WEBINARS

 

Biotechnology Quality and Safety Regulatory Compliance Training - Live Webinars, Recordings & CDs

Proper Execution of Annual Product Reviews

webinar-speaker   Danielle DeLucy

webinar-time   60 Min

Product Id: 704993

This webinar will give a brief overview of the general procedure for the preparation and documentation of the Annual Product Quality Review and also focuses on the regulations and the regulatory requirements as per US and Europe.

Recording Available

* Per Attendee $299

 

Steam Sterilization Microbiology and Autoclave Performance Qualification

webinar-speaker   Danielle DeLucy

webinar-time   60 Min

Product Id: 705027

In this webinar, the steam sterilization mechanism will be described as it relates to bacterial cells and endospores. The process and key terminology are defined. Understanding these fundamentals is critical to develop a successful autoclave sterilization process.

Recording Available

* Per Attendee $299

 

An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (''HCT/Ps'') including Stem Cell-Based Drug Products for Human Use

webinar-speaker   Karl M. Nobert

webinar-time   90 Min

Product Id: 701927

This webinar will review FDA's regulatory oversight of stem cell-based products when used in humans and analyze its potential impact on the industry in the future. Learn FDA's criteria for marketing and promotion of stem cell-based products for therapeutic application.

Recording Available

* Per Attendee $399

 

Implementation and Management of GMP Data Integrity

webinar-speaker   Danielle DeLucy

webinar-time   90 Min

Product Id: 705029

Attend this webinar to learn the regulatory expectations for data integrity during CGMP inspections. The course will review examples of data integrity pitfalls, part 11 compliance data integrity issues, FDA citations related to data integrity. It will teach you how to improve data integrity in a laboratory environment.

Recording Available

* Per Attendee $299

 

Bioanalytical Methods Validation

webinar-speaker   Edward O Connor

webinar-time   60 Min

Product Id: 701769

This training on bio-analytical methods validation will help you to understand the FDA and EMA guidance for Instrumental, ligand binding and cell-based assays and also review of recent 483s impacting validation.

Recording Available

* Per Attendee $149

 

Making Data Driven Decisions using Statistical Hypothesis Testing

webinar-speaker   Steven Wachs

webinar-time   60 Min

Product Id: 704211

This training program will cover statistical hypothesis testing concepts including: null and alternate hypotheses, test statistics, p-values, confidence intervals, confidence levels, power, power curves, and sample sizes. Several types of hypothesis tests will be covered such as 1 and 2-sample means tests, tests of variances, and tests of proportions. Equivalence tests will also be discussed. The importance of selecting appropriate sample sizes will be stressed.

Recording Available

* Per Attendee $299

 

Understanding and Implementing a Technology Transfer Process

webinar-speaker   Steven Laurenz

webinar-time   60 Min

Product Id: 705031

This webinar will discuss the steps to guide the technology transfer for the successful implementation, ensures that products of the highest quality are delivered to the patients along with meeting the business demands of the company.

Recording Available

* Per Attendee $299

 

Objectionable Microorganisms in Biopharmaceutical Manufacturing

webinar-speaker   Carl Patterson

webinar-time   60 Min

Product Id: 705319

This webinar will discuss the regulations pertaining to objectionable microorganisms, agency expectations, methods to identify objectionable microorganisms, interpreting results, and controls to put into place.

Recording Available

* Per Attendee $249

 

Performing an Effective, Robust and Compliant Sterility Failure Investigation: How to Avoid Common Mistakes

webinar-speaker   Charity Ogunsanya

webinar-time   90 Min

Product Id: 703885

This training program will highlight mistakes often made when corrective and preventative actions are not clearly identified and applied during a manufactured product sterility test failure investigation because an ineffective investigational procedure and tool was used to conduct a sterility test failure investigation. The webinar will also illustrate how avoiding such common mistakes will ensure that these types of products meet the sterility requirements USP <71> and other regulatory guidelines applicable to finished products, bulk drug substance, raw materials or excipients.

Recording Available

* Per Attendee $299

 

4-Hr Virtual Training: How to Respond to an FDA Investigation

webinar-speaker   Joy McElroy

webinar-time   4 hrs

Product Id: 704549

This FDA investigation training program will deconstruct best practices for handling unannounced FDA visits, responding to a 483 or a warning letter, and the effect of an FDA investigation. The program will also discuss basic concepts that should be employed by everyone regulated by the FDA and define processes for preparing for FDA audits.

Recording Available

* Per Attendee $449

 

Automating Assays for Clinical Diagnostics

webinar-speaker   Todd Graham

webinar-time   60 Min

Product Id: 703268

This webinar on automating laboratory assays will teach you how to translate an assay that is performed manually to one that is fully automated, with high quality and with proper validation and quality assurance for regulatory purposes.

Recording Available

 

SOP's for Bioanalytical Methods Validation

webinar-speaker   Todd Graham

webinar-time   60 Min

Product Id: 704916

This webinar will help you learn how to validate bioanalytical methods. This session will teach you the pitfalls behind bioanalytical methods validation, allowing one to transition between assays with ease.

Recording Available

 

Quality Risk Management Overview for Pharma, Biopharma and Combination Products - ICH Q9/ISO 14971

webinar-speaker   Tanvir Mahmud

webinar-time   90 Min

Product Id: 702422

This 90-minute webinar will cover principles and provide examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. It will provide you with the knowledge and understanding needed to improve patient safety and also to prepare your organization for regulatory inspections.

Recording Available

* Per Attendee $299

 

CDISC Mapping 5: ADAM Models - ADSL, BDS and ADAE

webinar-speaker   Sunil Gupta

webinar-time   90 Min

Product Id: 704316

This training session is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. The program will provide effective and practical solutions to address real-world issues.

Recording Available

* Per Attendee $299

 

CDISC Mapping 4: SDTMs and ADAMs Examples (80%/20% Mapping Rule)

webinar-speaker   Sunil Gupta

webinar-time   90 Min

Product Id: 704313

This training program is intended for anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Through case study analysis, the course will examine best practices to provide thoughts and ideas to develop or improve the CDISC mapping system.

Recording Available

* Per Attendee $299

 

Understanding Aseptic Technique and Cleanroom Behavior

webinar-speaker   Danielle DeLucy

webinar-time   60 Min

Product Id: 704429

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.

Recording Available

* Per Attendee $299

 

Scale-Up, Cycle Transfer, and Maximum Throughput Capability for Lyophilized Products

webinar-speaker   J. Jeff Schwegman

webinar-time   90 Min

Product Id: 702893

This training on lyophilization cycles will cover the process of transferring and or scaling-up a lyophilization process to a larger or different freeze-dryer. It will discuss a methodical approach to understand the thermal properties of a product and simplify the scale-up or transfer process resulting in a consistent product being produced in any freeze-dryer.

Recording Available

* Per Attendee $299

 

Vendor Qualification - How to Design and Implement an Efficient and Compliant Vendor Program

webinar-speaker   Todd Graham

webinar-time   60 Min

Product Id: 703066

This webinar will tell you what you need to know to design a compliant vendor program, implement it throughout the organization, manage the necessary documentation and effectively communicate with vendors your requirements, needs and issues.

Recording Available

* Per Attendee $299

 

CDISC Mapping 3: Compare and Contrast SDTM and ADaM Steps

webinar-speaker   Sunil Gupta

webinar-time   90 Min

Product Id: 704302

This training program will assist anyone directly or indirectly responsible for the creation, content or validation of CDISC data sets, tables, and data lists used to support research, drug or medical device efficacy and safety in a regulatory submission. Professionals in the pharmaceutical, biotechnology and medical device industries who want to be Good Clinical Practices (GCP) compliant in relation to regulatory submission environment will benefit from this training. Effective and practical solutions to address real-world issues will be detailed.

Recording Available

* Per Attendee $299

 

Pre-Formulation and Formulation Development of Small and Large Molecules for a Lyophilized Product

webinar-speaker   J. Jeff Schwegman

webinar-time   90 Min

Product Id: 702305

This webinar on lyophilization technology will provide you the understanding physical properties of formulated products through the use of very specialized analytical techniques. Also attendees will learn pre-formulation assessment, pre-formulation studies including choosing an optimal solution pH and buffer system, solubility enhancement, controlling oxidation, and bulking agents.

Recording Available

* Per Attendee $249

 

 

 

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