Pharmaceutical
How to Ace Your Investigational New Drug Application: Prevent Clinical Holds
The requirements for an IND submission can be complicated and can be hard to understand. Commercial IND applications must be submitted through the FDA’s Electronic Submissions Gateway, while Research IND applications can be submitted via CDER NextGen Portal. Casting aside the technical jargon and interpreting the regulations in 21 CFR 312, what does the road ahead of you look like? It is worth stating upfro..
How to conduct Annual Product Reviews to achieve GMP Compliance
This webinar covered:Cost of qualityWhat is Quality Management all about?Tools for Continuous Quality ImprovementDiscussion of what to do when major quality problems are foundLearning ObjectivesWhat are the components of a proper Quality Management System?What it means to build a “culture of quality” that reaches the whole organization?How you can effectively collaborate on quality management while keeping ..
Understanding and Implementing a Quality by Design Program
The benefits of applying the QbD principles in the pharmaceutical industry have been well advertised. Most important are the direct benefits to our primary customer; the patient. Per Janet Woodcock M.D. Director, Center for Drug Evaluation and Research (CDER), Food and Drug Administration “All products are designed and developed to be of high quality; QbD provides a structured framework for developing, docu..
Stability Testing of Pharmaceutical Products from Regulatory Perspective
This webinar gives fundamental knowledge of stability testing requirements for establishing storage conditions and the expiration of pharmaceutical products.Stability data form an important element of pharmaceutical regulatory submissions. This webinar will provide participants with the necessary knowledge to design and conduct stability studies that meet regulatory requirements. Also, they will be able to ..
Understanding and Implementing a Technology Transfer Process
Successful transfer of pharmaceutical products and their processes is critical to the successful launch. Its success ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company. However execution of that transfer is complex involving the interactions of many disciplines across an organization. It depends both on the careful development, m..
Achieving Success and Compliance in the Supply Chain
The Supply chain is a system of organizations, people, activities, information, and resources involved in moving a product or service from supplier to customer. Supply chain activities involve the transformation of natural resources, raw materials, and components into a finished product that is delivered to the end customer.Areas CoveredWhat is a supply chain?Examples of basic supply chainSupply Chain Manag..
Computer System Validation (CSV) And Software Testing: Applying An Agile Methodology vs. Waterfall For FDA-Regulated Computer Systems And Software
Advancements in technology have forced organizations to rethink business models. Once controlled and orderly, these organizations are now more chaotic and complex, serving patients and customers that are better informed and with higher expectations than ever before. Work practices and tools must change to meet these challenges. The approach to developing software, performing validation, and maintaining a sy..
Effective Batch Record Review
Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance.A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production an..
Equipment Qualification and Validation of Processes
The course will examine best practices to provide thoughts and ideas to develop or improve the performance of your current system. This course will provide discussion on European and FDA regulations as well as global harmonization and expectations. The course will also cover specific aspects of equipment qualification and process validation, such as protocol writing, methodology and performance, report writ..
How to Write and Manage a Change Control System
This webinar will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution and final implementation. The importance of proper planning, critical thinking skills, and co-ordination of all change activities will also be discussed.Areas CoveredIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrate how..
Implementing a Change Control Quality System Successfully
This course will help attendees understand the fundamental change control steps and processes. It will focus on change proposals, assessments, execution, and final implementation. The importance of proper planning, critical thinking skills, and coordination of all change activities will also be discussed.Learning ObjectiveIdentify what constitutes a changeLearn how to properly categorize a changeDemonstrate..
2019 Update: How to Write Effective SOPs for FDA inspection & Regulatory Compliance
This webinar will instruct the participant on how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is concise, reproducible and easy to follow. It will begin with a strategic view of SOPs in a company and how SOPs can help streamline operations in addition to ensuring regulatory compliance. This will be followed by an explanation on how to get from..
5S for Operators
Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. One method to improve productivity and reduce human error is the “5S Method”. This webinar is intended to provide you with practical knowledge on how to keep your workplace cleaner, safer, simpler..
Adverse Event Reporting Rules for Drugs, Dietary Supplements & Cosmetics
This event will cover everything you need to know about how to Define a Serious Adverse Event and FDA’s Serious Adverse Event (SAE) reporting requirements for OTC Drugs, Cosmetics, and Dietary Supplements. It will also cover what to expect regarding reporting changes for Cosmetics when the Personal Care Products Safety Act is passed.All OTC drugs and Dietary Supplements are required to report Serious Advers..
Advertising and Promotional Material Compliance and Review Process
The information obtained will enable the effectiveness and reliability of a review process for all materials. The webinar will address requirements for compliance within the US, “gray areas” that must be evaluated thoroughly, how to conduct a risk assessment, strategies for mitigating risks, and making challenging decisions. You will hear about the opportunities for input from regulatory agencies at critica..