Yes, It's Possible! Tools for Concurrently Enhancing Compliance, Knowledge Transfer and Process Efficiency
Mike Kent
60 Min
Product Id: 706347
This webinar will illustrate a set of unique tools that simultaneously address challenges of improving awareness, accessibility and compliance with process-related information. Learn how to construct solutions that people across your organization can use to better understand how processes work and how their role fits in, all in ways that complement your existing procedures and document structure. You may also find these tools useful when performing investigations, identifying and mitigating potential risks, and describing a process to a regulatory inspector.
Brazilian Regulatory System for FDA Regulated Industry: Pack of 10 Training Courses
Robert J Russell,Eliana Silva de Moraes,Juan M Campos
16 Hrs
Product Id: 706488
Care of the LGBT Patient and Their Families: Policies, Procedures & Practices to Ensure Quality Care and Reduce Liability
Dr. Susan Strauss
75 Min
Product Id: 704699
This training program will list and enumerate relevant laws, regulations and standards required for health equity and patient-centered care of LGBT patients. It will discuss opportunities to collect LGBT–relevant data and information during the healthcare encounter and help chart strategic community outreach efforts to the LGBT population.
The Top Twenty Standards of Internal Control for a Corporation
Chris Doxey
60 Min
Product Id: 706042
Attend this webinar to learn the best practices of internal control and top twenty internal controls standard roles and responsibilities to detect and prevent fraud. Also attendees will learn top three critical corporate controls and why they are the foundation of any internal controls program.
Import Basics to Avoid Detention
Casper Uldriks
60 Min
Product Id: 706358
The webinar will cover requirements for all imported FDA regulated products. Topics covered include required information for FDA’s “Predict” screening program for entry, U.S. Customs Required Information (ACE) program, Harmonized Tariff Schedule, Affirmation of Compliance, and Export Certificate Denial.
Drug Master Files (DMFs) - Understanding and Meeting Your Global Regulatory and Processing Responsibilities
Robert J Russell
90 Min
Product Id: 701367
This DMFs (Drug Master File) training will discuss the current review and enforcement climate within FDA and the manner in which drug master files (DMFs) are reviewed by FDA personnel. Besides the US, the use of DMFs in the EU, Canada and Australia will also be discussed. Similarities and differences to the U.S. system will be highlighted.
How to Think Like a Crook - Money Laundering Prevention
Doug Keipper
60 Min
Product Id: 702770
This anti-money laundering training will describe the reasons and methods of money laundering in financial institutions. This will help attendees to protect themselves from regulatory risk by establishing an effective anti-money laundering system within their financial institution.
The General Data Protection Regulations and its Impact on Recruiting
Greg Chartier
90 Min
Product Id: 706426
Recruitment and GDPR are very closely tied since HR managers handle large volumes of candidate data during the hiring and firing processes. Given that infringement can lead to fines of up to 4% of annual worldwide turnover or €20 million, companies need to assess how the GDPR affects their organization. Attend this webinar to learn the new obligations to data processors and data controllers, including those based outside the EU.
FDA Regulatory Inspection and Audit Training: Pack of 6 Training Courses
Susanne Manz,Joy McElroy,Charles H Paul,Loren Gelber,Martin Lessem,Stephen Schwartz
7 Hrs
Product Id: 706482
Pharmaceutical Data Integrity Success Training Kit - Pack of 8 Training Courses
Gregory Martin,Kelly Thomas,Mark Powell,Ron Snee
11 Hrs
Product Id: 706481
Overcoming Obstacles of The Canadian Drug Regulatory Landscape
Susanne Picard
60 Min
Product Id: 706188
The Canadian Drug Approval Process is misunderstood by many and considered harsh by some. We will explore reasons why the Canadian market should not be overlooked and the benefits of including Canada in strategic drug development initiatives. We will share insights and practical examples that facilitate a positive, proactive and transparent interaction with Health Canada, and provide strategies for avoiding obstacles and managing them efficiently should they occur.
Validation of HPLC/UPLC Methodologies
John Fetzer
60 Min
Product Id: 705291
This training program will cover in detail the key elements of HPLC and UPLC method validation to ensure compliance with FDA GLP and ISO 17025 requirements.
Coronavirus: Health and Business Considerations
William Levinson
Product Id: 706434
The coronavirus outbreak has caused thousands of deaths around the world along with extensive economic disruption. China has issued several overt threats to disrupt U.S. supply chains, and the stock market is in turmoil. This presentation will provide information on how organizations can position themselves to handle the disruption and even realize opportunities for improved performance as a result.
Human Error Prevention Training Kit
Ginette M Collazo,Tom Kramer,John E Lincoln
10 Hrs
Product Id: 706472
Change Management - Managing Effective Change and Eliminating Unwanted Changes
David Husman
90 Min
Product Id: 706420
Change Management is one of the most critical quality systems a company can have. Well managed systems are effective in implementing desired changes and preventing unwanted modifications to validated processes. This webinar will discuss the requirements for change management, the steps for effective change management and the actions companies can take to ensure unwanted changes do not occur in their operations.
Beyond the Box-Checking: Strategies for Diversifying Your Ongoing GMP Training
Mike Kent
60 Min
Product Id: 706329
This webinar will illustrate ways to take your ongoing or refresher GMP training to well beyond recycling existing content, regardless of your training budget or available resources. By asking a few simple questions of key stakeholders, and tapping into your already creative process, annual GMP training can start to become more than just something everyone has to complete. Come away with a plan to take your program beyond a year-end box-checking exercise and into a resource that people flock towards.
Global Food Additive Regulation Review: Headwinds and Opportunities
Carolyn Fisher
90 Min
Product Id: 706290
This webinar will start with a general background about global regulations and then go into detail about specific food additives and how the regulations vary in specific international, regional regulatory and country regulatory documents.
PAT (Process Analytical Technology): An FDA and Industry Effort
Nissan Cohen
90 Min
Product Id: 706370
Process Analytical Technology was released by the FDA as a 21st century guideline in September 2004. This guidance was released to help the pharmaceutical industry with real-time release, process understanding, and using the process to ensure all CPPs and CQAs meet compliance, URS, and SOPs. The use of PAT can alleviate strenuous validation procedures by using the process as the function of validation.
Basic Laboratory Skills
Mark Powell
60 Min
Product Id: 706286
Accurate measurement of weight and correct use of volumetric apparatus are prerequisites for valid analytical measurement. This webinar covers the quality-critical aspects of both. It is intended for new starters in industrial analytical laboratories or for other staff who would benefit from refresher training.
Human Centric Change Management
Madonna Swanson
60 Min
Product Id: 706388
Change is difficult. At the core of all change is human nature and human nature is as diverse as each individual. Learn proven techniques that enable your transformation to not only be effective, but embraced by the diverse individuals in your organization.