The 6 Most Common Problems in FDA Software Validation and Verification
David Nettleton
120 Min
Product Id: 705582
This training on FDA software validation and verification will provide you the best practices necessary to ensure that all systems are validated in compliance with FDA regulations.
![](/images/products/large/706879.jpg)
The GLPs and Analytical Test Methods Validation
John E Lincoln
90 Min
Product Id: 706978
Both the U.S. FDA and EU's MDR expect documented risk-based device test method and design V&V under the GLPs, et al
![](/images/products/large/706884.jpg)
Managing Microbiological Out of Specification (OOS) and Out of Trend (OOT) Results in Sterile and Non-Sterile Production FDA & ICH Expectations and Guidance
Barry A Friedman
90 Min
Product Id: 706884
The objective of this interactive, live training webinar is to explore the management of OOS practices and suggested avenues to take to minimize deviations, OOT, OOS and CAPA and how to attack these situations should they occur. It is also designed to determine how FDA and ICH regulations and guidances may impact them. It will also reference the new PDA TR 88, “Microbial Data Deviation Investigations in the Pharmaceutical Industry”.
![](/images/products/large/704531.jpg)
Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries
Joy McElroy
120 Min
Product Id: 704531
This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.
![](/images/products/large/706879.jpg)
US FDA Requirements for Medical Products Labeling / UDI
John E Lincoln
90 Min
Product Id: 706969
The U.S. FDA has several requirement for the labeling of medical products. The key requirements are in 21 CFR 801.
![](/images/products/large/705317.jpg)
Gaining and Re-establishing Control of Your Cleanroom
Joy McElroy
60 Min
Product Id: 705317
This webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case event.
Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
David Nettleton
90 Min
Product Id: 701687
This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
![](/images/products/large/706879.jpg)
The 510(k) Mod Program, Breakthrough Technologies, and STeP
John E Lincoln
90 min
Product Id: 706976
What are the U.S. FDA's recently expanded, less traditional / modified pathways for novel technologies or safer products to receive clearand or approval.
![](/images/products/large/700162.jpg)
Process Validation Requirements & Compliance Strategies
Jose Mora
60 Min
Product Id: 700162
This Process Validation Requirements webinar will review process validation basics, with emphasis on looking beyond compliance towards achieving a robust process. Review of process validation basics, with emphasis on looking beyond compliance towards achieving a robust process.
Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
David Nettleton
75 Min
Product Id: 701582
Learn how to use Microsoft Excel spreadsheets for GXP data to ensure compliance with 21 CFR Part 11 and reduce validation cost and time.
![](/images/products/large/706879.jpg)
Document the Clinical Evaluation Report (CER) for the EU MDR and CE Mark
John E Lincoln
90 Min
Product Id: 706985
To document the clinical evaluation of a medical device and its output, a Clinical Evaluation Report or CER has to be compiled. The CER is an ongoing compilation of the generation, appraisal, and analysis of clinical data related to a device. It is one of the major components of the Technical Documentation File.
![](/images/products/large/704315.jpg)
Acceptance Sampling Plans for Process Validation and Production Lot Monitoring
Steven Wachs
90 Min
Product Id: 704315
This webinar provides details regarding the generation of acceptance sampling plans often used in process validation and production control to ensure quality of final products. By attending this webinar, participants will be able understand the key inputs and issues involved in determining acceptance sampling plans. Sampling plans for attribute data are the primary focus although variable acceptance sampling plans are presented as well.
![](/images/products/large/706791.jpg)
Reconciling/Adapting the 8D Problem Solving Process for the Life Sciences
Charles H Paul
90 Min
Product Id: 706939
The 80 problem solving process developed by the Department of Defense and driven by Ford Motor Company is a worldwide method used to improve quality address customer complaints and issues quickly and efficiently. The process helps develop rapid response to customer issues and complaints and strengthens business relationship with those customers and regulatory bodies. The process helps improve quality and supports and promotes prevention rather than simply the detection of problems.
![](/images/products/large/706879.jpg)
US FDA's Cybersecurity and NIST Framework Requirementsfor Networks
John E Lincoln
90 Min
Product Id: 706971
Cybersecurity is the art of protecting networks, devices, and data from unauthorized access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information, and is a rapidly growing problem for industry.
![](/images/products/large/705422.jpg)
Annual Current Good Manufacturing Practices (cGMP) Training
Kelly Thomas
60 Min
Product Id: 705422
This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.
![](/images/products/large/706344.jpg)
Assess Impact For Supplier Change Notices
Alan M Golden
60 Min
Product Id: 706344
This webinar will discuss dealing with supplier change notices. Regulatory agencies have the expectation that a manufacturer has control over its supply chain and dealing with changes to that supply chain can be challenging.
![](/images/products/large/706879.jpg)
The eSTAR Submission Program for 510(k)s, IDEs, De Novos, PMAs, and Q-Submissions
John E Lincoln
90 Min
Product Id: 706968
The regulation and control of new or substantially changed medical devices for sale in the US is based on the 510(k), PMA or DeNovo submission process; 510(k)s now can only be submitted to the FDA under the eSTAR (electronic Submission Template And Resource) Portal. Other submissions will be phased in using new guidance templates as they become available.
![](/images/products/large/706965.jpg)
Quality Agreements and Their Role as Part of a Quality System
Michael Ferrante
90 Min
Product Id: 706966
This webinar will focus on the Process for Quality Agreements and requirements that must be implemented to ensure compliance with the latest quality and regulatory requirements. Attendees will learn the reason for implementing a Quality Agreement system to assure adequate controls for Service Providers.
![](/images/products/large/706879.jpg)
P&PC, SPC/6Sigma, Failure Investigation, Root Cause Analysis, PDCA, DMAIC, A3
John E Lincoln
90 Min
Product Id: 706963
This webinar is intended to provide guidance regarding the CGMPs on manufacturing methods utilizing the US FDA Production and Process Controls for Drugs and Devices and Statistical Process Controls (SPC) as taught by Drs. Demming and others and required also in the CGMPs and under control of variation process guidance.
![](/images/products/large/706879.jpg)
Design Control / Ddesign and Development Requirements / Documents Under 21 CFR 820/ ISO 13485 7.3
John E Lincoln
90 Min
Product Id: 706923
Proper adherence and documentation of the FDA's Design Control requirements are key to any medical product project's success.