Qualification of Suppliers and Contract Manufacturing Organizations
Qualification of Suppliers and Contract Manufacturing Organizations
: Edwin Waldbusser
Recorded Webinar

Suppliers and CMO’s must be selected following a rigorous formalized procedure. This webinar will describe a compliant program based on regulatory requirements. Phases of supplier and CMO selection from initial telephone inquiry to the quality survey to qualification audit will be explained. The qualification audit will be described with key points to evaluate explained. How to deal with uncooperative suppl.....

$200.00
21 CFR Part 11 (Electronic Records/ Signatures) Compliance for Computer Systems Regulated by FDA
21 CFR Part 11 (Electronic Records/ Signatures) Compliance for Computer Systems Regulated by FDA
: Carolyn Troiano
Recorded Webinar

This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a .....

$200.00
21 CFR Part11 Compliance
21 CFR Part11 Compliance
: Edwin Waldbusser
Recorded Webinar

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records will be explained. FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants t.....

$200.00
Automating Assays for Clinical Diagnostics
Automating Assays for Clinical Diagnostics
: Todd Graham
Recorded Webinar

Laboratories need to transition technologies all of the time. From new ways to perform assays to outdated technology, to new equipment pushes to the various needs of end users, assays need to switch between technologies on a regular basis. One needs to be able to easily and robustly transition assays from one technology to another. With this seminar, you will be able to fully understand how your essay is cu.....

$200.00
CAPA: Corrective and Preventative Actions and Addressing Non-Conformances
CAPA: Corrective and Preventative Actions and Addressing Non-Conformances
: Michael Brodsky
Recorded Webinar

CAPA is both a precursor to and component of RCA that helps people prevent non-conformances from occurring and if all else fails; answer the question of why the non-conformance occurred in the first place. Root Cause Analysis (RCA) is a popular and often-used technique that helps people answer the question of why the problem. What is a non-conformance?  When you have a non-conformance in the laboratory.....

$200.00
Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA
Disaster Recovery and Business Continuity Planning for Computer Systems Regulated by FDA
: Carolyn Troiano
Recorded Webinar

FDA guidelines are very specific in terms of how computer systems are to be managed, and each company should have a specific strategy and methodology, along with a set of rigorous tactical processes and procedures that prescribe how Disaster Recovery and Business Continuity Planning should be carried out. This is necessary to protect against the onslaught of threats and attacks, both from natural disasters .....

$200.00
Functional System Requirements Planning for Computer Systems Regulated by FDA
Functional System Requirements Planning for Computer Systems Regulated by FDA
: Carolyn Troiano
Recorded Webinar

This course is intended to provide specific guidelines for coaching attendees on the best practices for developing requirements for computer systems regulated by FDA. There are several key types of requirements that will be covered, including user, functional, performance, system, environmental and other categories.The attendee will learn about the requirements for planning, executing and documenting the re.....

$200.00
Generation of Controlled Documents and Related Training
Generation of Controlled Documents and Related Training
: Jerry Dalfors
Recorded Webinar

This presentation is intended to provide the needed documentation practices associated with documentation creation, document approval, handwritten entries, copies of documents, document maintenance and document modification. This document details the minimum documentation requirements for MEDIn still personnel, contractors and consultants completing cGMP documents. Specific operational procedures using more.....

$200.00
Human Factors Validation Testing Following ISO 62366 and new FDA Guidance
Human Factors Validation Testing Following ISO 62366 and new FDA Guidance
: Edwin Waldbusser
Recorded Webinar

Following the implementation of the results of a Human Factors/ Usability study, a validation of the safety and effectiveness of the use of the device must be conducted. We will explain the FDA required the number of validation participants from each "distinct user population". We will explain how to choose the tests to be conducted and the studies that must be completed prior to the actual validation test......

$200.00
In Depth Testing of Computer Systems Regulated by FDA
In Depth Testing of Computer Systems Regulated by FDA
: Carolyn Troiano
Recorded Webinar

We will discuss the importance of applying industry best practices when performing the validation process for a computerized system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly. Testing is a very large co.....

$200.00
Legal, Regulatory and Policy Issues Related to Validation of Computer Systems Regulated by FDA
Legal, Regulatory and Policy Issues Related to Validation of Computer Systems Regulated by FDA
: Carolyn Troiano
Recorded Webinar

We will discuss the importance of applying industry best practices when performing the validation process for a computerized system used in an FDA-regulated environment (i.e., the system "touches" product during the manufacturing, testing or distribution process). Such a system must be validated in accordance with FDA guidelines for computerized systems and documented accordingly. There are legal, regulator.....

$200.00
Mathematics of Terminal Sterilization - Probability of Survival Approach -vs- Overkill Approach
Mathematics of Terminal Sterilization - Probability of Survival Approach -vs- Overkill Approach
: Jerry Dalfors
Recorded Webinar

Heat sterilization is a PROBABILITY function dependent on heat exposure, the number of microorganisms, and the heat resistance of the microorganisms. Current regulations expect the sterilization process to provide a level of assurance of at least 1 x 10-6 probability (fewer than one non-sterile unit per million units) of survival (non-sterility) for terminally sterilized parenteral and medical devices. Sinc.....

$200.00
New FDA and EMA Labeling Requirements for Regulated Industries
New FDA and EMA Labeling Requirements for Regulated Industries
: Carolyn Troiano
Recorded Webinar

This webinar will help you understand in detail the new requirements for labeling from FDA and EMA, including a set of rules for electronic submission of labeling content, and strategies and actions for meeting the new challenges posed.Pharmaceutical companies must manage the process of designing and creating product labels that meet regulatory requirements. This includes product-labeling documents such as .....

$200.00
Quality Control for Analytical Materials used in Microbiology Laboratories
Quality Control for Analytical Materials used in Microbiology Laboratories
: Michael Brodsky
Recorded Webinar

Many laboratories are unsure about which QC practices are needed and what criteria to use to assess the acceptability of the performance of analytical materials, to meet not only their requirements but also to meet the requirements of ISO/IEC 17025. During this webinar, we will discuss a practical QC approach for in-house prepared and/or commercially purchased media, test kits and reagents specifically appl.....

$200.00
The FDA Inspection: From SOP to 483
The FDA Inspection: From SOP to 483
: Jeff Kasoff
Recorded Webinar

This is a detailed course designed to provide medical device/pharmaceutical professionals with the information they require to prepare for and manage FDA inspections. This course provides the rationale, strategies and flows on how to plan for an inspection, the inspection process and approach, and which company roles should be assigned for these types of inspections, among other related topics.Learning Obje.....

$200.00
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