
Risk-based Approach to Biopharmaceutical Method Transfers
Jeffrey Staecker
60 Min
Product Id: 705049
This Webinar will discuss how non-compendial biopharmaceutical analytical method transfers can leverage a risk-based approach to address Quality and Regulator concerns. Method transfers using a statistical equivalence approach with tight criteria as frequently suggested by regulators makes it difficult to transfer methods and can result in a high transfer failure rate.

Interviewing and Hiring the Right People
Catherine Mattice Zundel
75 Min
Product Id: 704987
This training program will cover the interviewing and hiring process in six steps: understanding the organization’s culture, conducting a job analysis, developing behavior-based interview questions, recruitment strategies, interviewing and selection, and HR onboarding.

Compliance with Brexit's Impact on the Global Pharmaceutical industry
Laura Brown
60 Min
Product Id: 705047
Pharmaceutical companies will need to develop strategies for their drug programmes to deal with Brexit. This webinar will provide an essential understanding to help develop a strategy for managing Brexit.

Quality by Design
Heath Rushing
60 Min
Product Id: 705051
This training program will guide attendees in implementing QbD principles from discovery through product discontinuation. It will also illustrate applying statistics to set specifications and validate measurement systems (assays) and discuss utilizing risk management tools to identify and prioritize potential critical process parameters.

Sexual Harassment in the Age of Social Media - Investigation, Assessment & Prevention Strategies
U Harold Levy
60 Min
Product Id: 704976
Given the ease of receiving and viewing sexually explicit materials on cell phones, computers and social media, employers as well as employees should be concerned about preventing sexual harassment in the workplace. This workshop will focus on the issue of sexual harassment and how to prevent it in the workplace. It will provide an overview of sexual harassment, sex discrimination, its definition and the laws that prohibit it.

Reimbursement Requirements for Designing Innovative Devices
Tom Kramer
60 Min
Product Id: 704625
This training program will highlight key metrics needed to convince reimbursement panels of design compliance and discuss how best to implement practices in your development process that ensure acceptance by reimbursement groups.

How to prepare a 510(k) FDA Submission
Edwin Waldbusser
60 Min
Product Id: 705024
This 510(k) training will discuss the submission process and the contents required by the FDA for a successful 510(k) submission.

TSCA Reform - Immediate Actions Required
Rose Passarella
60 Min
Product Id: 705036
This webinar will provide an overview of the new law and major changes to Toxic Substances Control Act (TSCA). All chemical stakeholders doing business in the U.S. will need to understand the fundamental shifts in requirements, the new concepts and approaches that are introduced by the law, and the timetable that the U.S. Environmental Protection Agency (EPA) must follow in implementing the new law.

Audits - Seven reasons they don't work
Susanne Manz
90 Min
Product Id: 705042
Continuous Improvement starts with awareness of issues and opportunities. And without an effective internal audit program, management lacks awareness of the issues within their quality system. Management is blind to the gaps in the quality system and the risk that poses for the company. Even worse, management is blind to the impact on product quality and risk to the customer. This webinar will highlight red-flags and ways reduce compliance and quality risk.

ISO 45001 - Migration Essentials – Parts 1, 2 and 3
Michael Aust
180 Min
Product Id: 705102
This three-part series ISO 45001 Migration Essentials webinar will take a closer look at the safety management system and ISO 45001. The series will provide an overview of the updated concept of ISO 45001, review its structure, and offer a comparative analysis of OHSAS 18001:2007 and ISO 45001. The webinar instructor will take attendees through a three year mitigation process for organizations already 18001 certified.

Phase I First-in-Man Studies: What is Special About How and Where These Trials are Conducted?
Charles H Pierce
90 Min
Product Id: 704842
This webinar will discuss the expectations of Phase 1 'First-in-Man' clinical studies, contrast the testing of pharmacokinetics and pharmacodynamics, differentiate safety testing in Phase 1 and 3 and describe the process of establishing the starting dose.

Ethical Dilemmas in Food Policy
Darin Detwiler
90 Min
Product Id: 705034
This webinar sheds light on the changes in the political, economic and judicial landscape of the food industry. Landmark food industry events over the last two decades highlight the evolution of the challenges and consequences related to ethical dilemmas in the food industry. This webinar covers the elements of food systems, economics of failure, true burden of disease, case studies from industry and regulatory agencies.

OSHA Recordkeeping for 2017: Beyond the OSHA 300 Summary
David A Casavant
90 Min
Product Id: 703492
This webinar will focus on the OSHA recordkeeping requirements. Attendees will learn how to ensure compliance with these regulations and avoid OSHA citations and fines.

7 Pillars of Implementing Zero Landfill Status
Michael Aust
60 Min
Product Id: 704889
This webinar training will discuss the employee and employer roles and responsibilities of achieving and maintaining zero landfill status by reducing environmental footprints. The instructor will explain the seven pillars of zero landfill and how to implement environmental sustainability through waste diversion.

Moving FDA Boundaries for Direct-to-Consumer Advertising
Casper Uldriks
90 Min
Product Id: 705033
FDA encourages companies that offer DTC advertising to include accurate information in their ads. Through a comprehensive surveillance and enforcement program, the agency ensures that consumers are not misled or deceived by advertisements that violate the law. This webinar will bring attendees up to speed so you are clearer about when DTC advertising makes you ripe for legal picking by the FDA.

Employment and Labor Laws With Respect to Social Networking: Understanding the Cause and Effect Relationship
Susan Fahey Desmond
90 Min
Product Id: 705037
Every company will find at some point that it will have a problem that arises from an employee’s use of social networking sites. This training program will discuss the legal implications behind improper handling of social networking issues at the workplace, the standpoint of regulatory agencies, and drafting policies to address these concerns.

Perceptions of The Health Risks of Cosmetics, and What it means to Their Regulation
Rob Ross Fichtner
90 Min
Product Id: 704955
This webinar will discuss some of the major issues in the regulation of cosmetics. Upon completion of the session attendees will learn how regulators regulate cosmetics compared to other categories, fine line between cosmetics and drugs, and future directions for cosmetic regulations.

How the Food Safety Modernization Act Affects USDA Regulated Facilities
Derrick Swint
90 Min
Product Id: 705032
This FSMA webinar will outline key objectives for the meat and poultry industry to better understand what steps must be taken by food producers in this sector to meet, and preferably exceed, all relevant standards and regulations of the Food Safety Modernization Act (FSMA).

Getting the Best from Your Performance Appraisal
Meloney Sallie Dosunmu
90 Min
Product Id: 705040
This training program will describe the key components of a performance management system. It will also highlight key strategies for engaging employees in the success of the business and discuss developing measurable performance goals.

OSHA's Famous Top 10 List of Citations: General Industry and Construction Industry Standards
Michael Aust
60 Min
Product Id: 704216
This training program will review OSHA’s top 10 list of citations for general industry (29CFR1910) and construction industry (29CFR1926) - FY 2015. It will explain best practices to stay ahead of OSHA enforcement actions.