ComplianceOnline
Estimating Reliability Performance with Accelerated Life Tests
23
/ Apr
Tuesday-2019

Estimating Reliability Performance with Accelerated Life Tests

  • Speaker: Steven Wachs
  • Product ID: 702095
  • Duration: 75 Min
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.
* Per Attendee
$229
Creating a Risk-based Supplier Management program
24
/ Apr
Wednesday-2019

Creating a Risk-based Supplier Management program

  • Speaker: Betty Lane
  • Product ID: 702501
  • Duration: 75 Min
This webinar on supplier controls will provide you the information you need to assure your supplier management program is in compliance with the latest FDA, European and international guidelines requiring a risk-based supplier management program. We will look at how to improve your supplier management system to meet both the FDA and ISO expectation while potentially reducing your cost of compliance.
* Per Attendee
$229
CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps
24
/ Apr
Wednesday-2019

CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps

  • Speaker: Sunil Gupta
  • Product ID: 704302
  • Duration: 90 Min
This training program will assist anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this training. Effective and practical solutions to address real-world issues will be detailed.
* Per Attendee
$249
Human Error Investigations, Root Cause Determination and CAPA Effectiveness
25
/ Apr
Thursday-2019

Human Error Investigations, Root Cause Determination and CAPA Effectiveness

  • Speaker: Ginette M Collazo
  • Product ID: 704314
  • Duration: 90 Min
This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.
* Per Attendee
$249
Good Documentation Guideline (Chapter <1029> USP)
26
/ Apr
Friday-2019

Good Documentation Guideline (Chapter <1029> USP)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705130
  • Duration: 60 Min
This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.
* Per Attendee
$229
Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device
2
/ May
Thursday-2019

Scrutinizing Test Method Validation (TMV) to Verify the Performance of a Medical Device

  • Speaker: Jose Mora
  • Product ID: 705692
  • Duration: 90 Min
* Per Attendee
$199
Effective Records Management and Document Control for Medical Devices
7
/ May
Tuesday-2019

Effective Records Management and Document Control for Medical Devices

  • Speaker: Denise Wrestler
  • Product ID: 705994
  • Duration: 60 Min
In this webinar attendees will learn the QSR and ISO 13485 requirements for document control and the ideas associated with the development and control of quality documentation. Also attendees will get knowledge on methods and practices that will improve the clarity and control of your document control system. Effective GMP documentation practices will be reviewed to ensure your paperwork is clear, complete, and easy to understand.
* Per Attendee
$229
Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements
7
/ May
Tuesday-2019

Design History Files and Technical Files/Design Dossiers - Meeting U.S. FDA CGMPS and the EU's MDD Requirements

  • Speaker: John E Lincoln
  • Product ID: 701898
  • Duration: 90 Min
This 90-minute webinar will examine in detail the U.S. FDA and EU MDD requirements for DHFs, DMRs, DHRs, and TF/DDs - their formats, content, and their commonalities, differences, interrelationships, and similarities.
* Per Attendee
$199
Production and Process Controls - Ensuring your medical device conforms to its specifications
8
/ May
Wednesday-2019

Production and Process Controls - Ensuring your medical device conforms to its specifications

  • Speaker: Denise Wrestler
  • Product ID: 706028
  • Duration: 90 Min
This presentation will cover the FDA regulations (21 CFR Subpart G Section 820.70) regarding production and process controls and how each requirement listed within the regulation can be addressed. We’ll go over examples of documentation you can use to fulfill the requirements of this section, as well as tips and tricks to what FDA auditors will look for when they come to visit your site. We will also go over some additional tips and tricks on how to convey the importance of maintaining production and process control within your organization and ensure resources are provided to meet process needs. At the end of the presentation, I will answer any questions or concerns you may have regarding FDA requirements.
* Per Attendee
$249
Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry
21
/ May
Tuesday-2019

Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry

  • Speaker: Robert J Russell
  • Product ID: 702038
  • Duration: 90 Min
The Latin America Regulatory compliance requirement training/webinar will cover topics across the full Life-Cycle of Company & Product licensing in the key markets of Latin America [Brazil, Mexico, Argentina]. Written Regulations vs. Skillful Negotiation will be explained across every critical topic. The importance of local resources, Agency meetings and knowing how to navigate the regulatory landscape will accelerate country establishment and successful product licensing.
* Per Attendee
$249
Ethylene Oxide (EO) Sterilization Basics for R&D Engineers
21
/ May
Tuesday-2019

Ethylene Oxide (EO) Sterilization Basics for R&D Engineers

  • Speaker: Gerry O Dell
  • Product ID: 701272
  • Duration: 90 Min
This Sterilization training will provide valuable information to companies that design products for terminal sterilization with ethylene oxide.
* Per Attendee
$249
Supplier Quality Assurance Agreements: Why a General Supply Agreement May Not Be Enough with Some Suppliers
22
/ May
Wednesday-2019

Supplier Quality Assurance Agreements: Why a General Supply Agreement May Not Be Enough with Some Suppliers

  • Speaker: Betty Lane
  • Product ID: 702502
  • Duration: 75 Min
This webinar will provide you the information you need to create supplier quality agreements (QA Agreements) with key suppliers and to understand which of your suppliers should have these agreements to meet expectations of the FDA and ISO 13485 Notified Body auditors.
* Per Attendee
$199
Secure Medical Device Procurement
23
/ May
Thursday-2019

Secure Medical Device Procurement

  • Speaker: Nick Sikorski,Phil Englert
  • Product ID: 706003
  • Duration: 60 Min
This Medical Device Security webinar will focus on industry leading practices to assist healthcare delivery organizations (HDOs) with the integration of security into medical device procurement to inform procurement decisions, contractual requirements, and compensating controls. Also attendees will learn the required steps involved in the procurement process, some of which include vendor-level and product-level assessments, contractual requirements, and publicly available resources to assist with standardization.
* Per Attendee
$229
Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs
23
/ May
Thursday-2019

Medical Devices: EU Directives, Guidance Documents, CE Marking Process and ISO Certification Programs

  • Speaker: Robert J Russell
  • Product ID: 701369
  • Duration: 90 Min
This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.
* Per Attendee
$199
Medical Device Software per IEC 62304
29
/ May
Wednesday-2019

Medical Device Software per IEC 62304

  • Speaker: Jose Mora
  • Product ID: 706057
  • Duration: 60 Min
You may find out after seven or more months of waiting that the 510K has been denied because the software portion of the submittal is inadequate and not compliant. Don’t let that happen. This webinar will teach you how to submit compliant and adequate software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. Also, learn how to avoid the potential audit risk which might prevent you from selling the approved product if you have been found to not have an IEC62304 Compliant Software Quality System.
* Per Attendee
$229
Recorded/CD
Better Risk-Management Alternatives to AQL Sampling Plans in Incoming QC Inspection

Better Risk-Management Alternatives to AQL Sampling Plans in Incoming QC Inspection

  • Speaker: John N Zorich
  • Product ID: 706022
  • Duration: 90 Min
Attend this webinar to learn the serious disadvantages of basing incoming QC inspection on AQL sampling plans (e.g., ANSI Z1.4 or Squeglia's C=0). You will also learn several better risk management alternatives that provide much better quality control and risk management.
Recorded/CD
New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products

New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products

  • Speaker: Angela Bazigos
  • Product ID: 704529
  • Duration: 90 Min
This training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.
CD/Recorded
$249
Recorded/CD
Software Validation and its 11 Key Documents

Software Validation and its 11 Key Documents

  • Speaker: John E Lincoln
  • Product ID: 703097
  • Duration: 90 Min
This webinar focuses on the verification and validation planning and execution of software, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions) will be evaluated, implemented, with V&V documentation and test case examples. Also attendees will learn the most recent issues the FDA has had in this area, and remediation approaches.
CD/Recorded
$299
Recorded/CD
Complaint Management: Best Practices to Assure Compliance and Customer Retention

Complaint Management: Best Practices to Assure Compliance and Customer Retention

  • Speaker: Jeff Kasoff
  • Product ID: 700986
  • Duration: 60 Min
This training will detail how you can handle customer complaints in compliance with FDA and ISO regulations. The instructor will discuss topics like best practices for documenting customer feedback, what constitutes a complaint, what to do with non-complaint feedback, and how to include complaint trending into your firm’s CAPA program.
CD/Recorded
$299
Recorded/CD
Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements

Reprocessing Reusable Medical Devices - Cleaning and Labeling Requirements

  • Speaker: John Chapman
  • Product ID: 700831
  • Duration: 60 Min
This training program will explain the rationale, the legal requirements and some methods commonly used for reprocessing and validating reusable medical devices.
CD/Recorded
$299
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