ComplianceOnline
FDA Internal Complaint Handling
23
/ Aug
Friday-2019

FDA Internal Complaint Handling

  • Speaker: Kelly Thomas
  • Product ID: 706131
  • Duration: 90 Min
Join this webinar to learn approaches to setting up an internal complaint-handling system that ensures compliance with all GMP requirements.
* Per Attendee
$249
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
Writing Effective SOPs for the Medical Device and Pharmaceutical Industries
27
/ Aug
Tuesday-2019

Writing Effective SOPs for the Medical Device and Pharmaceutical Industries

  • Speaker: Carl Patterson
  • Product ID: 706162
  • Duration: 60 Min
This webinar will help you to write clear, concise, and flexible SOPs. You will learn techniques for creating easy to read and clear SOPs your employees can easily follow. Well written SOPs ensure that your employees understand and consistently follow your manufacturing processes.
* Per Attendee
$229
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
Specification and OOS for Pharma, Biopharma and Combination Products
28
/ Aug
Wednesday-2019

Specification and OOS for Pharma, Biopharma and Combination Products

  • Speaker: Tanvir Mahmud
  • Product ID: 706078
  • Duration: 90 Min
This webinar will provide an overview of setting and maintaining specifications for Pharmaceutical and Biotechnology derived drug products throughout its shelf-life.
* Per Attendee
$249
Pharmaceutical Water System: Design, Testing and Data Management
29
/ Aug
Thursday-2019

Pharmaceutical Water System: Design, Testing and Data Management

  • Speaker: Charity Ogunsanya
  • Product ID: 705863
  • Duration: 90 Min
In this pharmaceutical water system webinar attendees will learn how to design, validate and maintain the new and existing water systems used in drug product manufacturing process. Different types of routine tests, testing frequencies, actions in each tests and sampling procedures associated with pharmaceutical water systems will be discussed to avoid any water systems failures.
* Per Attendee
$249
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
How To Implement An Effective Human Error Reduction Program
10
/ Sep
Tuesday-2019

How To Implement An Effective Human Error Reduction Program

  • Speaker: Ginette M Collazo
  • Product ID: 706156
  • Duration: 90 Min
Attend this training to learn how to implement a Human Error Reduction Program at your site. It includes practical tools and explains how to measure effectiveness to continuously improve human reliability at your site.
* Per Attendee
$249
Transfer of Analytical Methods according to USP <1224>
11
/ Sep
Wednesday-2019

Transfer of Analytical Methods according to USP <1224>

  • Speaker: Mark Powell
  • Product ID: 706036
  • Duration: 60 Min
In this analytical method transfer webinar attendees will learn the options available for the transfer of validated, non-compendial methods to a different site. In addition to current regulatory guidance, the different options for method transfer will be discussed. The webinar will set out an efficient, risk-based approach that reduces effort whilst meeting the requirements of regulators.
* 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
Pharmaceutical Data Integrity
13
/ Sep
Friday-2019

Pharmaceutical Data Integrity

  • Speaker: Mark Powell
  • Product ID: 706101
  • Duration: 60 Min
Data integrity has been the subject of increasing scrutiny during pharmaceutical regulatory inspections in recent years. Chromatographic data systems have received particular attention because of the potential for data manipulation to produce fraudulent data or uncontrolled changes in processing parameters that compromise the comparability of results between runs. This webinar explains the intention behind data integrity regulations, sets out current expectations and suggests an approach to compliance based on sound science.
* Per Attendee
$229
Steam Sterilization Microbiology and Autoclave Performance Qualification
16
/ Sep
Monday-2019

Steam Sterilization Microbiology and Autoclave Performance Qualification

  • Speaker: Danielle DeLucy
  • Product ID: 705027
  • Duration: 60 Min
In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.
* Per Attendee
$229
Comparability Protocols For Approved Drugs
17
/ Sep
Tuesday-2019

Comparability Protocols For Approved Drugs

  • Speaker: Peggy Berry
  • Product ID: 706102
  • Duration: 90 Min
This webinar will address approaches to developing comparability protocols, including primary content considerations and timing of submission. The information obtained will enable completion of appropriate testing to make changes to the drug substance or drug product formulation, manufacturing facility, and container closure which can be designed to save time and money in the future.
* Per Attendee
$249
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
Regulatory and Testing Requirements of Bacterial Endotoxin Testing (BET) using LAL
19
/ Sep
Thursday-2019

Regulatory and Testing Requirements of Bacterial Endotoxin Testing (BET) using LAL

  • Speaker: Carl Patterson
  • Product ID: 706168
  • Duration: 60 Min
cGMP drug products rely on the bacterial endotoxin test as a critical release test for products based on the route of administration of the drug product. Having a good concept of this critical release assay, its application and importance to the manufacture of cGMP product is valuable as to avoid costly errors, batch disposal, expensive failure investigations and delays in the release of products that some manufacturers have undergone.
* 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
Pharmacokinetic Principles in Preclinical Safety Assessment

Pharmacokinetic Principles in Preclinical Safety Assessment

  • Speaker: Bryan Norman
  • Product ID: 706141
  • Duration: 90 Min
This webinar will describe the basic principles of pharmacokinetics, with specific emphasis on issues that can impact toxicokinetics in preclinical safety assessment studies. It will highlight methods for the optimization of physicochemical properties in the discovery and development of oral drug candidates and explore some of the preclinical methods used to select first in human (FIH) doses.
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
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
Recorded/CD
CGMP controlled Raw Materials

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.
CD/Recorded
$299
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