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Home › Online Training ›  Research & Development

Research and Development Training - Live Webinars, Recordings & CDs

ComplianceOnline's training programs for Research and Development professionals are designed to stimulate and manage innovation in the workplace. Improve the productivity of your R&D and foster excellence by learning concepts, methodologies, and the use of tools to strategically plan product development and to manage core competencies. Explore the courses developed by a multitude of experts for diverse, creative, intelligent, and independent R&D professionals.
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Recorded/CD
How to Properly Monitor Process and Performance of Pharmaceutical Solid Dosage Equipment

How to Properly Monitor Process and Performance of Pharmaceutical Solid Dosage Equipment

  • Speaker: Michael Levin
  • Product ID: 704274
  • Duration: 60 Min
Among other key topics, this training program will focus on what can be monitored in mixing operations, wet granulation operations, dry granulation operations, compaction operations, and coating operations.
CD/Recorded
$229
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Recorded/CD
Making Sense of BSCs, Hoods, Isolators, RABs

Making Sense of BSCs, Hoods, Isolators, RABs

  • Speaker: Joseph Winslow
  • Product ID: 704361
  • Duration: 60 Min
Attendees will come away from the training program with the tools they need to understand the various types of enclosures and how to select the correct type of enclosure for their process in order to meet regulations, protect the product, and ensure worker safety. The course is apt for personnel in FDA regulated industries who want to learn about what enclosure is best suited for their process and why.
CD/Recorded
$229
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Recorded/CD
Pharmaceutical Water Use and Monitoring

Pharmaceutical Water Use and Monitoring

  • Speaker: Igor Gorsky
  • Product ID: 704336
  • Duration: 150 Min
This training program will guide attendees on how to best deliver water from a high purity water distribution system. Attendees will learn to capitalize on the advantages of online analytical instrumentation and understand the value of rapid microbiological methods. The program will also offer an understanding of real-time release of water.
CD/Recorded
$50
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Recorded/CD
How to Survive FDA's New Inspection and Enforcement Practices

How to Survive FDA's New Inspection and Enforcement Practices

  • Speaker: Dr. Ludwig Huber
  • Product ID: 704328
  • Duration: 75 Min
This training program will enumerate the inspection process for API, drug and device manufacturers and summarize recent changes. It will guide attendees on preparing staff for the new FDA inspections and discuss the role of exit meeting to avoid enforcement.
CD/Recorded
$229
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Recorded/CD
Generic Drug Product Development (ANDA) and Paragraph IV Filing Strategy (Exclusive to the US Market)

Generic Drug Product Development (ANDA) and Paragraph IV Filing Strategy (Exclusive to the US Market)

  • Speaker: Aditya Das
  • Product ID: 702909
  • Duration: 60 Min
This webinar will help you understand the rationale for Generic Drug Product Development via an ANDA Filing and the potential added value of a Paragraph IV Application, exclusive to the US market.
CD/Recorded
$50
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Recorded/CD
FDA and MHRA Pharmacovigilance Inspection Readiness and Management

FDA and MHRA Pharmacovigilance Inspection Readiness and Management

  • Speaker: Kathleen Humel
  • Product ID: 704181
  • Duration: 60 Min
This discussion is geared for the pharmaceutical industry. It will provide pharmacovigilance (product safety) departments with solid ideas to help them prepare for and manage a health authority inspection. Medical information, research and development and quality and compliance groups in the pharmaceutical industry would benefit from tips discussed in this session as well.
CD/Recorded
$50
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Recorded/CD
Mathematics of Terminal Sterilization - Probability of Survival Approach vs Overkill Approach

Mathematics of Terminal Sterilization - Probability of Survival Approach vs Overkill Approach

  • Speaker: Jerry Dalfors
  • Product ID: 703633
  • Duration: 80 Min
This course will detail various sterilization methods and various approaches for the validation of a sterilization process.
CD/Recorded
$229
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Recorded/CD
The Microbial Factor of Non-Sterile Cleaning Validation

The Microbial Factor of Non-Sterile Cleaning Validation

  • Speaker: Steve Yeger
  • Product ID: 703360
  • Duration: 60 Min
This webinar will focus on the microbiological element of non-sterile manufacturing cleaning validation and the need to design a robust cleaning routine. It will address the different pharmacopoeia regulations and current regulatory trends. It will also cover the theory in setting the baseline profile and limits along with determination of routine testing.
CD/Recorded
$229
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Recorded/CD
Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices

Navigating the New FDA Draft Guidance on ISO 10993: Biological Evaluation of Medical Devices

  • Speaker: Cheryl Wagoner
  • Product ID: 703585
  • Duration: 60 Min
The webinar will focus on the amendments made to the Blue Book Memorandum #G95-1 Use of International Standards ISO-10993, “Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.” It will help attendees stay updated with the current trends set out by the amendments to the guideline and help them draft guidance documents that will impact their business.
CD/Recorded
$229
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Recorded/CD
FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)

FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps)

  • Speaker: Mukesh Kumar
  • Product ID: 703652
  • Duration: 90 Min
This webinar will highlight rules governing HCT/Ps using case studies. Practical suggestions for compliance with FDA requirements and tips to negotiate with the agency regarding disputes with interpretation of the law will form the core of this training session.
CD/Recorded
$229
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Recorded/CD
Good Documentation Practices (GDP)

Good Documentation Practices (GDP)

  • Speaker: Alla Teresh
  • Product ID: 703874
  • Duration: 60 Min
This training program will detail best practices for documentation, list types of documents, and highlight key documentation requirements. Documentation is essential where FDA and other health authority regulations impose a special recordkeeping burden. In these industries, documentation serves both the scientific and compliance needs, and Good Documentation Practices (GDPs) are a set of activities that enable you to record your data and hand-written entries in a legible, traceable and reproducible manner.
CD/Recorded
$229
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Recorded/CD
Designing Medical Device Alarms to Mitigate New FDA Concerns

Designing Medical Device Alarms to Mitigate New FDA Concerns

  • Speaker: Dev Raheja
  • Product ID: 702307
  • Duration: 60 Min
This training program will help attendees distinguish between urgent alarms and non-urgent alarms. It will further offer guidance on how to validate alarm effectiveness.
CD/Recorded
$50
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Recorded/CD
Corrective and Preventive Action Utilizing the Principles of Lean Documents and Lean Configuration

Corrective and Preventive Action Utilizing the Principles of Lean Documents and Lean Configuration

  • Speaker: Jose Mora
  • Product ID: 703879
  • Duration: 90 Min
This training program on lean documents will present a fresh departure from general practices, while building upon proven principles. The theory of lean documents is the product of applying lean principles to the creation, design, process, and management of controlled documents typically found in regulated industries. Just as lean principles challenge traditional process concepts and push systems, many traditional document practices are artifacts of a flawed approach. This webinar will highlight how lean configuration comes from the same principles, and utilizes the unique power of software solutions to take over functions that had previously burdened controlled paper documents.
CD/Recorded
$229
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Recorded/CD
Veterinary Drug Approval Process and FDA's Regulatory Oversight

Veterinary Drug Approval Process and FDA's Regulatory Oversight

  • Speaker: Karl M. Nobert
  • Product ID: 703971
  • Duration: 60 Min
This training program will provide attendees with an introduction to FDA’s veterinary drug approval process. It will also discuss key components of an appropriate animal field study needed to support new animal drug approval and explain how jurisdiction is split between various federal agencies in certain cases.
CD/Recorded
$0
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Recorded/CD
Monitoring Plans: 10 Rules of Effective Writing of Monitoring Plans

Monitoring Plans: 10 Rules of Effective Writing of Monitoring Plans

  • Speaker: Laura Brown
  • Product ID: 703929
  • Duration: 60 Min
This training program will discuss latest requirements for monitoring plans, content and process requirements including FDA monitoring guidance and EU requirements. The webinar will help, sponsors, and CROs in the US, EU and internationally, understand how to effectively draft monitoring plans and comply with the latest FDA and EU inspection requirements for monitoring clinical trials.
CD/Recorded
$229
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Recorded/CD
FDA Guidance on RUO (Research Use Only)/IUO (Investigational Use Only) Products

FDA Guidance on RUO (Research Use Only)/IUO (Investigational Use Only) Products

  • Speaker: Dev Raheja
  • Product ID: 703898
  • Duration: 60 Min
This FDA guidance training on RUO (Research Use Only) and IUO (Investigational Use Only) products will enumerate FDA requirements for research use only and investigational use only IVD products. The webinar instructor, an industry expert, will highlight appropriate labeling and distribution practices for RUO and IUO products and detail instructions for use of an IVD product labeled RUO or IUO.
CD/Recorded
$25
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Recorded/CD
Understanding ISO 13485 and its Relation to FDA's Quality Systems Regulation

Understanding ISO 13485 and its Relation to FDA's Quality Systems Regulation

  • Speaker: Jessica Czamanski
  • Product ID: 703630
  • Duration: 90 Min
This webinar will highlight the distinctions between ISO 13485 and FDA’s QSR. It will further introduce attendees to key clauses and requirements pertaining to the two regulations and also detail internal audit requirements.
CD/Recorded
$229
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Recorded/CD
Elements of an Effective Change Control System

Elements of an Effective Change Control System

  • Speaker: Michael Ferrante
  • Product ID: 703345
  • Duration: 60 Min
This webinar will focus on the regulatory and design requirements for an effective change control system in the pharmaceutical industry. Attendees will learn the role and importance of change control system in implementing an effective quality system.
CD/Recorded
$229
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Recorded/CD
Technology Transfer of a Pharmaceutical Manufacturing Process

Technology Transfer of a Pharmaceutical Manufacturing Process

  • Speaker: Mark Truei
  • Product ID: 703682
  • Duration: 90 Min
This expert instruction on technology transfer of a pharmaceutical manufacturing process will highlight with real world examples hidden traps in technology transfer not covered under its requirements. This webinar will help attendees ensure the success of tech transfer under any circumstance regardless of fields, countries, cultures, and applications.
CD/Recorded
$149
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Recorded/CD
Do you understand the FDA Guidance "Recognition and Use of Consensus Standards"?

Do you understand the FDA Guidance "Recognition and Use of Consensus Standards"?

  • Speaker: Cheryl Wagoner
  • Product ID: 703584
  • Duration: 60 Min
This FDA compliance webinar will discuss in detail the guidance on recognition and use of consensus standards. It will focus on the topics such as voluntary conformance, declaration review and content of declaration of conformity.
CD/Recorded
$229
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