ComplianceOnline
Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities
25
/ Apr
Thursday-2019

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
Human Error Investigations, Root Cause Determination and CAPA Effectiveness
25
/ Apr
Thursday-2019

Human Error Investigations, Root Cause Determination and CAPA Effectiveness

  • Speaker: Ginette M Collazo
  • Product ID: 704314
  • Duration: 90 Min
This training program will offer attendees an understanding of human error, its factors and causes. The program will also identify the regulatory and business importance of human error prevention and define the process to manage human error deviations.
* Per Attendee
$249
Good Documentation Guideline (Chapter <1029> USP)
26
/ Apr
Friday-2019

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
Generic markets – why they differ so much within Europe
30
/ Apr
Tuesday-2019

Generic markets – why they differ so much within Europe

  • Speaker: Peter Wittner
  • Product ID: 706049
  • Duration: 60 Min
This webinar provides insights into the European generic market, its regulatory procedures and the impact of the differing national pricing and healthcare environments that have shaped the individual country markets.
* Per Attendee
$229
Handling OOS Test Results and Completing Robust Investigations
2
/ May
Thursday-2019

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
$199
GMP Environmental Monitoring for Pharmaceutical Clean Rooms
14
/ May
Tuesday-2019

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

  • Speaker: Roger Cowan
  • Product ID: 705783
  • Duration: 60 Min
This webinar will discuss various US and international regulatory requirements, testing requirements for environmental monitoring program, current air and surface monitoring for measurement of no-viable particulate, microbial contamination, contamination due to personnel (gowning techniques and aseptic practices), ongoing monitoring practices with reference to sampling frequency, sampling locations and investigation of action level excursions and monitoring data.
* Per Attendee
$199
Auditing API Facilities: A MUST to properly prepare for an FDA Regulatory API GMP Inspection
15
/ May
Wednesday-2019

Auditing API Facilities: A MUST to properly prepare for an FDA Regulatory API GMP Inspection

  • Speaker: Max Lazar
  • Product ID: 705985
  • Duration: 60 Min
In this FDA inspection webinar attendees will learn the basic understanding of Active Pharmaceutical Ingredient Good Manufacturing Practices (ICH Q7) and the most important elements of API GMP to avoid serious deviations and failures during either a Pre-Approval or GMP Inspection.
* Per Attendee
$229
Transfer of Analytical Methods according to USP <1224>
17
/ May
Friday-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
ICH Q7 FDA Guidance – Its Structure, History, Application and Writer's Intent
23
/ May
Thursday-2019

ICH Q7 FDA Guidance – Its Structure, History, Application and Writer's Intent

  • Speaker: Max Lazar
  • Product ID: 705996
  • Duration: 60 Min
In this webinar attendees will learn the background of all sections of ICH Q7 guidance, key critical section contents, the authors intent when writing critical parts of this guidance and how to apply Q7 in an Active Pharmaceutical Ingredient (API) facility.
* Per Attendee
$229
Health Canada Regulations on NHP's vs. FDA's Dietary Supplement Regulations
28
/ May
Tuesday-2019

Health Canada Regulations on NHP's vs. FDA's Dietary Supplement Regulations

  • Speaker: Norma Skolnik
  • Product ID: 705497
  • Duration: 60 Min
This online training will offer an overview of what Health Canada considers to be a Natural Health product (NHP) and review Canadian regulatory requirements for Natural Health products. It will compare Canadian requirements with U.S. FDA requirements for marketing and labeling dietary supplements and convey an understanding of how they differ.
* Per Attendee
$229
CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps
29
/ May
Wednesday-2019

CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps

  • Speaker: Sunil Gupta
  • Product ID: 704302
  • Duration: 90 Min
This training program will assist 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. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this training. Effective and practical solutions to address real-world issues will be detailed.
* Per Attendee
$249
How to Conduct Successful Supplier Audits
30
/ May
Thursday-2019

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
How to Prepare a Standard Operating Procedure (SOP)?
31
/ May
Friday-2019

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
U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics
4
/ Jun
Tuesday-2019

U.S. Adverse Event Reporting Regulations for Drugs, Dietary Supplements and Cosmetics

  • Speaker: Norma Skolnik
  • Product ID: 704371
  • Duration: 60 Min
In order to market dietary supplements and OTC drugs in the U.S., reporting serious adverse events is required. It’s essential to understand these important FDA requirements to assure regulatory compliance and avoid an FDA warning letter or 483 audit issues.
* Per Attendee
$199
Technical Writing in the Pharmaceutical Industry
11
/ Jun
Tuesday-2019

Technical Writing in the Pharmaceutical Industry

  • Speaker: Robert Peoples
  • Product ID: 706060
  • Duration: 60 Min
In this webinar, learn how to write technical documents in a highly specialized, highly regulated field like the pharmaceutical industry. It will teach you the techniques that that are easy to understand and help in creating high quality documents with the least amount of problems.
* Per Attendee
$229
Recorded/CD
Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

  • Speaker: Roger Cowan
  • Product ID: 703727
  • Duration: 60 Min
It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.
CD/Recorded
$299
Recorded/CD
New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products

New and Expected Guidance’s on Data Standards and Electronic Submissions for Drugs and Medical Products

  • Speaker: Angela Bazigos
  • Product ID: 704529
  • Duration: 90 Min
This training program will examine the approval process for drugs, biologics and devices and elaborate FDA submission requirements and guidances. It will also discuss electronic regulatory submission and gateway for FDA and FDA eCTD guidance and specifications.
CD/Recorded
$249
Recorded/CD
Software Validation and its 11 Key Documents

Software Validation and its 11 Key Documents

  • Speaker: John E Lincoln
  • Product ID: 703097
  • Duration: 90 Min
This webinar focuses on the verification and validation planning and execution of software, after basic developmental testing and de-bug. It includes COTS (commercial off-the-shelf) and the growing field of "cloud"-based software. A suggested FDA model (mandated for submissions) will be evaluated, implemented, with V&V documentation and test case examples. Also attendees will learn the most recent issues the FDA has had in this area, and remediation approaches.
CD/Recorded
$299
Recorded/CD
How to Conduct Annual Product Reviews to Achieve GMP Compliance

How to Conduct Annual Product Reviews to Achieve GMP Compliance

  • 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
Practical Implementation of Pharmaceutical Quality Risk Management (QRM)

Practical Implementation of Pharmaceutical Quality Risk Management (QRM)

  • Speaker: Steven Laurenz
  • Product ID: 706012
  • Duration: 60 Min
In this Pharmaceutical Quality Risk Management webinar attendees will come away with the ability to recognize the purpose and value of Quality Risk Management QRM, the level of risk based on severity, occurrence, detectability and how the QRM process is used to make decisions. Also attendees will be able to identify key QRM terminology and recognize the four (4) key components of Quality Risk Management. Finally they will have a strong understanding of the key concepts associated with the risk management risk tools and their application.
CD/Recorded
$299
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