Gregory Martin
President at Complectors Consulting LLC
Greg Martin is the President of Complectors Consulting, which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years experience in the pharmaceutical industry and was the Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. In addition, he has volunteered for the USP for over 10 years, and currently serves on the General Chapters - Chemical Analysis Expert Committee, and serves on Expert Panels on Validation and Verification, Residual Solvents and Use of Enzymes for Dissolution Testing of Gelatin Capsules.

He has particular interest in QbD/Lean approaches to dissolution testing, impurity methods, method lifecycle (development/validation/transfer) and instrument qualification, and is passionate about using good science and sound logic to achieve high quality results, consistent with cGMPs, while minimizing resources. Mr. Martin is the author of several papers in the areas of dissolution and analytical method validation, and was the past chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.
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Recorded Webinar
System Suitability Testing in the Pharmaceutical Laboratory: Addressing FDA and USP Compliance
Due to the criticality of the data generated in a pharmaceutical laboratory, System Suitability Testing (SST) has been implemented to provide input on a daily basis about whether or not an analytical method is performing as intended.
Recorded Session Get life time access for one participant with download option!

Analytical Instrument Qualification - Practical Approaches for Revised USP General Chapter 1058 Compliance
The first version of USP <1058> has been released in 2008. Since then it has evolved to the global standard for analytical instrument qualification. In August 2017 a new revision has been released with many new requirements mainly addressing the needs of quality systems, e.g., risk based implementation, quality agreements between service/system providers and users, and regular reviews to ensure ongoing performance. This webinar will discuss all details and give strategies and case studies for easy implementation.
Recorded Session Get life time access for one participant with download option!

Residual Solvents: Take Advantage of the New Flexibility in Revised USP 467
This training on residual solvents will discuss the regulatory landscape for residual solvents and compliance requirements, including interpretation of the majors sections (classes of solvents, options for describing levels, analytical procedures).
Recorded Session Get life time access for one participant with download option!

Elemental Impurities Tests for Pharmaceutical Products according to the ICH Q3D and USP 232/233 Guidelines
Manufacturers of pharmaceutical drug products must comply with USP <232>/<233> and ICH Q3D requirements of elemental impurities for most pharmaceutical products. These requirements cover more metals and require lower limits than the antiquated Heavy Metals test. Additionally, the analytical technique, ICP-MS, is much more challenging. By attending this course you will learn about the new requirements and also about using risk assessment to minimize unnecessary testing and meet FDA expectations.
Recorded Session Get life time access for one participant with download option!

QbD Approach to Analytical Method Lifecycle: Design, Development, Validation, Transfer
This 90-minute webinar on using the QbD Approach to Analytical Method Lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements.
Recorded Session Get life time access for one participant with download option!

QbD Approach to Analytical Method Lifecycle: Design, Development, Validation, Transfer
This 90-minute webinar on using the QbD Approach to Analytical Method Lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements.
Recorded Session Get life time access for one participant with download option!

Residual Solvents: Take Advantage of the New Flexibility in Revised USP <467>
This training on residual solvents will discuss the regulatory landscape for residual solvents and compliance requirements, including interpretation of the majors' sections (classes of solvents, options for describing levels, analytical procedures).
Recorded Session Get life time access for one participant with download option!

Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results
This training on pharmaceutical laboratory OOS investigations will explain how to recognize and address atypical or out of specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations.
Recorded Session Get life time access for one participant with download option!

New Elemental Impurities Tests for Pharmaceutical Products According to the New ICH Q3D and USP 232/233 Guidelines
The deadline for implementation of the new elemental impurities guidelines for drug products and ingredients is fast approaching. Implementation is scheduled for January 2018, by which time manufacturers of pharmaceutical drug products must comply with USP <232>/<233> and ICH Q3D.
Recorded Session Get life time access for one participant with download option!

QbD Approach to Analytical Method Lifecycle: Design, Development, Validation, Transfer
This 90-minute webinar on using the QbD Approach to Analytical Method Lifecycle is designed to provide participants with a lifecycle approach to developing and validating analytical methods and comply with compendial requirements.
Recorded Session Get life time access for one participant with download option!

System Suitability Testing in the Pharmaceutical Laboratory: Addressing FDA and USP Compliance
Due to the criticality of the data generated in a pharmaceutical laboratory, System Suitability Testing (SST) has been implemented to provide input on a daily basis about whether or not an analytical method is performing as intended.
Recorded Session Get life time access for one participant with download option!

Troubleshooting OOS or Unexpected Dissolution Results - An Advanced Course Using Root Cause Analysis with the Ten Most Common Causes
Investigations into unexpected results are usually time consuming and fraught with anxiety, as well as being subject to Regulatory inspection. Using a Root Cause Analysis approach can reduce the time necessary to complete the investigation and simultaneously help, by pointing to appropriate Corrective and Preventive Action (CAPA) reduce the probability that additional OOS results from the same cause will be observed.
Recorded Session Get life time access for one participant with download option!

New Elemental Impurities Tests for Pharmaceutical Products according to the new ICH Q3D and USP 232/233 Guidelines: Are you ready for January 2018 deadline ?
The deadline for implementation of the new elemental impurities guidelines for drug products and ingredients is fast approaching. Implementation is scheduled for January 2018, by which manufacturers of pharmaceutical drug products must comply with USP <232>/<233> and ICH Q3D.
Recorded Session Get life time access for one participant with download option!

Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory
This 90 Min laboratory inspection webinar will discuss strategies to implement before your laboratory is about to undergo a pre-approval inspection or a general GMP inspection. It will help you gain an understanding of the key areas that are likely to be the subject of a laboratory inspection.
Recorded Session Get life time access for one participant with download option!

Conducting Effective Investigations of Out of Specification and Atypical Laboratory Results
This training on pharmaceutical laboratory OOS investigations will explain how to recognize and address atypical or Out Of Specification results, using approaches which have been recommended by regulatory authorities, performing appropriate investigations.
Recorded Session Get life time access for one participant with download option!

FDA's Update on Elemental Impurities According to the new ICH Q3D and USP 232/233 Guidelines - Are you ready?
New, dramatically different requirements for elemental impurities will soon be introduced for most pharmaceutical products. These requirements cover more metals and require lower limits than the antiquated Heavy Metals test. Additionally, the analytical technique, ICP-MS, is much more challenging. By attending this course you will learn about the new requirements and also about using risk assessment to minimize unnecessary testing and meet FDA expectations.
Recorded Session Get life time access for one participant with download option!

Writing Effective SOPs for the GMP Laboratory
This course is designed to provide participants with tools for writing effective Standard Operating Procedures. A general process for creating and implementing SOPs will be presented, including discussion on the important sections which should be included in each SOP, how to generate the consensus ultimately required for the SOPs to be followed consistently, training requirements and post-implementation evaluation and periodic review. We will discuss a list of SOPs which every analytical laboratory should have.
Recorded Session Get life time access for one participant with download option!

Introduction to Dissolution Method Development & Validation
This webinar is designed to assist in dissolution to design, develop, and validate dissolution methods. Dissolution testing is used to demonstrate the performance of drug products throughout the product lifecycle. The webinar uses the Method Lifecycle concept to address method requirements in the Analytical Target Profile, then proceeds through Method Design, Development and Understanding followed by Validation, and continues through method routine use and changes.
Recorded Session Get life time access for one participant with download option!

Elemental Impurities: The New Requirements
This webinar is designed to provide a comprehensive overview of impurities which must be controlled in pharmaceutical products. It will also provide detailed review of the guidance documents related to each of the categories of impurities and strategies to address each, including reporting of test results.
Recorded Session Get life time access for one participant with download option!

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