Webinars

Sterilization of Pharmaceutical Products and Medical Devices

Sterilization of Pharmaceutical Products and Medical Devices

This webinar will discuss in detail the methods of sterilization to be used on medical devices and pharmaceutical products including advantages and disadvantages of each method. Also attendees will understand the regulations pertaining to sterilization of products that will help to decide with method to use for their product. Validation of each sterilization method will be discussed and how best to prove to a regulatory body the products being treated are considered sterile.
Technical Writing in the Pharmaceutical Industry

Technical Writing in the Pharmaceutical Industry

In this webinar, learn how to write technical documents in a highly specialized, highly regulated field like the pharmaceutical industry. It will teach you the techniques that that are easy to understand and help in creating high quality documents with the least amount of problems.
Basic Clean Room Technology, Operation and Contamination Control in a Nutshell

Basic Clean Room Technology, Operation and Contamination Control in a Nutshell

Attend this webinar to understand the Clean Room regulations, design, classification, sources and types of particles. Learn how to create a common ground between these varying regulations and requirements. It will discuss the types of micro-organisms, routine monitoring processes, and typical mitigation steps to effective contamination control.
Pharmacokinetic Principles in Preclinical Safety Assessment

Pharmacokinetic Principles in Preclinical Safety Assessment

This webinar will describe the basic principles of pharmacokinetics, with specific emphasis on issues that can impact toxicokinetics in preclinical safety assessment studies. It will highlight methods for the optimization of physicochemical properties in the discovery and development of oral drug candidates and explore some of the preclinical methods used to select first in human (FIH) doses.
Surviving an FDA Sponsor Inspection - Training for Success

Surviving an FDA Sponsor Inspection - Training for Success

This training program will review a case study derived from actual inspections wherein FDA performed a sponsor site inspection having already audited three of the investigator sites. FDA was aware from these site audits of potential serious noncompliance issues. The course will also discuss Sponsor/CRO/investigator relationship issues from these three site audits.
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.
Process Validation - Overview of Why and How

Process Validation - Overview of Why and How

This webinar will provide understanding of FDA and ISO 13485 requirements for process validation and how to implement them.
Health Canada Medical Device Regulations (SOR/98-202)

Health Canada Medical Device Regulations (SOR/98-202)

Attend this webinar to get an overview of the Health Canada Medical Devices Regulations and its requirements. Also, get guidance on how to approach MDEL and Device Licensing, Renewals and Costs.
Statistical Justification for Using Small Sample Sizes and only 3 Lots in Process or Product Validation

Statistical Justification for Using Small Sample Sizes and only 3 Lots in Process or Product Validation

In this webinar attendees will learn a statistically valid method for justification of small sample sizes for use in product or process validation studies (e.g. performed during design verification phase of design control). A different method will be explained for how to statistically justify the number of lots or batches used in such studies, a number that can be as low as 3.
Japan: Regulatory Compliance Requirements for Life Science Products

Japan: Regulatory Compliance Requirements for Life Science Products

This training on Japanese regulatory compliance requirements will explain the country's regulations and processes (including clinical trials, filings, etc.) and use real world experiences to show how compliance issues are culturally handled for life science products in Japan.
Human Error Reduction Techniques for Floor Supervisors

Human Error Reduction Techniques for Floor Supervisors

Attend this course to gain practical approaches for supervision on the floor, strategies to get your group in sync and approach issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.
Guideline to Aseptic Technique and Clean Room Behavior

Guideline to Aseptic Technique and Clean Room Behavior

This training program will discuss how, in sterile compounding, aseptic technique is contributing to the prevention of microbiological contamination. It provides sterility, safety, and efficacy to the sterile product, especially various injections for patients. In this course, cleaning, gowning and proper methods of contamination control will be reviewed along with why clean rooms are designed the way they are.
HIPAA Gap Analysis, Risk Assessment and Risk Analysis - Finding and Managing Risks to Protected Health Information

HIPAA Gap Analysis, Risk Assessment and Risk Analysis - Finding and Managing Risks to Protected Health Information

This training on HIPAA compliance will teach the attendees how to examine their security policies, practices, and risk issues to find and fill any gaps in the documentation that is required by the HIPAA rules to show compliance, survive audits, and avoid enforcement action.
The Impact of ICH E6 R2

The Impact of ICH E6 R2

The updated GCP ICH E6 (R2) Addendum is having an overall impact. This webinar explores what this means for you, your company and selected vendors.
Combination Drug/Device Products CGMPs - Final Rule

Combination Drug/Device Products CGMPs - Final Rule

This training on combination product regulations will evaluate the chief areas of concern or change in the new CGMP requirements for combination products, 21 CFR Part 4, and clarify many of the issues and questions that arise involving combination products.

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