ComplianceOnline

Medical Device Regulatory Compliance Training - Live Webinars, Recordings & CDs

CGMP controlled Raw Materials
5
/ Mar
Thursday-2020

CGMP controlled Raw Materials

  • Speaker: Charity Ogunsanya
  • Product ID: 705148
  • Duration: 90 Min
This webinar will help the attendee gain an understanding of the appropriate way to design the processing of all cGMP Controlled raw materials that are used for the manufacturing of drug product. The scope of this webinar applies to all cGMP controlled raw materials that are received, requiring testing, release and issuance of specifications. It also applies to the processing of changes and retiring of previously issued controlled raw materials specification within the product manufacturing process. cGMP Raw materials that are used for product manufacturing has to be released for use in the production process. Guidance will be given as to the steps that every drug product manufacturer should follow in order to process all incoming cGMP controlled raw materials which includes the release for use in the manufacturing of products.
* Per Attendee
$249
Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities
6
/ Mar
Friday-2020

Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

  • Speaker: Vanessa Lopez
  • Product ID: 704758
  • Duration: 90 Min
This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.
* Per Attendee
$249
Introduction to Root Cause Investigation for CAPA
10
/ Mar
Tuesday-2020

Introduction to Root Cause Investigation for CAPA

  • Speaker: Vanessa Lopez
  • Product ID: 704409
  • Duration: 60 Min
This CAPA training program will provide an understanding of FDA and ISO requirements, steps in CAPA process and the challenges associated to root cause analysis. Attendees will learn the tools and quality data sources to use during root cause analysis investigation.
* Per Attendee
$229
Process Capability Analysis, and What to Do if it's Not a Bell Curve
11
/ Mar
Wednesday-2020

Process Capability Analysis, and What to Do if it's Not a Bell Curve

  • Speaker: William Levinson
  • Product ID: 705157
  • Duration: 60 Min
This process capability analysis webinar will discuss the relationship between variation and accuracy, and process yield, short term versus long term variation, non-normal distributions and how to perform a process capability study.
* Per Attendee
$199
Using Kanban JIT Systems to Run a Startup Plant
18
/ Mar
Wednesday-2020

Using Kanban JIT Systems to Run a Startup Plant

  • Speaker: Jose Mora
  • Product ID: 700419
  • Duration: 90 Min
Attend this webinar to learn how to set up and use kanbans, JIT, pull system, and drum-buffer-rope in medical device and biotechnology manufacturing start-up operations. Also attendees will learn elements of lean documents and lean configuration, sterilization lot size, MRP II kanban system and how to use kanbans to track off-site sterilization and external supply chain suppliers.
* Per Attendee
$249
How to write SOP's that Avoid Human Error
19
/ Mar
Thursday-2020

How to write SOP's that Avoid Human Error

  • Speaker: Ginette M Collazo
  • Product ID: 704418
  • Duration: 90 Min
This training program will address the common human errors and deviations related to the use of procedures. It will also offer best practices for writing SOP’s to reduce the likelihood of human errors.
* Per Attendee
$249
Making Data Driven Decisions using Statistical Hypothesis Testing
19
/ Mar
Thursday-2020

Making Data Driven Decisions using Statistical Hypothesis Testing

  • Speaker: Steven Wachs
  • Product ID: 704211
  • Duration: 60 Min
This training program will cover statistical hypothesis testing concepts including: null and alternate hypotheses, test statistics, p-values, confidence intervals, confidence levels, power, power curves, and sample sizes. Several types of hypothesis tests will be covered such as 1 and 2-sample means tests, tests of variances, and tests of proportions. Equivalence tests will also be discussed. The importance of selecting appropriate sample sizes will be stressed.
* Per Attendee
$229
Process Validation - Overview of Why and How
25
/ Mar
Wednesday-2020

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.
* Per Attendee
$199
Sterilization of Pharmaceutical Products and Medical Devices
27
/ Mar
Friday-2020

Sterilization of Pharmaceutical Products and Medical Devices

  • Speaker: Carl Patterson
  • Product ID: 705310
  • Duration: 60 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.
* Per Attendee
$229
How to Prepare a Standard Operating Procedure (SOP)?
27
/ Mar
Friday-2020

How to Prepare a Standard Operating Procedure (SOP)?

  • Speaker: Dr. Afsaneh Motamed Khorasani
  • Product ID: 705131
  • Duration: 60 Min
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.
* Per Attendee
$229
Root Cause Analysis - Getting to the Bottom of It
31
/ Mar
Tuesday-2020

Root Cause Analysis - Getting to the Bottom of It

  • Speaker: John E Lincoln
  • Product ID: 701373
  • Duration: 60 Min
This failure investigation and root cause analysis training will present a repeatable methodology / defined systems, and simple tools that you can use to trace problems to their source and root cause. Attendees will get knowledge on Flow charts, Cause and Effect Diagrams, the 5 Whys, and other statistical tools to accomplish FI/RCA.
* Per Attendee
$229
Product Stability Testing Program - Designing and Sustaining New and Existing Programs
9
/ Apr
Thursday-2020

Product Stability Testing Program - Designing and Sustaining New and Existing Programs

  • Speaker: Charity Ogunsanya
  • Product ID: 703000
  • Duration: 90 Min
This life science product stability testing webinar will explain, in detail, the requirements of the FDA’s drug stability guidelines that are stipulated for drug products and how to design a product stability testing plan that can be applied to new or modified products in the pharmaceutical, biotechnology and medical device industries.
* Per Attendee
$249
Root Cause Analysis - The Heart of Corrective Action
23
/ Apr
Thursday-2020

Root Cause Analysis - The Heart of Corrective Action

  • Speaker: Betty Lane
  • Product ID: 703391
  • Duration: 75 Min
This webinar will discuss how root cause is an essential part of a corrective action system and will provide some examples of how to perform root cause analysis.
* Per Attendee
$229
Hazard Analysis and Risk Management under ISO 14971:2007/2012
28
/ Apr
Tuesday-2020

Hazard Analysis and Risk Management under ISO 14971:2007/2012

  • Speaker: John E Lincoln
  • Product ID: 701693
  • Duration: 60 Min
In this webinar attendees will learn how to develop, use and document Hazard Analysis and the Product Risk Management File and Report per ISO 14971:2007/12 and ICH Q9. Also a field-tested (US FDA and EU Notified Body) multi-industry “model” will be presented in detail.
* Per Attendee
$229
Human Error and Cognitive Load: How to Reduce Memory and Attention Failures
12
/ May
Tuesday-2020

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

  • Speaker: Ginette M Collazo
  • Product ID: 704210
  • Duration: 60 Min
This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.
* Per Attendee
$229
Recorded/CD
Bullet-Proof CAPA

Bullet-Proof CAPA

  • Speaker: John E Lincoln
  • Product ID: 700818
  • Duration: 60 Min
In this CAPA training program attendees will learn how compliant CAPA require specific failure investigations, and are dependent upon timely and accurate determination of root cause(s) such as Correction, Corrective Action, Impact Analysis, and Preventive Actions required to meet regulatory expectations.
CD/Recorded
$299
Recorded/CD
How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

How to Achieve a Compliant and Effective Cleanroom Design and Facility Validation

  • Speaker: Charity Ogunsanya
  • Product ID: 703875
  • Duration: 90 Min
This training program will discuss designing an effective cleanroom facility validation protocol and report, when and how to transition into the routine environmental monitoring processes, how to maintain a state of control within the cleanroom, and the routine environmental monitoring and excursion investigation processes.
CD/Recorded
$299
Recorded/CD
Japan: Regulatory Compliance Requirements for Life Science Products

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.
CD/Recorded
$299
Recorded/CD
Latin America: Understanding Regulatory Compliance Requirements Across the Life Science Industry

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.
CD/Recorded
$299
Recorded/CD
Human Error Investigations, Root Cause Determination and CAPA Effectiveness

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.
CD/Recorded
$299
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