Product Id: 706706
Validation is an important element of the Quality System Regulations and ISO 13485. This course will cover the validation essentials for medical device manufacturers. You’ll learn about what processes needed to be validated and what steps you need to take to validate processes. Validation is a powerful tool in understanding, optimizing, and controlling manufacturing processes. We’ll cover the essential steps of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.
15 / Jun / 2021 - Tuesday
Product Id: 704986
Creating a safety culture in the workplace takes time, patience, and is often a multi-year process. This training program will examine how organizations need to transition from the existing zero injury workplace culture to a more safety oriented culture. In the process, it will examine the pros and cons behind each process and also offer best practices to determine whether you are doing it right.
Product Id: 706561
As a “GxP” system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA’s CFR Part 11 guidance on ER/ES must be followed to assure data integrity is maintained. This webinar will focus on the efforts by FDA to modernize their own technology infrastructure, and what this means to industry. We will cover the Technology Modernization Action Plan (TMAP) that has been launched by FDA for this purpose and discuss specific actions that are planned and in progress.
Product Id: 700986
This session will include the requirements for all of the complaint handling responsibilities, which will include defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications. Also covered will be a discussion of what constitutes a complaint, and recommended practice on how to handle "non-complaint" feedback. Also covered will be the application of risk management to a complaint handling system, and a specific risk management system explained.
Product Id: 706638
Attendees will learn the FDA expectations when investigating out-of-specification and out-of-trend laboratory results.
John E Lincoln
Product Id: 706721
The rapid expansion and broad applicability of software functions / applications deployed on mobile or other general-purpose computing platforms has created concerns with industry and the US FDA. This has resulted in the FDA focusing on the subset of software functions dealing with medical issues which the Agency intends to apply its authority. What are these issues / software app claims, and how will this affect the medical device industry.
Diane L Dee
Product Id: 705542
Missteps in handling sensitive employee issues could result in your organization writing a check with a lot of zeros on it. How companies investigate potential misconduct can affect the company’s reputation as well as its bottom line. Cultural and generational diversity is changing the landscape of the US workforce. That diversity can become fuel for all types of litigation. Understanding how to effectively conduct workplace investigations can greatly reduce the chances of your organization being sued.
Product Id: 703028
This IRS regulatory compliance training will explain the TIN matching system best practices to eliminate form 1099 reporting errors. It will also provide you the tools to effectively handle B- Notices in order to avoid fines and penalties.
Janette Levey Frisch
Product Id: 705703
In this webinar, we will explore the challenges employers now face in managing employee marijuana use. We will, also discuss applicable laws (both statutes and cases) addressing this subject, analyze recent court cases. The laws, of course vary by state. You will receive an overview of where many of the different states are currently holding with respect to medical and recreational marijuana and employer’s rights and obligations.
Product Id: 705602
The FinCEN has issued substantial new AML requirements focused on a major expansion of Know Your Customer into what is now Customer Due Diligence, CDD. This webinar will present various aspects of the requirements.
Process for Performing a Vendor/Contract Audit: What Should be Considered and How to Plan, Perform and Report Results of a Vendor Audit
Product Id: 706219
Attend this webinar to learn about the different contract terms, different ways to determine the scope of the audit given contract terms and conditions, how to plan, perform and report results of a vendor audit.
CMO Supplier Quality Agreements - How to Comply with New FDA and EU Guidelines for Contract Drug Manufacturers
Product Id: 703476
This webinar will include a detailed discussion of Contract Manufacturing Organizations (CMO) Quality Agreement topics such as change control, documentation, facilities and equipment, lab controls, sub-contracting, etc. Attendees will learn how to comply with new FDA and EU guidelines for contract drug manufacturers.
Dr. Afsaneh Motamed Khorasani
Product Id: 705583
In this webinar, we will discuss the definition, purpose, importance of GDP, General rules of GDP, GDP as it applies to laboratory notebook documentation, US Pharmacopeia General Chapter <1029>, and introduction “Good Documentation Guidelines”. We will also briefly introduce you to the European Union (EU) GDP, and its enforcement along with some observation samples from FDA.
Product Id: 706101
Data integrity has been the subject of increasing scrutiny during pharmaceutical regulatory inspections in recent years. Chromatographic data systems have received particular attention because of the potential for data manipulation to produce fraudulent data or uncontrolled changes in processing parameters that compromise the comparability of results between runs. This webinar explains the intention behind data integrity regulations, sets out current expectations and suggests an approach to compliance based on sound science.
Product Id: 706560
This webinar will give you a clear structured overview and introduction, into the cybersecurity risk management in relation to the cybersecurity regulation in EU and US and its requirements in the EU and US.
Product Id: 706214
This webinar will discuss how to more effectively write and revise standard operating procedures (SOPs) with a focus on increasing operational efficiencies.
John E Lincoln
Product Id: 705877
This 60-minute session on master verification and validation planning will discuss the major cGMP deficiencies and "must have" elements from the U.S. FDA cGMP, ICH Q9 and ISO 14971 for hazard analysis and product risk management, and show how you can integrate these into a company's quality management system.
Product Id: 706722
Despite growing available information and training materials about the critical value of Software Asset Management, many organizations still find themselves unprepared for a software license compliance audit. A software license audit can cause severe disruption and takes time and resource away from business as usual. In this webinar, Dr. Davis will discuss the different approaches to achieving software license contracting compliance.
Ginette M Collazo
Product Id: 704107
This training program will offer attendees an understanding of human errors in GMP related environments, factors and causes, and control measures to be put in place to reduce the same.
Product Id: 705022
This webinar training pays for itself in terms of your firm's potential savings and detection of fraud. The training is designed to both prevent and detect fraud. We first teach you how to establish an administrative environment where fraud is less likely to occur. We’ll then examine Excel tools that are used by CPAs and Internal Auditors to detect fraud.