Webinars

FDA: Mock and Pre-Approval Inspections (PAIs) - Part II

FDA: Mock and Pre-Approval Inspections (PAIs) - Part II

This course for pharmaceutical professionals provides the information they require, to prepare for and understand what will happen during a mock audit and during a Pre-Approval Inspection (PAI).
Cosmetic Manufacturing - How to Avoid FDA Audits

Cosmetic Manufacturing - How to Avoid FDA Audits

Although there are no official regs for cosmetic GMP’s, failure to maintain control of your operation can lead to severe regulatory consequences. You can avoid unwanted FDA oversight by maintaining cosmetic processes under control. One avoidable recall could result in a domino effect having tremendous negative impact on your organization.
Applying Six Sigma Downtime to Analytical and Bioanalytical Labs

Applying Six Sigma Downtime to Analytical and Bioanalytical Labs

Applying Six Sigma techniques to laboratory practices increases efficiency, decreases waste and improves morale. This presentation will demonstrate how applying DOWNTIME can help improve the efficiency of lab service and function.
FDA Regulations for Commercializing OTC Drug Products

FDA Regulations for Commercializing OTC Drug Products

The U.S. Food and Drug Administration’s is responsible for regulating the Over-the-Counter Drug market. In this webinar, attendees will learn what is required to market and sell an OTC drug in the U.S. It will provide information on what is an OTC drug, how they are regulated, the different types of products, how to read a Monograph, whether or not a certain ingredient can be used, the parts of a proper label, and a variety of other important requirements needed to be successful.
Strategies For Speeding Up Formulation Development

Strategies For Speeding Up Formulation Development

This webinar provides some practical and useful answers to the question: “What Strategies Should I Use to Speed Up Formulation Development?” A strategy based on QbD principles that have been proven to effectively and efficiently develop useful multi-component formulations is presented in this webinar. A critical goal is the creation of formulation understanding and design space that will consistently produce a product that meets specifications with minimal risk of failure. This strategy will be described and discussed along with several examples of its use.
MHRA Guidance during the COVID-19 Emergency: Drug Regulation

MHRA Guidance during the COVID-19 Emergency: Drug Regulation

In response to the global coronavirus pandemic, the UK’s MHRA has published guidance designed to protect the drug supply chain. The scope of the guidance is far-reaching (see below for details) and includes temporary changes to GMP and GDP expectations as well as some licensing arrangements.
Drug Manufacturing Inspection Part III

Drug Manufacturing Inspection Part III

Attend this course to prepare for and understand what will happen during a Drug Manufacturing Inspection for Surveillance Inspections. It will explain the FDA criteria to perform a For Cause Inspection.
Immunogenicity Of Biological Drugs: Why, How And What

Immunogenicity Of Biological Drugs: Why, How And What

The consequences of an immune response to biologicals, range from transient appearance of antibodies without any clinical significance to severe life-threatening conditions. Understanding why an immune response is generated, how to detect or predict its generation will help in designing products that will be efficacious and therapeutic.
Building a Compliant Laboratory - From Foundation to Business Excellence

Building a Compliant Laboratory - From Foundation to Business Excellence

Everyone struggles with getting their laboratory into compliance. Learn how to build a compliant laboratory from starting with a good foundation to implementing for Business Excellence. Dr. Husman’s presentation will walk you through the process and steps needed to ensure a compliant laboratory is built or rebuilt for business excellence.
SaaS/Cloud Risk-Based Validation With Time-Saving Templates

SaaS/Cloud Risk-Based Validation With Time-Saving Templates

This 21 CFR Part 11 compliance training will guide you through the requirements of Part 11 and will also explain its 3 primary areas: SOPs, product features and validation (10 step risk based approach).
FDA's Ambitious Regulation of Social Media

FDA's Ambitious Regulation of Social Media

FDA regulates advertising and promotion material as labeling. The legal definition of labeling covers just about anything that explicitly or implicitly conveys a message intended to affect a person’s behavior and decision outcomes. How FDA applies its legal tenants of false and misleading information or variations on that theme requires continual updating by FDA and constant re-evaluation by industry. Now the regulatory landscape involves other federal agencies and academic principles in psychology. It has become very complicated and will prove very costly if you knowingly or unknowing walk into one of FDA’s legal snares. This webinar will bring attendees up to speed so you are clearer about what is a problem, what is not a problem and what becomes a risk laden judgment call.
Reviewing Drug Product Batch Records

Reviewing Drug Product Batch Records

Batch record review is an important step in the release of a medicinal product. This webinar sets out the regulatory requirements for batch records and sets out a systematic approach for review. Trending of batch data is also discussed.
ISO 14971:2019 – What’s new in the updated standard?

ISO 14971:2019 – What’s new in the updated standard?

This webinar will benefit medical device companies planning to have a CE mark under the European Union Directive 93/42/EEC. We will discuss what is new in ISO 14971:2012 and help you avoid delays in obtaining or maintaining your CE mark for compliance to the Medical device Directive, EU Directive 93/42/EEC on Medical Devices.
Risk-Based Software V&V Per U.S. FDA, IEC 62304, GAMP 5 (Reg.) and ISO 14971

Risk-Based Software V&V Per U.S. FDA, IEC 62304, GAMP 5 (Reg.) and ISO 14971

This software verification and validation training will discuss how to develop / implement formal software Verification and Validation methods for devices, production and test equipment and electronic records / signatures / Part 11 to meet regulatory / cGMP expectations, reducing the risk of 483 observations and Warning Letters. US FDA, Several standards and industry recommendations will be described in this V&V methods.
FDA Inspection Readiness

FDA Inspection Readiness

Although an effective Quality System should always be inspection ready, many medical device companies make basic mistakes during inspections leading to 483s and even warning letters. This webinar will help you create an inspection readiness plan so you are well prepared for an FDA inspection. This webinar can help you manage inspections efficiently and effectively. You’ll learn about the FDA’s inspectional approach, focus areas, and what documents they will be asking for. A professional, polished, responsive approach sets a good tone for an inspection. You will learn how to present information about your quality system in the most competent and professional manner.
GMP Environmental Monitoring for Pharmaceutical Clean Rooms

GMP Environmental Monitoring for Pharmaceutical Clean Rooms

This webinar will discuss various US and international regulatory requirements, testing requirements for environmental monitoring program, current air and surface monitoring for measurement of no-viable particulate, microbial contamination, contamination due to personnel (gowning techniques and aseptic practices), ongoing monitoring practices with reference to sampling frequency, sampling locations and investigation of action level excursions and monitoring data.
Scheduling and Conduct of Good Pharmacovigilance Practice Audits

Scheduling and Conduct of Good Pharmacovigilance Practice Audits

This webinar is intended for the pharmaceutical industry and associated service providers. It will provide pharmacovigilance and quality assurance departments with an overview of regulatory requirements and expectations for Good Pharmacovigilance Practice audit programmes, with a focus on auditing of activities internal to an organisation as well as those contracted out to service providers and commercial partners, such as distributors and licence partners.
Risk-based Design Control - The New Paradigm for Medical Device Design

Risk-based Design Control - The New Paradigm for Medical Device Design

This webinar about risk-based design control reviews the FDA’s and ISO’s guidance and regulations and provides practical ways to implement a robust risk-based design control in your company. It shows you practical ways to simply work and hand and enough spend time on actual risk management and mitigation.
CGMP controlled Raw Materials

CGMP controlled Raw Materials

This webinar will help the attendee gain an understanding of the appropriate way to design the processing of all cGMP Controlled raw materials that are used for the manufacturing of drug product. The scope of this webinar applies to all cGMP controlled raw materials that are received, requiring testing, release and issuance of specifications. It also applies to the processing of changes and retiring of previously issued controlled raw materials specification within the product manufacturing process. cGMP Raw materials that are used for product manufacturing has to be released for use in the production process. Guidance will be given as to the steps that every drug product manufacturer should follow in order to process all incoming cGMP controlled raw materials which includes the release for use in the manufacturing of products.
The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory

The Use of Statistical Process Control (SPC) Using Control Charts to Maintain Compliance in the Laboratory

Attend this webinar to learn how to understand control charts and their underlying statistics, how to choose variables to monitor, how to maintain the records and to plan adjustments. There will be examples and walkthroughs of control chart implementation and use. A review of the relevant statistics will also be done. Why you should attend?

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