Training Doyens

Drugs produced in the pharmaceutical industry go through extensive quality controls to ensure a level of safety for the consumer or patient and yet when we talk about the process and quality controls in medical cannabis production, there is still a lot to learn. Our upcoming webinar discusses the recent federal government position on ending cannabis prohibition nationwide and what the regulations mean for GMP regulated industries. The webinar covers the following key areas: ·          HR policies and the new cannabis era (labor law challenges) ·          Common quality failures and threats ·          Challenges with the regulation of plant-based product LEARNING OBJECTIVES • Recent federal government position on ending Cannabis prohibition nationwide • FDA position on CBD and other cannabis derived products • Background from a regulatory standpoin...

OVERVIEW FDA requires that all computer systems used to produce, manage and report on GxP (GMP, GLC, GCP) related products be validated and maintained in accordance with specific rules. You’ll learn all about how to create and maintain good FDA-compliant documentation using a strategic approach based on System Development Life Cycle (SDLC) Methodologies. The webinar will leave you with the information needed to plan, execute and document a computer system validation effort that meets FDA compliance standards .  You will learn about what must be done to ensure the system remains in a validated state.  In addition, you’ll learn about the various computer system validation deliverables and how to document them through the entire process. WHY SHOULD YOU ATTEND This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodologies when validating computer systems subject to FDA regulato...

GMP Audits Talking of product safety, the goods that require maximum scrutiny are health, food and beauty products. To make sure that the suppliers and manufacturers belonging to this sector are maintaining the standards set by government agencies, GMP audits are necessary. It’s important to ensure that the manufacturing process is well defined and controlled and the product matches the predefined specifications. In case alterations in the procedures affect the product, there must be appropriate procedure for analyzing the product for its quality. And, if the quality gets compromised, the product must be discarded. Customers should receive the product with clear and understandable instructions.  GMP audits ensure that all the procedures in the supply and manufacturing units  are in accordance with the recommended practices and the products meet the quality specifications. GMP GMP is an acronym for Good Manufacturing Practices and refers to a set of practices required...

OVERVIEW FDA requires that all documentation related to GxP (GMP, GLC, GCP) products be created and maintained in accordance with specific rules. From the color of the ink used to the FDA labeling requirements, you’ll learn all about how to create and maintain good FDA-compliant documentation. The webinar will leave you with the information needed to create and maintain good documentation that meets FDA compliance standards. You will learn about what must be done and what must not be done. In addition, you’ll learn about the validation deliverables for computer systems regulated by FDA and how to document them through the entire process. WHY SHOULD YOU ATTEND You should attend this webinar if you are responsible for any FDA-regulated data and/or records.  All documents need to be created and maintained in accordance with FDA guidelines for good documentation to avoid any issues during an inspection or audit.  You will also benefit from learning about the guidelines...

OVERVIEW This webinar will review the current regulations, guidancedocuments for GMP Documentation in detail. Regulatory strategies and logistical considerations for early development stage product, including vendor selection and management, stability, labelling, and documentation requirements will also be reviewed and explored. WHY SHOULD YOU ATTEND Attend this webinar so that you may understand differences between GMP requirements for early and later stage clinical development. Explore and discuss ways to develop and implement strategies for your GMP documentation. Good Manufacturing Practices Training AREAS COVERED IND and NDA Content and Format for CMC Information Vendor Selection and Management for Outsourcing early Manufacturing Raw Material Selections and Considerations Required SOPs and Documentation LEARNING OBJECTIVES Learn the rules and regulations governing GMP Documentation. Also learn about the development and implementation of strategies ...