GMP Environmental Monitoring for Pharmaceutical Clean Rooms

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 705783

This webinar will discuss various US and international regulatory requirements, testing requirements for environmental monitoring program, current air and surface monitoring for measurement of no-viable particulate, microbial contamination, contamination due to personnel (gowning techniques and aseptic practices), ongoing monitoring practices with reference to sampling frequency, sampling locations and investigation of action level excursions and monitoring data.

7 / Oct / 2024 - Monday

* Per Attendee $199

 

Good Clinical Practice (GCP) Basics for GMP Experts

webinar-speaker   David L Chesney

webinar-time   90 Min

Product Id: 706991

This webinar presents an introduction to fundamental GCP concepts for personnel who are experienced in GMP but new to the GCP topic. It is designed to help adapt principles learned in a GMP context to GCP operations, pointing out the similarities and differences between Quality Assurance management in each of these disciplines.

9 / Oct / 2024 - Wednesday

* Per Attendee $199

 

Finished Pharmaceuticals CGMPs

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706990

This webinar is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of finished pharmaceuticals under an appropriate system for managing quality. It is also intended to help ensure that The final drug product meets the quality and purity characteristics that they purport, or are represented, to possess.

9 / Oct / 2024 - Wednesday

* Per Attendee $199

 

Precision Tools for Error Reduction: Strategies and Implementation Techniques

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 704364

This training program will analyze the factors and causes behind human errors. It will define the process to manage human error deviations and participants will learn about human error measurement. The program will also discuss tools for measurement and Key Performance Indicators (KPIs).

16 / Oct / 2024 - Wednesday

* Per Attendee $199

 

Process Capability for Normal and Non-Normal Data (Focus: Process Stability, Capability and Cp, Cpk, Pp, Ppk, Cpm)

webinar-speaker   Steven Wachs

webinar-time   75 Min

Product Id: 705020

This webinar discusses methods for estimating process capability for both normal and non-normal data. Methods include estimating the proportion of defective products that may be produced as well as the calculation and use of common process capability indices (e.g. Cpk and Ppk). Process Capability assessments are discussed in the overall context of quality improvement/management.

23 / Oct / 2024 - Wednesday

* Per Attendee $199

 

US, EU and Japan GMP Requirements: Practical ICH Area Differences, Healthcare Authority Inspection Focus

webinar-speaker   Robert J Russell

webinar-time   90 Min

Product Id: 702029

This ICH GMP 90-minute webinar will provide your company the opportunity for comprehensive understanding of ICH Drug / Biologic GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan). It will cover the key areas of how ICH was established, it’s goals and objectives, expectations of the healthcare authorities involved and practical differences that you will experience in a GMP inspection of a facility by FDA, an EU Competent Authority or PMDA.

25 / Oct / 2024 - Friday

* Per Attendee $199

 

IRB Submissions Reviews and Approvals

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706992

To establish that a drug or device is safe and effective, tests are required. There are many preliminary tests, including lab tests, standards, guidances, etc. Finally the product must be tried out on humans / patients in a tightly controlled environment. The clinical site(s) IRB Review is and FDA requirement and crucial to obtaining a site(s).

5 / Nov / 2024 - Tuesday

* Per Attendee $199

 

FDA Bioresearch Monitoring Inspection Program 2024

webinar-speaker   David L Chesney

webinar-time   90 Min

Product Id: 706994

This webinar presents a survey of the FDA’s Bioresearch Monitoring Program, a series of FDA inspection programs covering regulatory inspections by the FDA of clinical trial sites, sponsors and Clinical Research Organizations, nonclinical testing laboratories, Institutional Review Boards (IRBs) and post marketing adverse event reporting requirements.

6 / Nov / 2024 - Wednesday

* Per Attendee $199

 

Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 703590

This webinar will take you through the primary sources of compressed air contamination. It will also detail GMP standards and requirements pertaining to compressed air quality.

11 / Nov / 2024 - Monday

* Per Attendee $199

 

Good Documentation Guideline (Chapter <1029> USP)

webinar-speaker   Dr. Afsaneh Motamed Khorasani

webinar-time   60 Min

Product Id: 705130

This webinar will familiarize participants with USP Chapter <1029> on good documentation guidelines. This session will wrap up the general concept and will provide information as to what needs to be documented in certain records.

13 / Nov / 2024 - Wednesday

* Per Attendee $199

 

Decision-Making and Human Error Prevention

webinar-speaker   Ginette M Collazo

webinar-time   90 Min

Product Id: 706986

Embark on a transformative journey to enhance your decision-making skills and fortify your ability to prevent human errors with our comprehensive course on "Decision-Making and Human Error Prevention." In today's complex and fast-paced world, the ability to make sound decisions and minimize the risk of human error is crucial across various professional domains.

3 / Dec / 2024 - Tuesday

* Per Attendee $199

 

Installation and Qualification of the Packaging Lines

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706996

Both the U.S. FDA and EU's MDR expect documented risk-based IQ, OQ, an PQs of medical packaging lines under U.S. FDA cGMP, EU MRD, ICH Q7 and Q9 and ISO 14971

3 / Dec / 2024 - Tuesday

* Per Attendee $199

 

Fundamentals of Good Clinical Practice

webinar-speaker   David L Chesney

webinar-time   90 Min

Product Id: 706997

This webinar introduces the concept of Good Clinical Practice (GCP), primarily from a US perspective. The webinar presents an overview of the FDA’s GCP regulations for drugs and medical devices. It also summarizes the key objectives of GCP and the responsibilities of Sponsors of clinical trials and site level clinical investigators.

5 / Dec / 2024 - Thursday

* Per Attendee $199

 

HVAC and GMP Environmental Control - for Pharmaceutical Cleanrooms

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 703831

Environmental control of pharmaceutical cleanrooms is essential to the manufacture of a quality product. Control of such conditions as airborne particulate, microorganisms, temperature, humidity, differential pressure, airflow, air velocity and personnel is crucial to protect the product from contamination. Therefore, the design, validation and ongoing monitoring of a cleanroom HVAC system are necessary to assure the quality and safety of the pharmaceutical product. This training program will offer attendees a proper understanding of the cleanroom environment and its testing requirements according to international regulatory standards from a compliance perspective.

10 / Dec / 2024 - Tuesday

* Per Attendee $199

 

Gaining and Re-establishing Control of Your Cleanroom

webinar-speaker   Joy McElroy

webinar-time   60 Min

Product Id: 705317

This webinar will focus on the critical steps in starting up a new cleanroom operation and releasing it for manufacturing. It includes a case study-based approach to dealing with excursion events and establishing control of the cleanroom after a worst case event.

Recording Available

* Per Attendee $249

 

Technical Writing for the Pharmaceutical, Medical Device and Biotech Industries

webinar-speaker   Joy McElroy

webinar-time   120 Min

Product Id: 704531

This technical writing training program will offer attendees an understanding of how the reporting process supports products in research, development, and in the marketplace. This virtual session will highlight the mandates for documentation set forth by the regulators, such as the FDA, the ISO, and other governing bodies. The program will train attendees on effectively reviewing and revising documents and assessing your audience, in effect producing effective written correspondence.

Recording Available

* Per Attendee $299

 

Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

webinar-speaker   Roger Cowan

webinar-time   60 Min

Product Id: 703727

It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will offer attendees a comprehensive understanding of the same while emphasizing the different types of sterilizing filtration available and their application to your particular system. For instance, the application of sterile filtration to use-point compressed air will be discussed in detail.

Recording Available

* Per Attendee $249

 

Understanding and Preparing for FDA Pharmaceutical Inspections

webinar-speaker   Michael Ferrante

webinar-time   90 min

Product Id: 706965

This webinar will focus on the current trends in FDA Inspections and guidelines and how this information can be utilized to provide a foundation for compliance with the latest quality and regulatory requirements. Attendees will learn how to proactively prepare for an inspection.

Recording Available

* Per Attendee $249

 

US FDA's Cybersecurity and NIST Framework Requirementsfor Networks

webinar-speaker   John E Lincoln

webinar-time   90 Min

Product Id: 706971

Cybersecurity is the art of protecting networks, devices, and data from unauthorized access or criminal use. It is the practice of ensuring confidentiality, integrity, and availability of information, and is a rapidly growing problem for industry. 

Recording Available

* Per Attendee $249

 

Annual Current Good Manufacturing Practices (cGMP) Training

webinar-speaker   Kelly Thomas

webinar-time   60 Min

Product Id: 705422

This webinar provides a basic understanding and fundamental principles of Current Good Manufacturing Practices and will fulfill the requirement of personnel involved in cGMP must have documented training of current Good Manufacturing Practices. This session will focus on the FDC Act and 21 CFR federal regulations as applied to cGMP.

Recording Available

* Per Attendee $249

 

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