Gwendolyn Wise-Blackman
Manager, Quality Assurance, Analytical Sciences at Salix Pharmaceuticals
Gwendolyn Wise-Blackman is a successful scientist/manager with increasing accountability for scientific expertise and budget in the pharmaceutical industry, including managing multiple projects. She has working knowledge of FDA/ICH GLP and GMP guidelines and has proven experience with cell-based potency assays, Cell-based neutralization assays, PK and immunogenicity ELISA used to support bioprocess techniques for large molecule therapeutics. Ms. Wise-Blackman also holds Research & Development expertise in High Throughput Screening, 7-transmembrane receptor binding assays, cell-based assays, cell culture, and ELISA. Ms. Wise-Blackman is gifted with excellent presentation skills as evidenced by numerous scientific speaking engagements and working knowledge of PMP principles. She was an invited lecturer for IBC and IVT conferences, 1999-2008.
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Recorded Webinar
Implementing a Stability Program for a Biologic
This Biologic stability webinar will discuss the issues present during design and implementation of stability program for large molecule therapeutics. We will discuss the design and validation of stability indicating methods and expiry dating.
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CMC Requirements for Cell and Gene Therapy
Cell and gene therapy is an exploding area of new technology and innovation in the pharmaceutical industry. Mapping of the human genome that led to discovery of pathways for intervention in disease states drives this innovation in drug development. Many of these discoveries are improving the prognosis of diseases that previously had no therapeutic intervention. As more customized therapeutics and cell-specific therapeutics are developed for use in treating a variety of diseases, FDA Guidance for Industry Documents play a key role. Regulatory expectations are still an important part of the process. These regulatory documents are necessary to ensure quality and safety parameters are established and met. This webinar will address the impact of this new technology and the response of the FDA toward regulating quality and safety.
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21 CFR 111 GMP Dietary Supplement Laboratory
Dietary supplements are governed by 21 CFR 111 in production, testing, storage and distribution. Although dietary supplements are not pharmaceuticals they are still subject to stringent regulations designed to insure safety and consistency of the products. This webinar will address multiple subparts of 21 CFR 111 specifically discussing laboratory facilities, equipment/instrumentation and process controls.
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Implementation of Risk Evaluation and Mitigation Strategy (REMS) - What do you need to do now?
Attendees will receive knowledge on important and essential requirements related to Risk Management for potential pharmaceutical adverse effects. This webinar will provide basic understanding of requirements for REMS and steps to consider for implementation.
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Bioassay Development and Method Validation
The pharmaceutical industry has seen an increase in the number of biologics released to fight human disease. Large molecule therapeutics requires additional consideration when developing and validating supporting methods. This webinar will address steps to consider when developing bioassays with the expectation of successful completion of validation. Specifically, this webinar covers essential concepts related to cell-based potency methods, ELISA, and other methods supporting biologics. Specific topics covered in the webinar will include cell culture, multitrack development strategies, DOE, assay variability, and the validation protocol. Attendees will receive information that should be beneficial in helping to achieve well-controlled validated bioassay methods.
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Stability Testing for Biological/Biotechnological Drug Substances and Drug Products
All drug substances and drug products require expiration dating. Data used to support and set expiry and shelf life must be collected and analyzed using guidelines set by regulatory agencies. Processes and considerations for small molecules are inadequate for large molecule therapeutics when planning for expiry dating. One issue to consider is that the complexity of large molecule therapeutics allows for a greater potential to lose potency through multiple pathways. This webinar addresses issues present when designing and implementing a stability program for large molecule therapeutics. Key topics will be addressed to provide insight into important issues that should be considered to assure maintenance of potency during shelf life of the product.
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GMP Auditing of Facilities Performing Cell-Based Methods
Laboratories that perform cell-based methods must meet stringent GMP guidelines for analytical procedures. In addition, standard operating procedures that specifically address working with cells should be in place to maintain control of a live assay system. GMP inspections should cover additional topics in cell-based laboratories to confirm procedures are sound from a regulatory perspective.
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Common Problems and Mistakes in Method Validation in Drug Development Process
Validation of test methods is a critical requirement for the drug development process. Testing of drug substance and drug product for quality requires validated methods. In addition, testing samples for PK/PD studies requires methods that are consistent, robust, rugged, sensitive, and specific in a variety of matrices. Collecting sufficient data prior to validation that can reliably support acceptance require is a frequent issue. Setting appropriate acceptance criteria based on data from final development and qualification is important for assay performance in the validation. This webinar will address issues that arise during development and validation that lead to failure and rework. The webinar also includes approaches to validation that can prevent failure and increase successful completion of validation.
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Implementation of Risk Evaluation and Mitigation Strategy (REMS) Programs in a Health System
Pharmaceutical and biologic products may have adverse effects. This can be observed either in general or in specific patient populations. Adverse effects may be related to class and structure and may be observed after approval of the drug. Strategies must be in place if a pharmaceutical or biologic product is deemed to likely have or is observed to exhibit a harmful response in addition to the health benefit. To assure public safety, the FDA requires implementation of a plan designed to mitigate the risk. These plans are developed as part of a risk evaluation and mitigation strategy (REMS).
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Microbial Control, Monitoring and Validation of Water Systems for Pharmaceuticals and Biologics
This webinar will discuss the FDA requirements for design, validation and monitoring of pharmaceutical water systems. There are many different types of pharmaceutical waters and each must be fit for its intended use. Pharma water must be controlled microbially and for other impurities. Pharma water systems must be designed, validated and monitored to ensure that the water produced meets specifications around the clock. Learn common pitfalls with water system design and use and how to avoid them. Get your pharma water questions answered in this webinar.
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21 CFR 111 GMP Dietary Supplement Laboratory
Dietary supplements are governed by 21 CFR 111 in production, testing, storage, and distribution. Although dietary supplements are not pharmaceuticals they are still subject to stringent regulations designed to insure safety and consistency of the products. This webinar will address multiple subparts of 21 CFR 111 specifically discussing laboratory facilities, equipment/instrumentation and process controls. In addition, product controls, SOPs, standard methods, product specific methods, and product specifications are presented in this webinar. Trained personnel, records, and quality control are additional topics addressed to insure a broad overview with attention to several specific details related to proper manufacture, testing, storage, and shipping of dietary supplements.
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Conducting GMP Inspections of Laboratories Performing Cell-Based Methods
Cell-based laboratories are responsible for analytical data of biopharmaceutical products. Included in this analysis are cell-based methods that determine the potency of the product. This webinar will discuss key points to assess during the preparation and performance of GMP laboratory inspections/audits. Included in this presentation are suggestions for specific items to review and negotiate changes to procedures. The quality or laboratory professional who attends this webinar will gain knowledge useful in addressing and maintaining a quality method in a cell-based laboratory.
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Validation of Complex Cell- Based Potency Methods
Some cell-based methods are multifaceted. This webinar will address development and validation of complex cell-based methods. It will discuss the selection of the method and the cell line, correlating the method with the pharmaceutical activity, the need for orthogonal methods, and the timeline for method validation. The areas covered in this presentation include:
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