WEBINARS

 

Life Sciences Regulatory Compliance Training - Live Webinars, Recordings & CDs

Risk-Based Verification and Validation Planning to Meet US FDA and ISO 13485 Requirements

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 700149

In this webinar attendees will learn both the U.S. FDA and EU's MDD/MDR expect documented risk-based "master" and "individual" V&V planning. Various validation terms are explained with useable “working” definitions. The Validation Master Plan, and suggested field-tested individual V&V plans, Test Report / Protocol formats, and individual test cases, IQ, OQ, and PQs, are presented.

26 / Sep / 2023 - Tuesday

* Per Attendee $229

 

Best Practices for Auditing a Vendor of Computer Systems Regulated by FDA

webinar-speaker   Carolyn Troiano

webinar-time   90 Min

Product Id: 706930

We will discuss the importance of applying industry best practices when auditing a vendor of hardware, software, or other technology, or a provider of technology services, such as system implementation, system configuration, system development, system integration or similar activity.

9 / Oct / 2023 - Monday

* Per Attendee $199

 

Predicting Product Life Using Reliability Analysis Methods

webinar-speaker   Steven Wachs

webinar-time   90 Min

Product Id: 702096

Achieving high product reliability has become increasingly vital for manufacturers in order to meet customer expectations amid the threat of strong global competition. Poor reliability can doom a product and jeopardize the reputation of a brand or company. Inadequate reliability also presents financial risks from warranty, product recalls, and potential litigation. When developing new products, it is imperative that manufacturers develop reliability specifications and utilize methods to predict and verify that those reliability specifications will be met. This presents a difficult challenge in many industries with short product cycles and compressed product development time frames. This webinar provides an overview of quantitative methods for predicting product reliability from data gathered from physical testing or from field data.

16 / Oct / 2023 - Monday

* Per Attendee $199

 

Estimating Reliability Performance with Accelerated Life Tests

webinar-speaker   Steven Wachs

webinar-time   90 Min

Product Id: 702095

This webinar on Estimating Reliability Performance of products will show how you can use Accelerated Life Testing methods (ALT) to reduce costs, minimize risks and ensure adequate product performance prior to launch.

13 / Nov / 2023 - Monday

* Per Attendee $199

 

Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

webinar-speaker   David Nettleton

webinar-time   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).

15 / Nov / 2023 - Wednesday

* Per Attendee $249

 

Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

webinar-speaker   David Nettleton

webinar-time   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.

13 / Dec / 2023 - Wednesday

* Per Attendee $229

 

Computer System Validation (CSV) vs. Computer System Assurance (CSA): Aligning the Agile Methodology to the GAMP®5 "V" Model and System Development Life Cycle (SDLC) Methodology

webinar-speaker   Carolyn Troiano

webinar-time   120 Min

Product Id: 706921

As part of the Case for Quality program US FDA Center for Devices and Radiological Health noted how an excessive focus by industry on compliance rather than quality may be diverting resources and management attention toward meeting regulatory compliance requirements vs. adopting best quality practices. There has also been a lower than anticipated investment in automation and digital technologies, which could greatly improve quality and process control. A key element is a risk-based, product quality and patient-centric approach to Computer System Assurance (CSA) vs. the traditional Computer System Validation (CSV) waterfall approach. This encourages critical thinking based on product and process knowledge and quality risk management over prescriptive documentation driven approaches.

This is where FDA determined that “WHAT” is required can be done (the “HOW”) in different ways and does not have to be according to the “checklist” mindset of most CSV work, where you create documents without specifically addressing the risk of potential failure of each requirement.

GAMP®5 supports the use of incremental, iterative, and evolutionary approaches including agile, for development of custom applications. Keys to success include a robust Quality Management System and well trained and highly disciplined teams following well-defined processes supported by tools and automation.

Recording Available

* Per Attendee $299

 

Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)

webinar-speaker   Steven Wachs

webinar-time   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.

Recording Available

* Per Attendee $299

 

Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing

webinar-speaker   Joy McElroy

webinar-time   90 Min

Product Id: 705929

In this cleaning validation webinar attendees will learn the Total Organic Carbon (TOC) feasibility, method validation and transfer from the laboratory to the manufacturing floor, as well as reviewing a feasibility study of multiple, difficult to oxidise or low solubility organic compounds.

Recording Available

* Per Attendee $299

 

Effective Systems for Change Control in the Pharmaceutical Industry

webinar-speaker   David L Chesney

webinar-time   90 Min

Product Id: 705002

This webinar will help you understand GMP requirements for change control from a pharmaceutical manufacturing perspective, the purpose of change control and what types of changes are or are not subject to change control. Participants will learn how to execute and implement a change in a regulated environment.

Recording Available

* Per Attendee $249

 

Advanced Auditing for Data Integrity

webinar-speaker   Joy McElroy

webinar-time   90 Min

Product Id: 705275

This training program will teach attendees best practices on how to perform audits for data integrity within their organization. Attendees will also learn how to centralize management and eliminate silos.

Recording Available

* Per Attendee $249

 

Acceptance Sampling Plans for Process Validation and Production Lot Monitoring

webinar-speaker   Steven Wachs

webinar-time   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.

Recording Available

* Per Attendee $249

 

Computer System Validation and Part 11 Compliance

webinar-speaker   Joy McElroy

webinar-time   60 Min

Product Id: 705427

This webinar will discuss in detail the requirements of 21 CFR part 11 and updated European Annex 11 regulation including requirements for local, SaaS, and cloud hosting. It will also offer techniques to implement a computer system using risk-based validation to gain maximum productivity and reduce cost by as much as two thirds.

Recording Available

* Per Attendee $249

 

Medical Device Process Validation Training for Professionals

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 701662

This 90-minute session on risk-based verification and validation planning will discuss "must have" elements from the U.S. FDA cGMP, EU MDR, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.

Recording Available

* Per Attendee $249

 

Trial Master File and Clinical Data Management Regulated by FDA

webinar-speaker   Carolyn Troiano

webinar-time   60 Min

Product Id: 705360

This FDA compliance training will cover in detail the new requirements for trial master files including documents related to clinical trials that are required to be prepared, collected and maintained as part of the TMF.

Recording Available

* Per Attendee $249

 

Medical Device Change(s) and the 510(k)

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 701742

This 90-minute webinar will provide valuable assistance to all regulated companies performing and documenting meaningful, results driven 510(k) / change analysis activities, based on the FDA's new Draft Guidance, "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device", dated October 25, 2017.

Recording Available

* Per Attendee $299

 

Annual Current Good Manufacturing Practices (cGMP) Training

webinar-speaker   Kelly Thomas

webinar-time   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.

Recording Available

* Per Attendee $249

 

Human Factors/Usability Studies following ISO 62366 and the new FDA Guidance

webinar-speaker   Edwin Waldbusser

webinar-time   60 Min

Product Id: 704496

This training program will examine how human factors/usability is the analysis of how people interact with medical devices. The process of conducting rigorous human factors studies throughout the design process, integrating it with the device risk analysis and design process, and validating the effectiveness of the studies will be explained. The various types and methods of human factors analysis will be explained. This process conforms to the new ISO 62366 standard and the new FDA guidance document.

Recording Available

* Per Attendee $249

 

Structuring and Conducting Risk-Based Internal cGMP Compliance Audits

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 701432

This training will evaluate the chief areas of an FDA cGMP compliance audit and help you understand the actual and anticipated changes in emphasis based on this new regulatory climate. It will prepare you and your company for tougher US FDA cGMP compliance audits.

Recording Available

* Per Attendee $299

 

Powerful Closed-loop CAPA - Meeting FDA Expectations

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 702012

This 90-minute webinar will show how you can implement a closed-loop CAPA system that meets CGMP requirements and U.S. FDA expectations. You will learn simple, but powerful, tools and methods that you can use regularly and systematically to define and resolve root causes, not just symptoms.

Recording Available

* Per Attendee $299

 

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