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 – Optimization of a Pharmaceutical Granulation Process using Quality by Design (QbD)
2019-07-31 - 2029-07-25
Recorded Webinar – Optimization of a Pharmaceutical Granulation Process using Quality by Design (QbD)

Recorded Webinar
Time: 1 Hour
Cost: CAD$600+HST
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Distinguished Faculty
Andy Tallevi Formulation/Process Consultant
Keller Consulting

Andy Tallevi is a Formulation/Process Consultant for Keller Consulting in Mississauga, Ont., Canada. He has 28 years of industrial experience, primarily in the Pharmaceutical industry. He currently consults clients in the Pharma and chemical industries assisting them with formulation and process issues and is an instructor at AAPS.
Most recently Andy spent 1 year with Health Canada in the Bureau of Pharmaceutical Sciences reviewing and evaluating generic submissions and making recommendations for approval or refusal of Notice of Compliance for the Bureau. He has gained significant insights to the regulatory requirements and expectations of the drug substance and drug product sections of a submission filing to Health Canada. In addition, he has an excellent understanding of the regulatory requirements for pharmaceutical development, the GMP requirements expected for pharmaceutical manufacture and has assisted former employers numerous times in audits by Health Canada and the FDA.
Prior to this, Andy worked as a Senior Pharmaceutics Scientist for GlaxoSmithKline in Canada. During his 18 years with the company he led many projects developing new chemical entities in varying dosage forms. His specialty is solid oral dosage forms. He and his team successfully formulated immediate release tablets as well as many controlled release versions of GSK new chemical entities. He has experience with conventional matrix approaches as well as proprietary technologies such as Procise® and DiffCORE®. He has been responsible for overseeing the manufacture of clinical supplies of NCEs both in Canada and at other GSK sites in Europe and the US.
Andy also has a solid understanding of material properties required of excipients and actives for successful formulation and for robust processes. He is well versed on particle sizing and powder flow. He holds a US patent on a novel approach for the assessment of the flow of pharmaceutical powders.
Prior to leaving GSK he was heavily involved in a company-wide effort to strengthen its processes by Design for Manufacture through the use of PAT and experimental design for which he was the lead user in Mississauga.
Prior to GlaxoSmithKline Andy worked as a scientist for Unilever developing products in the health, beauty and detergent industries. He graduated from the University of Toronto with a B.Sc. major in Chemistry.
Andy lives in Mississauga with his wife and 2 children.
Course Overview
For many years pharmaceutical companies have placed considerable effort in developing robust manufacturing processes to assure the highest quality products, minimize defects, eliminate rejects and conform to all Regulatory requirements. These processes are developed by scientists using past knowledge and 1 variable-at-a-time experiments and then subjected to process validation. Unfortunately, more often than not, even validated processes fail.
At the core of this problem is the fact that full process knowledge has not been acquired and all critical factors have not been identified. This implies that the manufacturing process can drift into a region not fully explored and produce an output that falls outside acceptable limits.
For the past decade and more the pharmaceutical industry, supported by Regulators, has been looking to Quality by Design (QbD) to remedy this problem. In pharmaceutical manufacturing the concept is to carry out experimentation and analysis using multivariate statistical techniques to determine all the factors influencing the process (critical factors), determining the complete region around those factors that produce a given output (design space) and then determining the optimal portion of the design space that produces the desired output within limits (optimization).
In this webinar participants will learn about:

Basic concepts of Quality by Design (QbD)
Advantages of QbD over traditional 1 variable-at-a-time experimentation
Statistical experimental design
Critical factors
Factor interactions
Design space
Interpretation of data derived from QbD
A real life example of QbD applied to a pharmaceutical granulation process to fully understand the critical factors and the optimal operating range within the design space for those factors

Who Should Attend
The webinar is suitable for those who are seeking to get a basic understanding of the concept of Quality by Design and its application to pharmaceutical processing including personnel in Production, Quality Assurance, Quality Control, Validation and Development.

Recorded Webinar – GMP Compliant Temperature Mapping
2019-07-31 - 2029-07-31
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.
