Free Virtual Live Discussion on: COVID-19 Pandemic Measures; Impact for the life science industries
During this difficult time, those of you who are providing critical products and services in the pharmaceutical, biopharmaceutical, medical devices and allied industries have risen to the challenge to fight this pandemic in providing the ongoing health products and services to the public. Thank you!
IPA is proud to be working with a team of four industry experts to support the industry. As our panelists for this event, they are open to questions relating to challenges in the daily GMP activities concerning quality systems, facilities, laboratories, manufacture and the supply chain. The event also provides a platform for you to share experiences or changes you have made as a result of the Covid-19 outbreak which you feel would benefit others.
Industry Expert Panelists:
Agenda:
Moderator: Dr. Pauline L McGregor
11: 00 AM-11:10 AM
A brief overview of the Health Canada and FDA Expedited access guidance
Presented by: Alan Golden and Vania Davidovic
11:10 AM-11:15 AM
A brief overview on manufacturing and ways of working during a pandemic
Presented by: Michael Hodgkinson
11: 15 AM-12:00 PM
Discussion
Audience Q&A
Sharing experiences and changes as a result of the Covid-19 outbreak.
To optimize your experience, we encourage that participants come prepared for the discussion and bring any questions or experiences they could share which would help others.
About our Panelists:
Vania Davidovic, Senior QA & Compliance, Pharmaceutical Consultant
Vania is a pharmaceutical industry professional with over 20 years of experience in quality and compliance areas of pharma and biopharma industry. Vania has a strong knowledge of a wide range importer/distributer GMP activities and quality systems. She has a proven record of ensuring a high- level quality and compliance of marketed pharmaceutical and biological products. Vania is able to coordinate multiple projects, implement and improve solutions to meet regulatory, global/local and external customer requirements.She has experience with medical and pharmaceutical regulations of various regulatory bodies, including, Health Canada, FDA, VDD and CFIA. Recently retired from Boehringer-Ingelheim, Vania is taking on a pharmaceutical instructor/consultant opportunities.
Alan Golden, Principal, Design Quality Consultants, LLC
Alan has over 30 years of experience in the medical device industry, both in basic research and in quality assurance. Alan spent 31 years at Abbott Laboratories. For the first 16 years as part of diagnostics R&D, he developed recombinant proteins used in diagnostics tests, received three US patents and published numerous papers and abstracts. Alan then transitioned to a quality assurance role where in both the Abbott Diagnostics and Abbott Molecular divisions, he was responsible for quality assurance for new product development, on-market product support and operations.
Alan’s quality assurance experience extends from design control, change control, risk management, CAPA, process and test method validation and statistics. He has been lecturing on these topics worldwide for over 10 years.
Alan retired from Abbott in 2018 and now runs Design Quality Consultants, providing training, workshops and seminars in many areas of quality assurance.
Alan received his BS degree in Microbiology from the University of Michigan and his MS degree in Molecular Biology and Immunochemistry from the University of Illinois.
Michael Hodgkinson, Owner and Principal Consultant, Orvera Scientific Ltd.
Michael Hodgkinson is currently Owner and Principal Consultant at Orvera Scientific Ltd. Michael has over20 years of experience in the sterile pharmaceutical, therapeutic biologicals and vaccines manufacturing industry. He holds a Bachelor’s degree in Microbiology from the University of Guelph in Canada. He has held senior leadership roles in Canada and the United States in QC Microbiology, Manufacturing, Validation, Manufacturing Sciences, Quality Assurance and Sterility Assurance. This includes experience in design, validation, testing, risk management, contamination control and sterility assurance controls for aseptic manufacturing processes.
Pauline L McGregor, Ph.D CChem MRSC, PMcG Consulting, Canada
Dr. McGregor has over thirty years of experience in the pharmaceutical industry. She is an expert in quality systems and procedures, GMP regulations and analytical chemistry. She brings the experience and ability to customize and install the quality systems required to allow new manufacturing and testing companies to operate to GMP regulations and review and improve on current quality systems to allow more efficient operations. She also brings a technical expertise to laboratories which enable her to assist them to develop analytical procedures, validate them and optimize efficiency with regards to laboratory operations and troubleshooting in a QC environment.
She has experience in utilizing her skill set in the UK, Canada, US, Jordan, Brazil and China and has helped companies prepare for a GMP inspection to gain their European/Health Canada/FDA GMP licenses.
Pauline is a member of The Royal Society of Chemistry, UK and is on the directory for consultants. She is also a member of a USP Chemical Medicines expert committee and was a member of the USP expert panel for Validation, Verification and Transfer of Analytical Procedures.
