ComplianceOnline

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

Japan: Regulatory Compliance Requirements for Life Science Products
23
/ Aug
Friday-2019

Japan: Regulatory Compliance Requirements for Life Science Products

  • Speaker: Robert J Russell
  • Product ID: 702979
  • Duration: 90 Min
This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.
* Per Attendee
$249
Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies
27
/ Aug
Tuesday-2019

Getting to Know FDA Audit Practices and the 10 Most Common Cited GMP Deficiencies

  • Speaker: Kenneth Christie
  • Product ID: 703635
  • Duration: 90 Min
This training program will provide attendees with a better understanding of how the FDA conducts their audits and the areas of most focus. In addition, it provides a summary of common GMP deficiencies given to drug manufacturers, to use to evaluate one’s own practices. Finally, when given a regulatory audit finding, this webinar will review the top five items to remember when submitting your responses to them to avoid further questions.
* Per Attendee
$249
ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements?
28
/ Aug
Wednesday-2019

ISO 14971:2012 - Does your current Risk Analysis still comply with your CE Mark requirements?

  • Speaker: Betty Lane
  • Product ID: 702871
  • Duration: 60 Min
This webinar will benefit medical device companies planning to have a CE mark under the European Union Directive 93/42/EEC. We will discuss what is new in ISO 14971:2012 and help you avoid delays in obtaining or maintaining your CE mark for compliance to the Medical device Directive, EU Directive 93/42/EEC on Medical Devices.
* Per Attendee
$229
How To Establish an Effective Chief Compliance Officer's (CCO) or Chief Risk Officer's (CRO) Function - Organization and Responsibilities
29
/ Aug
Thursday-2019

How To Establish an Effective Chief Compliance Officer's (CCO) or Chief Risk Officer's (CRO) Function - Organization and Responsibilities

  • Speaker: Javier Kuong
  • Product ID: 700095
  • Duration: 120 Min
This training will provide valuable knowledge on what companies need to do to establish an "effective" Compliance Office that leads to conceiving, developing and implementing successful GRC programs and provides top level coordinating leadership for governance, risk management and compliance issues across the enterprise.
* Per Attendee
$199
Proper Execution of Annual Product Reviews
5
/ Sep
Thursday-2019

Proper Execution of Annual Product Reviews

  • Speaker: Danielle DeLucy
  • Product ID: 704993
  • Duration: 60 Min
This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe.
* Per Attendee
$229
Failure Mode Effects Analysis
10
/ Sep
Tuesday-2019

Failure Mode Effects Analysis

  • Speaker: Michael Abitz
  • Product ID: 705333
  • Duration: 60 Min
This webinar will explain how to create Failure Mode Effects Analysis (FMEA) by combining Effective Information Collection (EIC), Process Reliability Modeling (PRM) and Failure Mode Effect Criticality Analysis (FMECA). It will also cover the methods for determining root causes of process problems and effective tools for repair of ineffective processes.
* Per Attendee
$229
Avoid Documentation 'Time Bombs'
11
/ Sep
Wednesday-2019

Avoid Documentation 'Time Bombs'

  • Speaker: John E Lincoln
  • Product ID: 701407
  • Duration: 60 Min
This documentation training will explain regulatory ramification of communication done through Lab books, SOPs, DHF, technical files etc and how to reduce it.
* Per Attendee
$229
Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes
12
/ Sep
Thursday-2019

Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes

  • Speaker: Charity Ogunsanya
  • Product ID: 703885
  • Duration: 90 Min
This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.
* Per Attendee
$249
Predicting Product Lifetimes Using Reliability Analysis Methods
13
/ Sep
Friday-2019

Predicting Product Lifetimes Using Reliability Analysis Methods

  • Speaker: Steven Wachs
  • Product ID: 702096
  • Duration: 90 Min
In this training program, participants will gain awareness of the overall methodology for setting reliability targets, estimating product reliability from test data and/or field data, and determining whether or not reliability targets are achieved. Participants will also learn how to calculate sample sizes for reliability testing.
* Per Attendee
$199
How to Investigate Environmental Monitoring Excursions
17
/ Sep
Tuesday-2019

How to Investigate Environmental Monitoring Excursions

  • Speaker: Gerry O Dell
  • Product ID: 701354
  • Duration: 90 Min
This OOS investigation training will review the various items that should be included in the investigation to determine the cause of the limit excursion for both viable and non-viable excursions.
* Per Attendee
$199
Project Management for FDA-Regulated Companies
18
/ Sep
Wednesday-2019

Project Management for FDA-Regulated Companies

  • Speaker: John E Lincoln
  • Product ID: 701758
  • Duration: 60 Min
This project management training for FDA regulated companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. It will focus on proven tools and techniques for successful development and implementation of project management planning.
* Per Attendee
$229
Good Documentation Practice and Record Keeping Regulations (FDA & EMA)
19
/ Sep
Thursday-2019

Good Documentation Practice and Record Keeping Regulations (FDA & EMA)

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705583
  • Duration: 60 Min
In this webinar, we will discuss the definition, purpose, importance of GDP, General rules of GDP, GDP as it applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029>, and introduction “Good Documentation Guidelines”. We will also briefly introduce you to the European Union (EU) GDP, and its enforcement along with some observation samples from FDA.
* Per Attendee
$229
Hypothesis Testing, P-values and Inference: When Thinking like a Statistician Makes Sense
20
/ Sep
Friday-2019

Hypothesis Testing, P-values and Inference: When Thinking like a Statistician Makes Sense

  • Speaker: Elaine Eisenbeisz
  • Product ID: 703552
  • Duration: 120 Min
This clinical research webinar will explore the reasoning that formulates null hypotheses and turns researchers’ hair gray. Attendees will learn the why and how of the scientific method and how to view the world with a statistician’s eyes. Also attendees will learn the possibilities and limitations of research questions and hypothesis development, how to interpret statistical findings with p-values, effect sizes, and confidence intervals.
* Per Attendee
$299
FDA's Ambitious Regulation of Social Media
24
/ Sep
Tuesday-2019

FDA's Ambitious Regulation of Social Media

  • Speaker: Casper Uldriks
  • Product ID: 703853
  • Duration: 60 Min
FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.
* Per Attendee
$229
Estimating Reliability Performance with Accelerated Life Tests
1
/ Oct
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
Recorded/CD
CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE

CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE

  • Speaker: Sunil Gupta
  • Product ID: 704316
  • Duration: 90 Min
This training session is intended for 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. The program will provide effective and practical solutions to address real-world issues.
CD/Recorded
$299
Recorded/CD
CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)

CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)

  • Speaker: Sunil Gupta
  • Product ID: 704313
  • Duration: 90 Min
This training program is intended for 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. Through case study analysis, the course will examine best practices to provide thoughts and ideas to develop or improve the CDISC mapping system.
CD/Recorded
$299
Recorded/CD
Process Validation - Overview of Why and How

Process Validation - Overview of Why and How

  • Speaker: Betty Lane
  • Product ID: 703520
  • Duration: 60 Min
This webinar will provide understanding of FDA and ISO 13485 requirements for process validation and how to implement them.
CD/Recorded
$249
Recorded/CD
Surviving an FDA Sponsor Inspection - Training for Success

Surviving an FDA Sponsor Inspection - Training for Success

  • Speaker: Stephen Schwartz
  • Product ID: 704516
  • Duration: 105 Min
This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.
CD/Recorded
$429
Recorded/CD
Sterilization of Pharmaceutical Products and Medical Devices

Sterilization of Pharmaceutical Products and Medical Devices

  • Speaker: Carl Patterson
  • Product ID: 705310
  • Duration: 90 Min
This webinar will discuss in detail the methods of sterilization to be used on medical devices and pharmaceutical products including advantages and disadvantages of each method. Also attendees will understand the regulations pertaining to sterilization of products that will help to decide with method to use for their product. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.
CD/Recorded
$299
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