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Human Error Reduction Techniques for Floor Supervisors
Supervision plays a crucial role in Human Error Reduction and Control. Critical Factors like preparation, planning, scheduling, communication, among many others, will be discussed as part of this webinar. People make mistakes because they can; our systems allo ...
- Basic & Intermediate
- 90 Mins
- Ginette Collazo
- Jul 24, 2019
EN/IEC 62304 - Is your Medical Device Software Out of Compliance?
This course is essential for Medical Device and IVD companies interested in submitting software enabled medical Devices or Software as a Medical Device to the FDA for 510K approval. One of the biggest risks most company's face when submitting their device for ...
- Basic & Advanced
- 90 Mins
- Nancy Knettell
- Aug 02, 2019
Preparing a 21 CFR Part 11 QMS Software Validation Protocol
Review a company's software and Part 11 Verification and Validation System for major cGMP deficiencies. Address the FDA's newer and tougher regulatory stance, and how it addresses Part 11. Evaluating its elements against ISO 14971 and ICH Q9 for hazard analysi ...
- Intermediate
- 90 Mins
- John E. Lincoln
- Aug 07, 2019
Advertising and Promotional material compliance and review process
The information obtained will enable effectiveness and reliability of a review process for all materials. The webinar will address requirements for compliance within the US, “gray areas” that must be evaluated thoroughly, how to conduct a risk assessment, stra ...
- Basic & Intermediate
- 90 Mins
- Peggy J.Berry
- Aug 21, 2019
GDPR & California Consumer Privacy Act
During this session we will discuss GDPR & California Consumer Privacy Act (release 2020). Why it’s important and also, why are stricter rules and regulations being created. Is it with the public in mind?
- Basic & Intermediate
- 60 Mins
- Justin Muscolin
- Aug 27, 2019
Establishing Appropriate Quality Metrics and Key Performance Indicators (KPIs)
This course will discuss the importance of establishing metrics, how to distinguish Key Performance Indicators (KPIs), as well as, how to utilize those metrics to drive Quality Culture. Metrics for numerous departmental functional areas will be discussed; incl ...
- Basic & Intermediate
- 90 Mins
- Kelly Thomas
Strategies To Prevent Manufacture And Distribution Of Substandard Medications
Substandard product can exist even if the product itself is manufactured according to quality standards. Muhammad H. Zaman, in his book Bitter Pills, recalls his visit to a warehouse in Ghana that had no climate control, with temperatures in the warehouse reac ...
- Basic & Intermediate
- 90 Mins
- Michael Esposit
Effective Standard Operating Procedure (SOPs) Development
Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities. Currently, there is no guidance on how to develop or manage the SOP creation or the SOP quality system.
- Basic & Intermediate
- 60 Mins
- Danielle Delucy
FDA Internal Complaint Handling
The information obtained will enable preparation of effective internal systems for receiving, investigating and responding to product complaints during both the investigational and commercial stages.The webinar will address aspects of the review process, SOP p ...
- Intermediate
- 90 Mins
- Peggy J.Berry
Equipment Qualification and Process Validation
FDA current Good Manufacturing Practice (GMP) regulations require that all equipment be qualified and all manufacturing processes, including equipment cleaning processes, be validated. These qualifications and validations must be repeated if changes are made o ...
- Intermediate
- 90 Mins
- Loren Gelber