ComplianceOnline
PAT (Process Analytical Technology): An FDA and Industry Effort
7
/ Apr
Tuesday-2020

PAT (Process Analytical Technology): An FDA and Industry Effort

  • Speaker: Nissan Cohen
  • Product ID: 706370
  • Duration: 90 Min
Process Analytical Technology was released by the FDA as a 21st century guideline in September 2004. This guidance was released to help the pharmaceutical industry with real-time release, process understanding, and using the process to ensure all CPPs and CQAs meet compliance, URS, and SOPs. The use of PAT can alleviate strenuous validation procedures by using the process as the function of validation.
* Per Attendee
$249
Transfer of Analytical Methods according to USP <1224>
7
/ Apr
Tuesday-2020

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
Pharmaceutical Data Integrity
8
/ Apr
Wednesday-2020

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
HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms
9
/ Apr
Thursday-2020

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

  • Speaker: Roger Cowan
  • Product ID: 703831
  • Duration: 60 Min
Environmental control of pharmaceutical cleanrooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination. Therefore, the design, validation and ongoing monitoring of a cleanroom HVAC system are necessary to assure the quality and safety of the pharmaceutical product. This training program will offer attendees a proper understanding of the cleanroom environment and its testing requirements according to international regulatory standards from a compliance perspective.
* 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
Handling OOS Test Results and Completing Robust Investigations
9
/ Apr
Thursday-2020

Handling OOS Test Results and Completing Robust Investigations

  • 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
Validation of HPLC/UPLC Methodologies
14
/ Apr
Tuesday-2020

Validation of HPLC/UPLC Methodologies

  • Speaker: John Fetzer
  • Product ID: 705291
  • Duration: 60 Min
This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.
* Per Attendee
$229
Overcoming Obstacles of The Canadian Drug Regulatory Landscape
15
/ Apr
Wednesday-2020

Overcoming Obstacles of The Canadian Drug Regulatory Landscape

  • Speaker: Susanne Picard
  • Product ID: 706188
  • Duration: 60 Min
The Canadian Drug Approval Process is misunderstood by many and considered harsh by some. We will explore reasons why the Canadian market should not be overlooked and the benefits of including Canada in strategic drug development initiatives. We will share insights and practical examples that facilitate a positive, proactive and transparent interaction with Health Canada, and provide strategies for avoiding obstacles and managing them efficiently should they occur.
* Per Attendee
$229
Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities
16
/ Apr
Thursday-2020

Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities

  • Speaker: Robert J Russell
  • Product ID: 701367
  • Duration: 90 Min
This DMFs (Drug Master Files) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.
* Per Attendee
$249
How To Implement An Effective Human Error Reduction Program
22
/ Apr
Wednesday-2020

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
Understanding FDA Import Alerts:  What Are They and Recommendations For Removing Your Company And Products From An Alert
23
/ Apr
Thursday-2020

Understanding FDA Import Alerts: What Are They and Recommendations For Removing Your Company And Products From An Alert

  • Speaker: Karl M. Nobert
  • Product ID: 703313
  • Duration: 90 Min
This webinar provides attendees with an introduction to FDA Import Alerts and what they are, examine why they are issued, show you where to locate them and how to determine whether a company or product is on one, and finally, provide strategic recommendations for removal from an alert.
* Per Attendee
$249
Pharmaceutical Pricing - a Global Perspective - US, EU and ASEAN
23
/ Apr
Thursday-2020

Pharmaceutical Pricing - a Global Perspective - US, EU and ASEAN

  • Speaker: Peter Wittner
  • Product ID: 706400
  • Duration: 60 Min
Prices for some products can vary from around $1,000 per pack in the US to one third of that for the certain product in South East Asia. In EU markets, prices are in between these two extremes and the same product can sell for anything between one-half and two thirds of the US price. The webinar sets out to examine these difference, explain how the price variations have arisen and aims to provide participants with some insights into ways of coping with them when moving into new markets.
* Per Attendee
$229
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
Immunogenicity Of Biological Drugs: Why, How And What
28
/ Apr
Tuesday-2020

Immunogenicity Of Biological Drugs: Why, How And What

  • Speaker: Michel Awwad
  • Product ID: 706402
  • Duration: 60 Min
The consequences of an immune response to biologicals, range from transient appearance of antibodies without any clinical significance to severe life-threatening conditions. Understanding why an immune response is generated, how to detect or predict its generation will help in designing products that will be efficacious and therapeutic.
* Per Attendee
$229
Validation Sampling Plans
28
/ Apr
Tuesday-2020

Validation Sampling Plans

  • Speaker: Alan M Golden
  • Product ID: 706332
  • Duration: 60 Min
This webinar will discuss setting up statistically justified sampling plans for process validation. Discussion will also involve using the sampling plan to set acceptance criteria for process validation. Setting acceptance criteria for test method validation will also be presented.
* Per Attendee
$229
Recorded/CD
Human Error Reduction Techniques for Floor Supervisors

Human Error Reduction Techniques for Floor Supervisors

  • Speaker: Ginette M Collazo
  • Product ID: 706137
  • Duration: 90 Min
Attend this course to gain practical approaches for supervision on the floor, strategies to get your group in sync and approach issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.
CD/Recorded
$299
Recorded/CD
FDA's Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products

FDA's Deeming Regulations for e-Cigarettes, Cigars, and other Tobacco-related Products

  • Speaker: Carolyn Troiano
  • Product ID: 705097
  • Duration: 90 Min
This webinar is intended for those working in the FDA-regulated tobacco and related industries, including e-liquids (vapor), e-cigarettes, cigars, and smokeless tobacco products. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance. You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a 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
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
How to Detect Lack of Data Integrity

How to Detect Lack of Data Integrity

  • Speaker: Ron Snee
  • Product ID: 706369
  • Duration: 90 Min
This webinar provides some practical and useful answers to the question: “How to Detect Lack of Data Integrity?” Humans, equipment or both can be the source of lack of data integrity. This session discusses both types of data integrity sources and introduces the assessment of “data pedigree” as a concept that puts focus on the types of data integrity issues and analytical and statistical methods for detecting data problems. Pharma and biotech case studies are used throughout the presentation to illustrate how the various approaches fit together.
CD/Recorded
$299
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