Pharmaceutical Regulatory Compliance Training - Live Webinars, Recordings & CDs

This program is specially designed for personnel in the Pharmaceutical and Biotechnology industries. This guidance provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.

Regulatory expectations for reporting in multi-company development and marketing programs.

The presentation covers the requirements of the Code of Federal Regulations for drugs, biologics, and medical devices, as well as key FDA Guidance Documents including the International Conference on Harmonization (ICH) E6. This program is essential for management of clinical trial sponsors and vendors.

This webinar will cover the concepts of critical cleaning, FDA requirements and cleaning validation. This webinar will enable one to approach issues surrounding cleaning validation.

This presentation will cover the regulations that apply to biologics in general as well as those that apply to members of the special classes. This webinar will be directed at workers with some experience who must now deal with the manufacturing of various biological products.

The following webinar will cover common CAPA problems across industries and how to avoid them. This webinar will provide valuable assistance to all regulated companies that need to have CAPA systems as mandated by the FDA.

This program will be helpful for those who must develop Risk Management processes for Pharmaceutical companies. This seminar will discuss how to make Risk Management an integral part of the processes of process design and manufacturing for the industry.

This webinar will provide valuable background for those who need to evaluate viral clearance data.

This Webinar will explain how to write a Cleaning Validation Master Plan. This webinar will discuss that what are the critical elements have to be considered when designing a cleaning validation program at a Pharma plant.

This session will introduce advanced control charting for multiple stream processes. We will also introduce control chart analysis and how to select the correct control chart and interpretation and reaction to control chart signals.

This statistical Design and Analysis of Experiments webinar will introduce DOE and process modeling.

This Viral Validation webinar provide information on potential viral contaminants and their risks, expectations of regulatory agencies, effective methods of viral inactivation/removal, and important considerations in the design of a viral validation.

This quality management system webinar will discuss the advantages and disadvantages of the virtual models and useful to those companies which, while not adopting the full virtual model, contract out many or most of their development activities.

This Designing Viral Clearance training discuss the design and implementation of a viral clearance study that includes appropriate viruses to model existing and emergent viral threats and evaluates the impact of potential fluctuations in processing.

This Method Validation training in drug development process will provide guidance in setting appropriate specifications, determining if the assay is validatable, and monitoring progress during the validation. This web seminar will address frequently observed issues and problems with method validations.

This process validation training for Pharmaceutical Manufacturers will allow your process validation program to be executed quickly and efficiently and will ensure that the process validation you perform supports a successful pre-approval inspection. Successful process validation of a cGMP pharmaceutical manufacturing process is essential for obtaining a commercial license.

This Radiopharmaceuticals training will set out guidance and advice for those interested in setting up or improving an existing facility. Radiopharmaceutical manufacture is starting to begin a new phase as FDG now has a product licence

This Medical device training will instruct on the regulatory requirements of personnel training, and establishment of a training program, including new employee training, methods of training, how to document training. To satisfy QSR and ISO 13485 requirements as well as produce quality products, companies must assure personnel are trained on their routine job practices as well as familiar with requirements that impact them.

This Pharmaceutical training will also provide attendees with the details and expectation stipulated in ISO 14644 series standards and FDA’s 2004 guidance document for aseptic processing. This seminar is designed to provide a thorough understanding of the principles applied to the design, qualification and operation of cleanrooms.

This program is designed for the medical device, IVD, and combination product industries This webinar will provide the core principles and practices needed to implement an effective and efficient CAPA process