Recorded Webinar – Good Documentation and Record Keeping Practices for Cannabis
|Recorded Webinar||Time: 2.5 Hours||Cost: CAD$600+HST||Buy Now!|
Mr. Steven Tanner has worked for and partnered (GQRP) with the top global pharmaceutical manufacturing, contract research, wholesale and specialty distribution organizations in both Europe and North America. From Eli Lilly UK to Merck KGaA (now Mylan) in Canada, Pharmanet (now Inventiv Health), Teva, and the McKesson Corporation, Steven now surpasses more than 18-years of progressive GxP industry experience in quality, compliance and technical training senior leadership roles.
Steven’s specialties include leading FDA and Health Canada GMP inspections, customer 3rd party logistics (3PL) quality & qualification audits, as well as the hands-on design, strategy, execution and management of GxP regulatory quality systems: change controls, deviation controls, CAPA, validation/21 CFR Part 11, document controls, environmental monitoring, complaints, equipment & shipment qualifications, SOPs, technical writing, drug recalls, quality agreements, self-inspections. Steven has also partnered since 2004 with AAPS – Academy of Applied Pharmaceutical Sciences where he’s provided quality assurance/GxP technical facilitation. In 2016 Steven accepted a full-time role as Campus Manager and Director of Student Affairs with AAPS.
Steven graduated in 1999 with an honours degree in Chemistry from Leicester University in the United Kingdom and holds a postgraduate diploma in Adult Education from St Francis Xavier University, Nova Scotia, Canada.
Record Keeping is of vital importance to the regulated cannabis industry because it supports various important functions including making or breaking Health Canada inspections. Documentation is the legal proof that work was adequately performed and provides a written history of company and products, as well proving to regulators that the company follows its regulatory commitments. Retention periods for the cannabis industry can be up to 25 years for some records, therefore they must be appropriately protected whether it be on or off site.
- Regulatory Requirements for Documentation/Record Keeping
- Readiness of Documentation for Inspection
- Distribution of Documents
- Archiving on/offsite
- Temperature/Humidity Concerns
- Retention Periods
- Adverse Reactions and Adverse Reactions Reporting
Note: Course outline is subject to change without notice. Please check back regularly for updates.
Who Should Attend
This webinar is valuable for Directors, Managers, Supervisors, Associates in the Pharmaceutical, Biopharmaceutical, Vitamins, Herbals, Medical Devices and allied industries with daily responsibilities in the following areas:
- Regulatory Affairs
- Quality Assurance
- Documentation and Technical Writing
- Project Management
- Product Development