Angela K. Dunston
Principal, PharmaPact Consulting Services
Angela K. Dunston has over 20 years of experience in manufacturing and laboratory quality and compliance in the pharmaceutical, biotechnology, and medical device (diagnostics) industries. Her expertise is in defining, implementing, and maintaining Quality Management Systems that are cohesive and properly interact with all areas of the organization.

During these 20 years, Angela has actively participated in global regulatory inspections to include US FDA in the capacity of host, SME, and scribe. Through consulting with a variety of companies, Angela has worked with US FDA agents to ensure compliance for her clients.

The international experience obtained has assisted global organizations such as Johnson and Johnson, the Croda Corporation, Novartis, Hospira, Sanofi Pasteur, and Quintiles to exceed regulatory expectations. She has authored company best practices manuals and has trained on those procedures from the V-suite to the manufacturing floor. Angela works closely with the company’s staff to ensure a cohesive transition for non-compliance to policy approval.
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Recorded Webinar
Supplier Qualification in the Pharmaceutical Supply Chain
The importance of supplier qualification in the pharmaceutical supply chain continues to be a growing concern for global regulatory authorities. Over the past decade, there have been many instances of quality and compliance failures that have negatively impacted public health due to the lack of assurance that materials utilized in the manufacturing processes were produced under strict current Good Manufacturing Practices (cGMPs).
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Analytical Procedures and Method Validation for Drugs and Biologics
In July 2015, the FDA published an updated guidance on Analytical Procedures and Methods Validation, replacing the 2000 draft guidance with similar title and the 1987 Guidelines for Submitting Samples and Analytical Data for Methods Validation. This recent guidance represents the current thinking of the FDA on this topic. It provides recommendations on how an applicant can submit analytical procedures and methods validation data to support the documentation of the identity, strength, quality, purity, and potency of drug substances and drug products. It will help you assemble information and present data to support analytical methodologies. The recommendations presented in the guidance document apply to drug substances and drug products covered in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and supplements to these applications. The principles in this guidance also apply to drug substances and drug products covered in Type II drug master files (DMFs).
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Good Laboratory Practices (GLPs) - Comparing and Contrasting with Good Manufacturing Practices (GMPs)
The key learning objective of this webinar is to compare and contrast between Good Laboratory Practices and Good Manufacturing Practices.
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Combination Products-The FDA's New Codifications of the cGMP Requirements Applicable to Combination Products
The FDA has ensured that clear FDA requirements were in place for drugs, devices, biological produces as well as Human Cells, Tissues and Cellular and Tissue-Based Products (HCT/Ps). However, there were no regulations in place to clarify and explain the application of cGMP requirements for combination products. The FDA is seeking to change that with the issuance of a guidance document that describes and explains the final rule on cGMP requirements for combination products. This webinar is in place to describe and explain the FDA current thinking by reviewing the guidance document in detail.
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FDA's New Endotoxin Test Guidance for Human Parenteral Drugs, Biological Products and Medical Devices
The current thinking of the FDA regarding the use of the Limulus Amoebycyte Lysate (LAL) test for endotoxins in lieu of the rabbit pyrogens test has changed. As a result, the last guidance document, Guideline on Validation of the Limulus Amedocyte Lysate (LAL) Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices, which was published in 1987, has been withdrawn by the agency.
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FDA Established Conditions Reportable CMC Changes for Approved Drugs and Biologics
On June 1, 2015, FDA announced the availability of a draft guidance for industry entitled "Established Conditions: Reportable CMC Changes for Approved Drug and Biologic Products." The draft guidance is intended to address a "lack of clarity" about when chemistry, manufacturing, and controls (CMC) changes must be reported to FDA.
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Quality Metrics and Risk Based Inspections - FDA's New July 2015 Request for Quality Metrics Guidance for Industry, Safety and Innovation Act (FDASIA)
The FDA Safety and Innovation Act (FDASIA) of 2012 provides a firm legal basis for setting clearer standards for collecting data to assess manufacturing operations. Section 705 of FDASIA requires FDA to establish a risk based schedule for inspecting drug manufacturing sites, and requires access to more detailed information on facilities and quality controls. Section 706 authorizes the Agency to obtain information on drug production sites and operations in advance of an inspection. Together, these two Sections support FDA's strategy for improving how it assesses the ability of a manufacturing site to consistently produce medicines fit for intended use.
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GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry - A Review of the New MHRA GMP Data Integrity Definitions and Guidance Release in January 2015 & What to Expect from the FDA in the Future
Lapses in data integrity can hit any corporation and can be as simple as miscalculations all the way to fabrication of data, unintentional to intentional. Are you vulnerable? And do you really know if you are? Some serious failures have plagued manufacturers with FDA issuing warning letters, yet there is very scant guidance from the agency on the topic to advise us. The Europeans have detected the same data integrity issues as well but have issued guidance documents especially the MHRA to define the circumstances with clear pathways for detection and remediation. Will the FDA be far behind?
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FDA Vs Health Canada
This training program will elucidate the similarities and differences between the FDA and Health Canada promulgation s of regulations impact preparation. The course will also offer a review of the background and history behind the FDA and Health Canada.
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