Good manufacturing practices are critical to everyday operations in the pharmaceutical industry. The basic principles of GMP are to assure the quality, potency, identity, safety and purity of products and to protect both the consumer and the company.
This course provides a refresher of Good Manufacturing Practices based on current Health Canada and FDA guidelines. It bridges the gap between the black and white regulations and everyday operations by describing the regulations and the practical application of them through key quality system elements, essential to GMP compliance. The course material is presented by means of slides, handouts and participation of the attendees through discussion and group exercises.
Hands-on exercises enable participants to map their individual GMP responsibilities and gain the skills and knowledge necessary to understand and work in a GMP compliant environment and contribute to the ongoing quality of their company.
The course is presented in a dynamic environment created by a power point presentation, interactive exercises, and group discussion. The final session includes a fun, team trivia quiz
This is a 1 day course geared towards a general audience with a range of experience and job descriptions. Individual questions are addressed throughout, and interactive exercises are designed to allow maximum benefit to all regardless of experience.
These are customized to suit the licensed GMP operations within your company. Can be presented as refresher training, new employee training, job specific GMP training or a training session to address deficiencies noted by regulatory authorities, customer audits or your internal self- inspection program.
This course is designed to provide essential training for conducting Out of Specification (OOS) investigations in a GMP environment in accordance with the FDA 2006, 2018 Health Canada GMP 2018 and MHRA 2012 guidelines. A short discussion on Out of Trend (OOT) results is also included. The focus will be on those results generated during laboratory testing including a step-by-step approach on how to conduct and document an OOS result investigation in compliance with an FDA or Health Canada audit. A background discussion of the associated GMP documentation required to support the OOS investigation is included but the majority of time is spent detailing the who, what, when, how and why of the investigation, determining the extent of the investigation during Phase I, the decision to go to phase 2, documenting findings and following up on corrective and preventative action plans.
This course is presented in a dynamic environment created by a PowerPoint presentation, interactive exercises, case studies and group discussion.
Data Integrity is paramount for traceability of data and events occurring in the lifecycle of a product. It applies equally to both paper and computerized based systems. Although its main area of application is in the laboratory and manufacturing, it also applies to quality systems, the generation and review of records and ongoing monitoring of data management throughout the GMP activities across the supply chain.
Regulatory Agencies require written procedures for all systems and operations which impact the quality and safety of pharmaceutical products. Standard Operating Procedures (SOP’s) provide the main forum for the documentation of a Company’s systems and operations. SOP’s are therefore among the main documents audited by Regulatory Agencies during GMP inspections to ensure they reflect current practices and are followed as written.
The course reviews regulatory authorities’ expectations and guidelines relating to SOP’s and their role in global harmonization, good documentation practices and GMP. It then launches into a series of topics, interactive exercises and group discussion on how to write effective SOP’s and manage and maintain this critical documentation system. This course provides helpful information associated with the writing, formatting, execution and management of SOP’s. The course material is presented by means of slides, handouts and participation of the attendees through discussion and group exercises.
It enables participants to gain the skills and knowledge necessary to meet the FDA, Health Canada’s and other regulatory agencies’ expectations for SOPs.
The pharmaceutical industry has traditionally treated analytical procedures via a well-defined sequence of development, validation and transfer exercises in line with agreed standards such as the quality guidelines ICH Q2 (R1). So why do we have so many problems when we use these validated procedures in a routine environment or try to transfer or verify them? When such problems occur, they are accompanied by time consuming investigations to determine what went wrong and then more time is spent on trying to resolve the issues.
This 2-day workshop provides a brief overview on the limitations of current practices of development, validation, verification and transfer of analytical procedures. It then demonstrates how QbD concepts can be applied to the lifecycle of an analytical procedure including development, validation, verification, transfer and continual monitoring of routine performance.
A fun, hands on exercise using a Statapult is utilized to explore how uncontrolled variables can affect the output of the analytical procedure and how to assess and control them.
This course is based on the approach described in ICH Q8, Q9 and Q10 and the stimuli articles published by the USP expert panel for validation, verification and transfer of analytical procedures.
The course focuses on HPLC procedures; therefore, experience in developing, validating and transferring analytical HPLC procedures would be an advantage to participants.
This 1-day course is aimed at Quality Assurance auditors (or potential auditors) who work in a GMP environment. The course considers your roles both as an auditor and an auditee.
As part of GMP compliance a company should have internal and external audit programs operating as part of an integrated quality system. Internal audits are designed to consider quality and risk management principles to ensure ongoing GMP compliance and identify quality improvements. External audits ensure any outsourced activities or suppliers conform to your companies GMP requirements. This course also helps you to prepare for audits form regulatory authorities.