDA Updates
Aug 08 This 120 minute training will review the dietary supplement regulations and discuss how to verify that your products are compliant
Travis Austin MacKay Travis Austin MacKay
$399
Lifecycle Management of Analytical Methods and Procedures - according to new FDA and USP guidelines
Aug 07-08 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
$1,295
FDA Computer System Validation ( CSV) Training 3 Days Virtual Seminar
Aug 14-15 This Course will explain how to comply with key FDA and international CSV regulations
Carolyn Troiano Carolyn Troiano
$1,699
Using Excel Spreadsheets in FDA Regulated Environment
Aug 15 This session will make you a better Excel user, saving you time and costs
David Nettleton David Nettleton
$299
Process Validation Guidance Requirements (FDA and EU Annex 15: Qualifications and Validation)
Aug 17-18 The lifecycle concept, new to these Guidance, link product and process development, qualification of the commerc
Barry A. Friedman Barry A. Friedman
$1,199
Stability Studies and Est Shelf Life
Aug 22 This webinar discusses the steps to design a stability study and analyze the results to estimate the product's shelf life
Steven Wachs Steven Wachs
$499
Managing Risks in Combination Products and Drug Delivery Systems
Aug 23 This seminar will provide valuable guidance to regulated companies in the development
John E Lincoln John E Lincoln
$699
Risk Management of Raw Materials in a GMP Environment
Aug 24-25 The live training webinar will explore the number of lots required to be tested before reduced testing might occur
Barry A. Friedman Barry A. Friedman
$1,199
Project Management for Non-Project Managers – PM in the Life Sciences – Pharmaceutical/ Biotechnology and Medical Devices
Aug 29-30 This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective
Charles H. Paul Charles H. Paul
€1.495