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Home › Online Training ›  Pharmaceutical Training

Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

Sub Categories: GXP Pharmaceutical | Drug Marketing Compliance | Quality and Safety | Audits & Inspections | Crisis Management | Supply Chain and Manufacturing | Cosmetics | Drug Development | Regulations & Guidances | Documentation and Data Management
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Understanding and Implementing a Quality by Design (QbD) Program
22
/ Jan
Wednesday-2020

Understanding and Implementing a Quality by Design (QbD) Program

  • Speaker: Steven Laurenz
  • Product ID: 705001
  • Duration: 60 Min
This webinar will help you understand Quality by Design (QbD) principles used in pharmaceutical product manufacturing, outline the key steps to implement a QbD program and discuss the tools used to implement a QbD approach.
* Per Attendee
$229
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Good Documentation Guideline (Chapter <1029> USP)
22
/ Jan
Wednesday-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
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Understanding the FDA Compounding Pharmacies Guidance
24
/ Jan
Friday-2020

Understanding the FDA Compounding Pharmacies Guidance

  • Speaker: Carl Patterson
  • Product ID: 705348
  • Duration: 60 Min
This webinar will cover in detail the FDA Compounding Pharmacies Guidance and will review the Aseptic Guidance document. It will help Compounding Pharmacies understand what actions are needed in order to prevent insanitary conditions.
* Per Attendee
$179
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Analytical Method Validation Under Good Laboratory Practices (GLPs)
28
/ Jan
Tuesday-2020

Analytical Method Validation Under Good Laboratory Practices (GLPs)

  • Speaker: John Fetzer
  • Product ID: 703561
  • Duration: 60 Min
This laboratory compliance training will teach you how to validate an analytical method under the GLP requirements. It will cover in detail the criteria for the validation of an analytical method including statistical and documentation requirements.
* Per Attendee
$199
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Finding and evaluating branded and generic biopharmaceutical market entry opportunities
30
/ Jan
Thursday-2020

Finding and evaluating branded and generic biopharmaceutical market entry opportunities

  • Speaker: Yali Friedman
  • Product ID: 706331
  • Duration: 120 Min
This webinar distills learnings from more than 20 years spend providing guidance to biopharmaceutical companies and related stakeholders. You will learn how to find and evaluate branded and generic entry opportunities, how to anticipate changes in demand for drugs, and how to add value to your partnerships.
* Per Attendee
$299
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Validation Sampling Plans
31
/ Jan
Friday-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
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Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes
3
/ Feb
Monday-2020

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
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Human Error Investigations, Root Cause Determination and CAPA Effectiveness
4
/ Feb
Tuesday-2020

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
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Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities
5
/ Feb
Wednesday-2020

Complaint Handling Requirements (US); Interrelationship with CAPA, Change Control, Adverse Event Reporting, Recalls and Life Cycle Process Activities

  • Speaker: Vanessa Lopez
  • Product ID: 704758
  • Duration: 90 Min
This training program will provide the regulatory requirements (US) for complaint handling in the medical device and pharmaceutical industries. The course will touch on complaint sources, and details will be furnished on the interrelationships regarding complaint handling/change control/adverse event reporting/and recalls. The course will also include timeline requirements associated to adverse event reporting, which reporting formats to use, when to recall and types of recalls.
* Per Attendee
$249
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Pharmaceutical Compressed Air - Quality GMP Standards and Requirements
6
/ Feb
Thursday-2020

Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

  • Speaker: Roger Cowan
  • Product ID: 703590
  • Duration: 60 Min
This webinar will take you through the primary sources of compressed air contamination. It will also detail GMP standards and requirements pertaining to compressed air quality.
* Per Attendee
$199
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Annex 1 and its Comparison to Compendial mandates: What does it all imply to the industry
11
/ Feb
Tuesday-2020

Annex 1 and its Comparison to Compendial mandates: What does it all 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
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Transfer of Analytical Methods according to USP <1224>
11
/ Feb
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
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Understanding and avoiding safety risks associated with Toxicophores and Structure Alerts
13
/ Feb
Thursday-2020

Understanding and avoiding safety risks associated with Toxicophores and Structure Alerts

  • Speaker: Bryan Norman
  • Product ID: 706327
  • Duration: 60 Min
Structure Alerts, also known as toxicophores, are classes of chemicals, functional groups or substructures that, when present in drugs or drug candidates, have been linked to preclinical toxicity and/or adverse drug reactions in humans. This webinar will define and describe many of those structure alerts and outline the mechanisms that have been associated with their toxicity. Mitigation strategies will also be discussed.
* Per Attendee
$229
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How to Conduct Annual Product Reviews to Achieve GMP Compliance Annual
14
/ Feb
Friday-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
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Valid Statistical Rationales for Sample Sizes used in Non-Clinical Verification, Validation, and Engineering Studies
18
/ Feb
Tuesday-2020

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.
* Per Attendee
$249
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Recorded/CD
Making Data Driven Decisions using Statistical Hypothesis Testing

Making Data Driven Decisions using Statistical Hypothesis Testing

  • Speaker: Steven Wachs
  • Product ID: 704211
  • Duration:
This training program will cover statistical hypothesis testing concepts including: null and alternate hypotheses, test statistics, p-values, confidence intervals, confidence levels, power, power curves, and sample sizes. Several types of hypothesis tests will be covered such as 1 and 2-sample means tests, tests of variances, and tests of proportions. Equivalence tests will also be discussed. The importance of selecting appropriate sample sizes will be stressed.
CD/Recorded
$299
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Recorded/CD
Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

Human Error and Cognitive Load: How to Reduce Memory and Attention Failures

  • Speaker: Ginette M Collazo
  • Product ID: 704210
  • Duration: 60 Min
This training program will discuss the types of human error, the taxonomy of human error, human error reduction initiatives, individual performance, cognitive load and human error, cognitive load categories, and more.
CD/Recorded
$299
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Recorded/CD
Pharmaceutical Water System: Design, Testing and Data Management

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.
CD/Recorded
$299
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Recorded/CD
4-Hr Virtual Training: How to Respond to an FDA Investigation

4-Hr Virtual Training: How to Respond to an FDA Investigation

  • Speaker: Joy McElroy
  • Product ID: 704549
  • Duration: 4 hrs
This FDA investigation training program will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by the FDA and define processes for preparing for FDA audits.
CD/Recorded
$449
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Recorded/CD
Principles of Drug Metabolism

Principles of Drug Metabolism

  • Speaker: Bryan Norman
  • Product ID: 706323
  • Duration: 60 Min
This webinar will describe the basic principles of drug metabolism, with specific emphasis on the various metabolic pathways and mechanisms that commonly reduce drug exposure. With greater understanding of these mechanisms, drug hunters have a higher probability of designing drug candidates that are less susceptible to metabolic clearance and elimination. The webinar will also highlight drug metabolism issues such as reactive metabolites and drug-drug interactions (DDIs) due to inhibition or activation of cytochrome P450 (CYP) enzymes. Common mitigation strategies for metabolism-related issues will also be reviewed.
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