Dr. Gwen Wise-Blackman
Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), Covance, and Salix Pharmaceuticals. Her focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, and Quality Assurance. Gwen has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from UVa. She is a member of ASQ and AAPS.
21 CFR 111 GMP Dietary Supplement Laboratory
This training program will provide an overview of 21 CFR 111 regulatory requirements which governs how dietary supplements are manufactured and tested It will futher review the test procedures and documentation requirements to ensure reg ...
- Basic & Advanced
- 60 Mins
Validation of Complex Cell-Based Potency Methods
This webinar will address development and validation of complex cell-based methods some cell-based methods are multifaceted Will discuss the selection of the method and the cell line, correlating the method with the pharmaceutical activi ...
- Basic & Intermediate & Advanced
- 60 Mins
Assessing Immunogenicity to Biologics
Immune responses in the patient population during clinical trials or during post-market pharmacovigilance are a serious issue facing biologic therapeutics. Similarity to critical proteins in human physiology or possible interference with en ...
- Basic & Intermediate
- 90 Mins
Stability Programs for Small Molecules
Therapeutic agents require testing for stability. Documenting the stability of the drug substance or drug product in different storage conditions is essential for setting specifications for expiry and shelf life. Understanding the possible ...
- Intermediate
- 60 Mins
Developing and Validating Methods Supporting Biologics
Biologics continue to be a steadily growing component of the pharmaceutical industry. The advent of large molecule therapeutics requires a different perspective on the assays needed to support development through preclinical and clinical te ...
- Intermediate
- 120 Mins
Reducing Variability in Cell-Based Methods Using Process Controls
Cell-based methods are known for variability. Living systems introduce complexity not present in simple in vitro methods. Responses to small changes in reagents, in analyst technique, and in the environment can have a major impact on cell-based s ...
- Basic & Intermediate
- 60 Mins
Assessing Immunogenicity to Biologics
Immune responses in the patient population during clinical trials or during post-market pharmacovigilance are a serious issue facing biologic therapeutics. Similarity to critical proteins in human physiology or possible interference with endogenou ...
- Basic & Intermediate
- 90 Mins
Technology Transfer for Pharmaceutical Processes and Test Methods
Technology transfer is crucial to conveying information and knowledge between independent sites at a single company or between different workplaces. Transferring technology is frequently necessary for process development, manufacturing, and analyt ...
- Intermediate
- 60 Mins
Overcoming Challenges in the Development and Validation of Cell-Based Methods
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support. Unlike analytical test methods for small molecule ...
- Intermediate
- 90 Mins
Validation Challenges for Cell-Based Methods
Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support. Unlike analytical test methods for small molecule ...
- Intermediate
- 90 Mins