ComplianceOnline
Preclinical Development of Drugs with Special Emphasis on Biologicals
8
/ Jul
Wednesday-2020

Preclinical Development of Drugs with Special Emphasis on Biologicals

  • Speaker: Michel Awwad
  • Product ID: 706465
  • Duration: 60 Min
Preclinical development is a critical stage of drug development that determines as well as measures the “therapeutic” doses needed and the ability to achieve these doses. Moreover, preclinical studies assess the safety of the drug at these doses.
* Per Attendee
$229
Reviewing Drug Product Batch Records
9
/ Jul
Thursday-2020

Reviewing Drug Product Batch Records

  • Speaker: Mark Powell
  • Product ID: 706287
  • Duration: 60 Min
Batch record review is an important step in the release of a medicinal product. This webinar sets out the regulatory requirements for batch records and sets out a systematic approach for review. Trending of batch data is also discussed.
* Per Attendee
$229
Good Documentation Guideline (Chapter <1029> USP)
14
/ Jul
Tuesday-2020

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.
* Per Attendee
$229
Solving Statistical Mysteries - What Does FDA Want?
20
/ Jul
Monday-2020

Solving Statistical Mysteries - What Does FDA Want?

  • Speaker: Ron Snee
  • Product ID: 706371
  • Duration: 90 Min

This webinar provides some practical and useful answers to the question

"What Kind of Statistical Methods and Tools Does the FDA Want Pharma to Use?"

FDA’s guidances and regulations have emphasized the use of statistics for many years. Statistical thinking and methods is an integral part of the Jan 2011 FDA Process Validation Guidance. It can be argued that the FDA is looking for the pharma and biotech industries to make even greater use of statistical thinking and methods. Even with this long history, the use of statistics seems to be a source of uncertainty and anxiety for many. This presentation provides an overview of what it appears the FDA is looking for in the use statistics including examples and recommended approaches.

* Per Attendee
$249
Annex 1 Chapter 6 and its Comparison to Compendial Mandates: What Does It Imply to  the Industry
21
/ Jul
Tuesday-2020

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.
* Per Attendee
$229
Japan: Regulatory Compliance Requirements for Life Science Products
21
/ Jul
Tuesday-2020

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
FDA Compliant Handling of Out-of-Trend Results in Pharmaceutical Quality Control
28
/ Jul
Tuesday-2020

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

  • Speaker: Kelly Thomas
  • Product ID: 702540
  • Duration: 90 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.
* Per Attendee
$249
How to Conduct Annual Product Reviews to Achieve GMP Compliance Annual
28
/ Jul
Tuesday-2020

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.
* Per Attendee
$229
Steam Sterilization Microbiology and Autoclave Performance Qualification
6
/ Aug
Thursday-2020

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
Annual Current Good Manufacturing Practices (cGMP) Training
20
/ Aug
Thursday-2020

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.
* Per Attendee
$199
Labeling for Prescription Drugs, Biologics and Combination Products
3
/ Sep
Thursday-2020

Labeling for Prescription Drugs, Biologics and Combination Products

  • Speaker: Eleonora Babayants
  • Product ID: 706502
  • Duration: 60 Min
In 2019, FDA issued two guidance documents to ensure that FDA-approved labeling provides clear and complete information and to prevent the potential for abuse on how drugs or biologics are used. These guidance documents reflect the FDA’s efforts to ensure that both health care professionals and patients have up-to-date, accurate and actionable information about prescription drugs to inform treatment decisions. It is important for companies to learn these new guidance documents so that the new rules could be applied to labels creation.
* Per Attendee
$229
The Drug Development Process from Concept to Market
7
/ Sep
Monday-2020

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.
* Per Attendee
$229
How to Prepare a Standard Operating Procedure (SOP)?
15
/ Sep
Tuesday-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
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
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
Recorded/CD
Understanding the Drug Supply Chain Security Act (DSCSA)

Understanding the Drug Supply Chain Security Act (DSCSA)

  • Speaker: Eleonora Babayants
  • Product ID: 706499
  • Duration: 60 Min
As the Drug Supply Chain Security Act (DSCSA) key requirements continue to take effect, FDA has begun its enforcement. Any company involved in the sale or purchase of prescription drugs has to comply with this act. This webinar will describe the key requirements of this act, reporting requirements, and how to comply with this act.
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
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
Valid Statistical Rationales for Sample Sizes used in Non-Clinical Verification, Validation, and Engineering Studies

Valid Statistical Rationales for Sample Sizes used in Non-Clinical Verification, Validation, and Engineering Studies

  • Speaker: John N Zorich
  • Product ID: 706189
  • Duration: 90 Min
This webinar provides guidance on how to justify sample sizes, and thereby indirectly provides guidance on how to choose sample sizes. Those justifications can then be documented in Protocols or regulatory submissions or can be given to regulatory auditors who may ask for them during onsite audits at your company. Thus, this webinar is designed to help you avoid regulatory delays in product approvals and to prevent an auditor from issuing you a nonconformity.
CD/Recorded
$299
Recorded/CD
EMA Guidance during the COVID-19: Requirements for Accelerated Assessment

EMA Guidance during the COVID-19: Requirements for Accelerated Assessment

  • Speaker: Mark Powell
  • Product ID: 706487
  • Duration: 60 Min
Accelerated assessment of medicines in the EMA’s centralised procedure may be granted for treatments that are of major interest to public health. It is one of a number of regulatory mechanisms designed to provide early access to new drug treatments.
CD/Recorded
$299
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