ComplianceOnline
ANDA Submission and GDUFA Guidance
1
/ Oct
Thursday-2020

ANDA Submission and GDUFA Guidance

  • Speaker: Charles H Paul
  • Product ID: 706538
  • Duration: 60 Min
In order to properly, effectively, and efficiently bring generic drugs and medicinal products to market, it is crucial to anyone interacting with the submittal process to understand how the process is structured and functions
* Per Attendee
$329
Implementation and Management of GMP Data Integrity
7
/ Oct
Wednesday-2020

Implementation and Management of GMP Data Integrity

  • Speaker: Danielle DeLucy
  • Product ID: 705029
  • Duration: 90 Min
Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.
* Per Attendee
$249
An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (''HCT/Ps'') including Stem Cell-Based Drug Products for Human Use
28
/ Oct
Wednesday-2020

An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (''HCT/Ps'') including Stem Cell-Based Drug Products for Human Use

  • Speaker: Karl M. Nobert
  • Product ID: 701927
  • Duration: 90 Min
This webinar will review FDA's regulatory oversight of stem cell-based products when used in humans and analyze its potential impact on the industry in the future. Learn FDA's criteria for marketing and promotion of stem cell-based products for therapeutic application.
* Per Attendee
$349
FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More
28
/ Oct
Wednesday-2020

FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More

  • Speaker: Danielle DeLucy
  • Product ID: 704659
  • Duration: 60 Min
The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.
* Per Attendee
$229
Training and Development in The Life Sciences - Build Training That Works
30
/ Oct
Friday-2020

Training and Development in The Life Sciences - Build Training That Works

  • Speaker: Charles H Paul
  • Product ID: 706542
  • Duration: 60 Min
This webinar will explore the area of training in regulated environments, its importance, and its relationship to compliance documentation. You will learn how to achieve world-class compliance, improved operational performance, improved quality, and improved employee/associate safety through training.
* Per Attendee
$329
How to Conduct Successful Supplier Audits
4
/ Nov
Wednesday-2020

How to Conduct Successful Supplier Audits

  • Speaker: Danielle DeLucy
  • Product ID: 704499
  • Duration: 60 Min
This training program will provide participants with a working knowledge of supplier audits. The why, when, who, how, and what of conducting a supplier audit will be reviewed to ensure that your supplier can meet all your expectations.
* Per Attendee
$199
Leveraging Metadata for SDTM Automation and Compliance
12
/ Nov
Thursday-2020

Leveraging Metadata for SDTM Automation and Compliance

  • Speaker: Sunil Gupta
  • Product ID: 706569
  • Duration: 90 Min
This presentation reviews the six levels of metdata level processing that all organizations need to be aware of and plan for. In the current days of automation in our daily lives at home, in the car and in various industries, FDA submissions in the pharma industry is next in line for more automation through metadata. We will explore examples for each of the metadata level. Metadata will be reviewed to understand how metadata has answers to key questions for logical processing. SAS tools will be reviewed to write code for more automation process.
* Per Attendee
$349
Properly Investigating and Remediating OOS Results
17
/ Nov
Tuesday-2020

Properly Investigating and Remediating OOS Results

  • Speaker: Danielle DeLucy
  • Product ID: 704351
  • Duration: 90 Min
This webinar will review the regulatory requirements for investigating an OOS Investigation. The responsibilities of the analyst, the supervisor and QA will be discussed. A detailed flow chart will be used to help the attendees clearly understand the steps and the order in which they are to be performed. The structure of an Investigation report which properly documents the investigation will be discussed.
* Per Attendee
$249
Recorded/CD
How to Prepare a Standard Operating Procedure (SOP)?

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.
CD/Recorded
$299
Recorded/CD
Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)

  • Speaker: Joy McElroy
  • Product ID: 704086
  • Duration: 120 Min
The objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing practices.
CD/Recorded
$349
Recorded/CD
The Drug Development Process from Concept to Market

The Drug Development Process from Concept to Market

  • Speaker: Mark Powell
  • Product ID: 706288
  • Duration: 60 Min
The goal of pharmaceutical development is to design a manufacturing process that can produce a drug product to a consistently high quality. This webinar sets out regulatory expectations for pharmaceutical development, taking account of the risk-based approach set out in ICH guidance documents (Q8, Q9, Q10 and draft Q12). It covers some examples of problems encountered during drug development.
CD/Recorded
$399
Recorded/CD
How to Conduct Annual Product Reviews to Achieve GMP Compliance Annual

How to Conduct Annual Product Reviews to Achieve GMP Compliance Annual

  • 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.
CD/Recorded
$299
Recorded/CD
Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

  • Speaker: Joy McElroy
  • Product ID: 704531
  • Duration: 120 Min
This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.
CD/Recorded
$349
Recorded/CD
Annual Current Good Manufacturing Practices (cGMP) Training

Annual Current Good Manufacturing Practices (cGMP) Training

  • Speaker: Kelly Thomas
  • Product ID: 705422
  • Duration: 60 Min
This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.
CD/Recorded
$249
Recorded/CD
Transfer of Analytical Methods according to USP <1224>

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.
CD/Recorded
$299
Recorded/CD
Steam Sterilization Microbiology and Autoclave Performance Qualification

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.
CD/Recorded
$299
Recorded/CD
Good Documentation Guideline (Chapter <1029> USP)

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.
CD/Recorded
$299
Recorded/CD
Statistical Tolerance Intervals & Limits: What, Why, How, & Alternatives

Statistical Tolerance Intervals & Limits: What, Why, How, & Alternatives

  • Speaker: John N Zorich
  • Product ID: 706349
  • Duration: 90 Min
This webinar explains the practical use and theoretical basis of Statistical Tolerance Intervals and Statistical Tolerance Limits. It explains the difference between non-statistical tolerance limits and statistical ones. It explains the difference between "identifying the distribution" and "transforming the data". You will learn how "Normal Tolerance Intervals" are calculated, and how to transform non-normal data into Normality, how to calculate Statistical Tolerance Intervals for data that cannot be transformed to Normality. And it recommends an alternative method to using Statistical Tolerance Intervals.
CD/Recorded
$299
Recorded/CD
FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control

FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control

  • Speaker: Kelly Thomas
  • Product ID: 702540
  • Duration: 60 Min
This webinar will discuss the FDA requirements and guidelines for investigating Out-of-trend (OOT) results in the pharmaceutical laboratory. It will also cover FDA compliant documentation of OOT, failure investigations, root causes and CAPA.
CD/Recorded
$299
Recorded/CD
Annex 1 Chapter 6 and its Comparison to Compendial Mandates: What Does It Imply to  the Industry

Annex 1 Chapter 6 and its Comparison to Compendial Mandates: What Does It Imply to the Industry

  • Speaker: Nissan Cohen
  • Product ID: 706362
  • Duration: 60 Min
Annex 1 is a European mandate for Sterile Products Manufacturing but encompasses many critical utilities including pharmaceutical water. The current version is under revision and may be contrary to some Pharmacopeias. Annex 1 will be enforced by PIC/S, EMEA, and other European regulators. This is a very important subject to anyone manufacturing products either in or for the European market.
CD/Recorded
$299
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