Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
Dr. Afsaneh Motamed Khorasani
60 Min
Product Id: 705583
Good documentation Practices (GDP) is an essential factor that needs to be closely followed by the personnel in any regulated environment as a process for a successful project completion including observations of unanticipated responses that are required to be accurately recorded and verified. This 60-min Webinar covers the essentials of GDP, its definition, purpose, and importance. Then expands on general rules and principles of GDP (US & EU), General tips for Laboratory Notebook documentation and finally discussing GDP enforcement by regulatory bodies in different countries with some examples of FDA citations.
Sample Size Determination for Design Validation Activities
Steven Wachs
90 Min
Product Id: 705852
Statistical Methods are typically used to ensure that product performance, quality, and reliability requirements are met during the Design Validation phase of product development. This webinar discusses common elements of sample size determination and several specific sample size applications for various design validation activities including Reliability Demonstration/Estimation, Acceptance Sampling, and Hypothesis Testing.
Deviation Investigation Best Practices: Ensuring Correct Content and Conclusions
Michael Ferrante
90 min
Product Id: 703538
This webinar will help attendees understand the fundamental steps of a deviation investigation with focus on using facts and objective evidence to arrive at root cause and CAPA. Learn how to identify and avoid potential pitfalls during deviation investigations.
Preapproval Inspection and Submission to the FDA
John E Lincoln
90 Min
Product Id: 706998
This webinar is intended to provide guidance regarding the FDA program to approve an NDA or an ANDA or PMA only if the methods used in, and the facilities and controls used for, the manufacture, processing, packing, and testing of the drug or Class III device are found adequate to ensure and preserve the drug's identity, strength, quality, and purity, or the device's safety and performance.
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.
Implementing Human Factors in Manufacturing
Ginette M Collazo
90 Min
Product Id: 706999
This course on Implementing Human Factors in Manufacturing provides a comprehensive overview of how to integrate human factors principles into manufacturing processes to reduce errors, improve safety and quality, and enhance operational efficiency. Participants will learn about the types and causes of human errors, ergonomic design principles, human-machine interface optimization, and effective strategies for fostering a culture of safety, quality, and continuous improvement. Through interactive workshops, case studies, and practical applications, attendees will gain the tools needed to conduct human factors assessments, design effective training programs, and develop actionable plans for sustainable improvement in their organizations.
How to Prepare a Standard Operating Procedure (SOP)?
Dr. Afsaneh Motamed Khorasani
60 Min
Product Id: 705131
This webinar will detail a step-by-step procedure on how to write a practical, effective and compliant Standard Operating Procedures (SOPs), review and revise SOPs and maintain compliance over the course of the SOP life-time.
Installation and Qualification of the Packaging Lines
John E Lincoln
90 Min
Product Id: 706996
Both the U.S. FDA and EU's MDR expect documented risk-based IQ, OQ, an PQs of medical packaging lines under U.S. FDA cGMP, EU MRD, ICH Q7 and Q9 and ISO 14971
Calibration and Validation of Equipment
John E Lincoln
90 Min
Product Id: 707002
Both the U.S. FDA and EU's MDR expect documented calibration and risk-based V&V under U.S. FDA cGMPs, the EU MDR, ICH Q9 and ISO 14971
Function, Preparation and Execution of Job Aids in the Pharmaceutical Industry
Michael Esposito
90 Min
Product Id: 707001
Learn how to effectively develop, prepare, and execute job aids in the pharmaceutical industry. This webinar covers the key characteristics of job aids, their purpose, use in training, and their role in qualifying individuals for independent tasks. Understand the importance of document hierarchies, skill checks, and how to train others to deliver job aid training.
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).
EU Medical Device Regulation 2017/745
Juan M Campos
90 Min
Product Id: 707003
Compliance with European Medical Device Regulation 2017/745 (MDR) is mandatory for all medical devices placed in the market in any member state of the European Union. It is of strategic importance for any medical device manufacturer to understand and effectively apply the MDR requirements to access this critical market.
Designing an Effective Cleaning Validation for Reusable Medical Devices in Today's Regulatory Environment
Gerry O Dell
90 Min
Product Id: 701929
This training will review the best practices establishing and conducting a cleaning validation for reusable medical devices. It will also address the requirements of ANSI/AAMI ST 98.
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.
Conducting Effective Quality Audits: Beyond Audit Checklists
Michael Ferrante
60 Min
Product Id: 703539
This webinar will teach attendees best practices for conducting effective quality audits to ensure regulatory compliance. Learn how to avoid potential pitfalls during the audit process.
FDA Bioresearch Monitoring Inspection Program 2024
David L Chesney
90 Min
Product Id: 706994
This webinar presents a survey of the FDA’s Bioresearch Monitoring Program, a series of FDA inspection programs covering regulatory inspections by the FDA of clinical trial sites, sponsors and Clinical Research Organizations, nonclinical testing laboratories, Institutional Review Boards (IRBs) and post marketing adverse event reporting requirements.
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.
US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus
Robert J Russell
90 Min
Product Id: 702029
This ICH GMP 90-minute webinar will provide your company the opportunity for comprehensive understanding of ICH Drug / Biologic GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan). It will cover the key areas of how ICH was established, it’s goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.
Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)
Steven Wachs
75 Min
Product Id: 705020
This webinar discusses methods for estimating process capability for both normal and non-normal data. Methods include estimating the proportion of defective products that may be produced as well as the calculation and use of common process capability indices (e.g. Cpk and Ppk). Process Capability assessments are discussed in the overall context of quality improvement/management.
GAMP Data Integrity 21 CFR Part 11 Training Course
Kelly Thomas
90 Min
Product Id: 706912
This course will cover data integrity, electronic records and signatures, and the compliant operation of GxP Computerized Systems to provide the tools and techniques to implement proper controls for data to ensure the integrity and validity of the information throughout the data lifecycle.