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.
This 2-day training course integrates the following principles of QbD and the lifecycle management approach to analytical procedures into current practices (Development, verification and transfer) to improve and maintain the perfomance of analytical procedures.
A fun, hands on practical component using a Statapult has been designed to demonstrate setting a target profile, investigating and controlling variables for the procedure and qualifying the procedure against the predetermined target.
Case studies are included for development of a new procedure, a method transfer and a verification of a compendial monograph procedure.
Although the material is based on HPLC for small molecules, the principles taught and the practical session, may also be applied to analytical procedures for large molecules.
This workshop is based on ICH Q8, Q9, Q10 and Q11 which have been adapted to suit analytical procedures. It also provides an update on the proposed new chapter ICHQ14 (Analytical Procedure Development), proposed updates to ICHQ2 (Analytical Validation) and the link for the new approach to analytical procedures cited in ICHQ12.
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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.