AAPS

Recorded Webinar – Lean for Root Cause Analysis and Corrective Action
2019-07-31 - 2029-07-31 | AAPS Training Center, 200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4, Canada
Recorded Webinar – Lean for Root Cause Analysis and Corrective Action

Recorded Webinar
Time: 2 Hours
Cost: CAD$600+HST
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Distinguished Faculty
Dwight Bryan President & Principal Consultant
The Bryan Consortium Inc.

Dwight Bryan has over 20 years’ of experience in the Pharmaceutical and Medical Device Industries. He has held roles of increasing responsibility in Finance, Sales, Learning & Development, Sales Management and Continuous Improvement at Eli Lilly Canada. He has also held lead roles in the deployment of Lean transformations at Cardinal Health, Novo Nordisk and AstraZeneca. He now leverages his expertise as a Lean consultant to the pharmaceutical industry and other healthcare related organizations.
Dwight obtained his B.Sc. in Mathematics and Computer Science from the University of the West Indies, and subsequently completed his MBA in Finance at the Schulich School of Business. He is also a certified Lean Six Sigma Black Belt. For over a decade Dwight has utilized his process improvement skills to address complex business processes which impact quality and customer satisfaction. He has led cross-functional initiatives that have impacted Quality Assurance, Regulatory Affairs and Supply Chain among other areas.
Some projects he has undertaken include improving the Quality Management Review Process, streamlining and enhancing compliance for the distribution of cold chain pharmaceutical samples and eliminating delays in product transitions. Dwight has also led cultural transformations by engaging staff in Lean, including training scores of individuals and certifying them at various levels of Lean proficiency.
Course Overview
A key role for Quality Assurance professionals is identifying and addressing deviations from standard operating procedures and regulatory requirements. In order to effectively prevent recurrence of the events, it is very important to correctly identify and address the underlying root causes. This not only involves dealing with specific incidents but also taking a holistic view of the process to ensure that it is fundamentally sound and is designed in such a way as to minimize the occurrences of deviations. This workshop will leverage Lean principles to get beyond the common root cause identification of “human error”. The tools and techniques presented in this course can be applied to everyday work to make processes simpler and reduce the time and effort required to complete daily tasks.
Course Outline

Introduction to Lean
Essentials for Good Processes (5 Principles of Lean)
Identifying Non-Value Added Activities (8 Wastes of Lean)
Lean Problem Solving Methodology
Effective Problem Definition
Root Cause Identification
Process Mapping
Corrective Action Development
Confirmation of Results

Note: Course outline is subject to change without notice. Please check back regularly for updates.
Who Should Attend
This one-day course 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:

Quality Assurance
Regulatory Affairs
Operations
Training & Development
Documentation and Technical Writing
Project Management

Recorded Webinar – GMP Compliant Temperature Mapping
2019-07-31 - 2029-07-31 | AAPS Training Center, 200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4, Canada
Recorded Webinar – GMP Compliant Temperature Mapping

Recorded Webinar
Time: 1.5 Hours
Cost: CAD$600+HST
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Distinguished Faculty
Ms. Deborah Gordon B. Sc

Instructor and Program Chair
AAPS

Deborah Gordon, B. Sc., Dip. Pharm. QA, began her career in the Sciences as a Forensic Analyst working on crime scenes and in the lab, analyzing evidence to be presented in court. Her attention to detail, which was critical to crime scene investigation, eventually led her to the Quality Assurance field. Her experience as a Forensic Analyst paved the way for her career growth. In 2008, Deborah completed her training as an Auditor by successfully passing the American Society for Quality Auditor examination, (ASQ, CQA).
Deborah has 16 years of experience in the pharmaceutical industry, including 15 years of auditing experience. Her experience includes Quality Systems for storage, distribution, wholesaling, packaging/labeling and manufacturing of pharmaceuticals. She has done extensive work in temperature mapping of warehouses, fridges and freezers. As a leader in pharmaceutical quality assurance, she also enjoys the challenge of auditing and teaching.
Abstract
Health Canada Guide 0069, Temperature Control of Drug Products during Storage and Transportation requires drug products to be “transported, handled and stored in a manner that mitigates the risk of exposure to temperatures outside labelled storage conditions; potentially impacting the safety, quality and effectiveness of the drug product…..fabricators, packagers/labelers, distributors, importers and wholesalers are additionally responsible for the appropriate handling, storage and distribution of drugs according to C.02.015 of the Food and Drug Regulations”. Other Regulatory bodies such as the FDA also require the temperature of storage areas to be maintained in accordance with labelled storage conditions in order to maintain drug safety, quality and efficacy.
GMP Temperature Mapping should be completed on a periodic basis, for example every three years in order to demonstrate continuing compliance. Temperature Mapping should also be completed when significant changes have been made to the equipment and storage areas which could impact air circulation or loading or unexplainable variability in temperature occurs outside of the specifications.
Topics to be covered
This webinar will assist Companies in understanding the Regulatory requirements for conducting a GMP Compliant Temperature Mapping of their facility. Participants will learn how to complete a risk assessment, document a Temperature Mapping Protocol and a Summary Report.
The course details will include:

Definition
Temperature Mapping Introduction
Why should you comply?
What is a Quality Product?
How do we achieve Compliance
Environmental Controls
Application of Controls
Selection of data loggers
When should temperature mapping be completed?
Audit and Risk Assessment
Temperature Mapping Protocol
Methodology
Review and Data Analysis
Summary Report
Impact of not completing Temperature Mapping
Final Advice

Who should attend
Wholesalers, Distributors, Importers, Manufacturers, Quality Assurance Directors and Managers, Operations Managers who have direct responsibility for Quality Management; Quality Unit, Regulatory Affairs, Consultants, Auditors.

Recorded Webinar Cannabis Licensing Process and Application Guide
2029-07-31 | Ontario
Recorded Webinar – Cannabis Licensing Process and Application Guide

Recorded Webinar
Time: 1.5 Hours
Cost: CAD$600+HST
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Distinguished Faculty
Ms. Laleh Bighash
Dean of Pharmaceutical & Scientific Affairs and Chief Operating Officer (COO)
AAPS

Ms. Bighash is the Dean of Pharmaceutical & Scientific Affairs and Chief Operating Officer (COO) of the Academy of Applied Pharmaceutical Sciences (AAPS) – a registered career college by Ministry of Colleges and Universities offering applied education and hands-on training for the pharmaceutical, biopharmaceutical, and allied industry.
Ms. Bighash has a B.Pharm degree as well as the Bachelor degree in Pharmacology and Toxicology from University of Toronto, Canada. She also obtained her Masters degree in Business Administration (MBA) from Schulich School of Business in Toronto, specializing in Finance and Strategy.
In her current role as the Dean of Scientific Affairs and Chief Operating Officer of Academy of Applied Pharmaceutical Sciences (AAPS) Inc. She manages the educational and training direction of the college. Her activities include management of industry and government relations, overseeing of student, faculty, and staff activities and development of education policies and course contents of the AAPS programs.
Ms. Bighash is a co-founder and past Editor-in-chief of Canada’s only Pharmaceutical and Biopharmaceutical Trade magazine and executive director of Ontario Association of Career Colleges. She has lectured extensively and has been an invited speaker at many academic and industry events.
Her Professional career includes working for number of multinational pharmaceutical companies such as Genpharm Inc., Bayer Corp. and Eli Lily.
Course Overview
The Cannabis Act establishes that an application for a licence must be filed with Health Canada in the form and manner specified by the Minister and must include the information required by the Minister.
The application process to obtain a licence under the Cannabis Act is complicated and undergoes a strict and thorough review by Health Canada. The applicant must ensure that the information provided in the application is detailed and accurate and clearly demonstrates that they are compliant with all the requirements of the Act. Insufficient or inaccurate information may give rise to grounds for refusal.
This recorded webinar discusses the application process including the form and manner for submitting an application for a licence and the information that is required to be submitted.
Course Outline

Background
Cannabis licence classes and subclasses
Cannabis Tracking and Licencing System (CTLS)
Application process and steps
Application documentation required
Key positions, site personnel and security clearances
Site security plan
Organizational security plan
Site & building information
Good Production Practices (GPP) plan
Record keeping and reporting methods
QA person, master grower, head of security, head of client services, SPIC, RPIC
Notices to the local authorities
Approval process
Refusal and withdrawals
Changes to the application
Current licences transitions – Equivalent licences under the Cannabis Act
Application costs and Cost Recovery Proposals – fees

Who Should Attend
Cannabis industry participants including employers and employees, those who are interested in joining the industry, licensed applicants, and suppliers to the industry

Recorded Webinar – Cannabis Industry Complaints and Recalls
2029-07-31 | AAPS Training Center, 200 Consumers Road, Suite 200, Toronto, Ontario, M2J 4R4, Canada
Recorded Webinar – Cannabis Industry Complaints and Recalls

Recorded Webinar
Time: 1.5 Hours
Cost: CAD$600+HST
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Course Overview
This webinar examines the application of ACMPR – Access to Cannabis for Medical Purposes Regulations GPP Good Production Practice requirements applicable to Product Recalls and Complaints for the cannabis industry and consequences of inaction.
Gain practical knowledge in understanding of the essential elements for maintaining compliance in the cannabis industry.
Course Outline

Recall and Recall Reporting per ACMPR GPP regulatory requirements
Standard Operating Procedure requirements
Quality Assurance roles/responsibilities
Adverse Reactions and Adverse Reactions Reporting
Consequences/case studies

Note: Course outline is subject to change without notice. Please check back regularly for updates.
Who Should Attend
This course is valuable for Directors, Managers, Supervisors and Associates in the medical cannabis industry with daily responsibilities in the following areas:

Regulatory Affairs
Quality Assurance
Operations
Training
Consultants
Research
Documentation and Technical Writing
Project Management
Product Development
Growers
