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Drug Development: Key to Success from Concept to Commercialization
Aug 03 -04 2021 This 2 Day Virtual Seminar is designed to teach employees of pharmaceutical companies who would like an understanding
Karl M. Nobert Karl M. Nobert
$1,299
21 CFR Part 11 Compliance for Computer Systems Regulated by FDA
03 Aug This webinar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records
Carolyn Troiano Carolyn Troiano
$199
SaaS/Cloud Risk-Based Validation With Time-Saving Templates
03 Aug 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
$249
What do the FDA, EMA and PMDA Look for When Conducting cGMP Regulatory Inspections
04 Aug 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
Purchasing Controls, Receiving Inspection, and Supplier Audit – what to do during a global pandemic
5 Aug 2021 This webinar will provide insights into how to use remote auditing techniques to minimize the risk and maximize the benefits of conducting audits
Susanne Manz Susanne Manz
$199
Multiplicity: When and How to Adjust for Multiple Testing
5 August 2021 this webinar will explain the differences between family wise error rate (FWER) and false discovery rate (FDR).
Elaine Eisenbeisz Elaine Eisenbeisz
$249
Good Clinical Practice (GCP) Refresher Training
06 Aug This webinar is intended to help you adequately implement Good Clinical Practices (GCP) including documentation requirements
John E Lincoln John E Lincoln
$399
Data Integrity and Data Governance for Computer Systems Regulated by FDA
10 Aug This webinar will help you understand in detail the application of FDA’s guidelines for Computer System Validation
Carolyn Troiano Carolyn Troiano
$240
GMP Environmental Monitoring for Pharmaceutical Clean Rooms
10 August 2021 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
Quality by Design for Medical Devices Live Webinar
12 Aug This webinar can help you create a design control process that is a competitive strength for your company.
Susanne Manz Susanne Manz
$699
Computer System Validation (CSV) vs. Computer Software Assurance (CSA): Following a Waterfall vs. Agile Methodology
11 Aug 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
$240
FDA Recalls - Before You Start, and After You Finish
On 12 - 13 Aug, 2021 this seminar will help you to Understand FDA's recall authority and policy , Learn how to manage recalls under FDA oversight.
Kelly Thomas Kelly Thomas
$1,295
Technical Writing for professionals in the life sciences
August 16-18 This virtual seminar will walk you through the technical writing process from start to finish. Each critical aspect of writing technical documents for the life sciences
Charles H. Paul Charles H. Paul
$4,995
Deviation Management – Why have we not solved the problem?
17 Aug 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
18 August 2021 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
FDA Computer System Validation ( CSV) Training 3 Days Virtual Seminar
Aug 18-20 This Course will explain how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11.
Carolyn Troiano Carolyn Troiano
$1,295
Computer System Validation Professional Certification Program 3 Days
August 18-20 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
Computer System Validation Professional Certification Program 3 Days
August 18-20 3 day CSV course will teach you how to comply with key FDA and international CSV regulations and guidance, such as 21 CFR Part 11 and Annex 11.
Carolyn Troiano Carolyn Troiano
$1,295
Audits in the World of COVID-19 and Beyond: Are You Ready for Remote Audits?
19 August 2021 The presentation will provide an insight and guidance to managers with QA departments to implement a Remote Auditing program
Michael Ramcharan Michael Ramcharan
$229
Statistics for Process Control
19 Aug 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
Statistics for Process Control
19 Aug 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
A Comprehensive View of Medical Device Post-Market Regulations and Challenges During COVID-19— Complaint Handling, MDR Reporting and Recalls
On August 19-20, 2021 this course will explain how to comply with complicated Complaint Handling, MDR and Recall requirements. Earl Bird. Register.
Rita Hoffman Rita Hoffman
$1,599
Hypothesis Testing, p-values, and Inference: When Thinking Like a Statistician Makes Sense
24 August 2021 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
Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data
On 24 August 2021 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
Good Documentation Practices
On 25 Aug 2021 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
U.S. FDA and EU Medical Device Directive Requirements for DHFs, DMRs, DHRs, and TF/DDs
On 25 August 2021 This webinar will examine the existing and proposed requirements for the U.S. FDA’s DHF, 21 CFR 820.30 and now ISO 13485:2016 7.3
John E Lincoln John E Lincoln
$399
Human Factors/ Usability Studies following ISO62366 and the new FDA Guidance
On 25 August 2021 This webinar will conforms to the new ISO 62366 standard and the new FDA Guidance document.
Edwin Waldbusser Edwin Waldbusser
$265
Computer System Validation Boot Camp®
Sep 06- 10, 2021 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®
August 23- 27, 2021 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
3 Hrs Virtual Webinar on Aseptic Processing and Validation
On 02 September This course will provide an overview of requirements for aseptic and bulk manufacturing operations, including facility design and contamination
Kelly Thomas Kelly Thomas
$299
Project Management for Non-Project Managers
September 7 & 8 This virtual seminar will address those project management critical tasks within each project phase that must be performed flawlessly for effective project execution
Charles H. Paul Charles H. Paul
$1,495
Advanced Pharmacovigilance Auditing and Inspections Virtual Live Training Course
13-14 Sept 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
$1,899
Post Market Surveillance - Complaint Handling and Medical Device Reporting
16 Sep This webinar will cover the basics of complaint management and medical device reporting
Susanne Manz Susanne Manz
$229
Preventing Human Error in the Life Sciences Virtual Seminar (4 hours)
21 Sep 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
GMPs for the Life Sciences – 12-Hour Virtual Seminar
October 5, 6, 7 This training will provide foundation to your GMP training.
Charles H. Paul Charles H. Paul
$1,495
Write it Right – Standard Operating Procedures
On 05 October 2021 this webinar will help you to write complete, clear, unambiguous, and flexible SOPs.
Susanne Manz Susanne Manz
$229