9 Exclusive Webinars on Pharmaceutical Organizations Standards and Requirements

This package training program helps the participants to learn about QMS that are common to the pharma and medical devices and how to implement QMS in one umbrella, learn about the proposed changes to USP 797 and 795 rules for compounding for individual patients as well as 'for office use' compounding, and more. How to master a standardized approach to technology transfer projects. Join this training to learn the best practices for effective pharma technology transfer. Learn to review new materials in the GS1 US guideline and help you prepare to comply with the 2023 requirements, learn more about AE, SAE, AR and SUSAR, reporting timelines, sources of information, preclinical, clinical and post marketing, and more, learn the regulations pertaining to objectionable microorganisms and the methods to control and reduce the amount of objectionable microorganisms. Attend this trending webinar to learn about principles of Total Organic Carbon Analysis, analytical approaches in different instruments, setting limits based on TOC and get trained on importance of quality in Compressed Air, Pharmaceutical Compressed Air System Design, Contamination Prevention, GMP Testing Standards and more.
Instructor: Meena Chettiar, Dr Sue Hudson Duran, Igor Gorsky, Gregory Martin, Robert Celeste, Sue Fitzpatrick, Carl Patterson, Joy McElroy, Roger cowan,
Product ID: PACK70063

CD/Recorded-How It Works:

  • Webinar CD/Recorded will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations
  • Webinar Recording Link or CDs are licensed to be used multiple times at any location with multiple attendants
  • Get unlimited access for Recorded links
  • Free shipment of CDs within 72 hours from the date of purchase
  • Reference materials for Webinar Recording Link/CDs will be mailed to your registered e-mail id

Webinar Topics:

Who will benefit?

  • Quality Managers/ Directors
  • QA/QC and Regulatory Professionals in pharmaceutical and medical device industries
  • Quality Engineers and Quality Auditors
  • Supply Chain Managers/Auditors
  • Management professionals in FDA Regulated industries
  • R&D and design engineers
  • Global professionals looking for employment in medical device and pharmaceutical industries
  • Sterile products pharmacists
  • Compounding pharmacists
  • Veterinary compounding pharmacists
  • Pharmacists in charge
  • Chief operating officers
  • Chief compliance officers
  • Facilities managers and building engineers
  • CNOs
  • Quality and infection control managers
  • Project management
  • Product/process and formulation development
  • EH&S
  • Analytical development
  • Microbiology
  • Technical services
  • Operations
  • Manufacturing
  • Packaging Engineering
  • Serialization
  • Chemists
  • Laboratory Managers
  • Quality Assurance personnel responsible for generating GMP or GLP data or assuring readiness for a regulatory inspection
  • IT/IS
  • Documentation
  • Regulatory
  • VP or Director of I.T.
  • Persons responsible for licensing/registration
  • Manufacturing and distribution/supply chain
  • Anyone new to the GS1 System of Standards
  • Professionals in Production and Supply Chain
  • Outsourcing Managers
  • Procurement, R&D Managers
  • Clinical Research Professionals
  • Compliance Departments
  • Regulatory Departments
  • Drug Safety Professionals
  • Pharmacovigilance Professionals
  • Research and Development
  • CROs
  • AROs
  • Quality compliance
  • Any personnel that may be involved in safety reporting when conducting clinical trials or following the marketing authorization of a product
  • Anyone who would like to enhance their knowledge and understanding of drug safety
  • Production
  • Logistics
  • Manufacturing
  • Quality system auditors
  • QA directors and managers
  • Microbiology analysts and technicians
  • Consultants
  • Regulatory and Compliance Management
  • QC Analysis Technicians
  • Disinfectant validation managers
  • Operations managers
  • Manufacturing operators
  • Clean room managers
  • Clean room operators
  • Personnel and contractors that clean and disinfect clean rooms
  • Regulatory compliance managers and environmental monitoring managers
  • EH&S managers
  • Validation Engineers and Specialist
  • Maintenance

Webinars included in the Package:

The Blue Print for Implementing Pharmaceutical and Medical Device Quality Management System under one Umbrella (Duration: 75 Minutes)

Professionals are often thrown into the challenge of adapting and expanding their quality system requirements in order to accommodate their expanding business and customer needs. This webinar will help you overcome the challenge by educating you on the QMS needs that are common and those that are unique to Pharma and Medical device world so you can focus on areas that need to be nurtured as you make this important transition from 21 CFR 210/211 to 21 CFR 820 and vice versa to fulfill FDA regulatory needs for your effective quality system that will be housed under one umbrella.

Objectives of the Presentation:

  • What are the features of QMS that are common to the pharma and medical device QMS?
  • Which features are unique to the world of medical devices for globally marketed products?
  • Which features are unique to the pharmaceutical/drug world?
  • What is required to fulfill the cGMP needs of the fast growing Combination products?
  • How should the gap analysis be performed for a seamless transition?
  • Planning and implementation of your QMS under one umbrella to successfully withstand scrutiny by worldwide regulatory bodies and for your overall business risk management

Instructor Profile:

Meena Chettiar has a very strong background in Quality in the FDA regulated industries. Meena is currently working as a Senior Associate at NAMSA and is the Founder and Principle Consultant of MNQ Consulting Services LLC. Meena has also worked for Agriculture and Health Canada in several technical capacities for about 10 years. Meena has performed mock QSIT Audits and has responded to several FDA 483s. She is ASQ certified CQA (Certified Quality Auditor), CBA (Certified Biomedical Auditor), CQIA (Certified Quality Improvement Associate), and CMQ/OE (Certified Manager of Quality/Organizational Excellence).

USP 797/USP 795: Reviewing the Proposed Changes & How to Create and Manage a State of Control in Pharmacies (Duration: 60 Minutes)

In this webinar, our speaker Sue Hudson Duran will cover the USP 797 and 795 rules for compounding for individual patients as well as for 'office use' compounding. The speaker will also discuss how changes to USP 800 for Hazardous drugs relate to USP 797 and USP 795. This webinar will cover information for both human and veterinary medicine, for pharmacists, veterinarians, pharmacy technicians, veterinary technicians and anyone ordering 'for office use' compounded drugs.

Objectives of the Presentation:

  • To discuss the different regulations for states as to 'for office use' compounding
  • Importance of pyrogen- free water; avoiding water as a source of contamination
  • Emphasis on particulate count and the role it plays in cleaning sterile products rooms
  • Safety associated with sterile compounding and closed syringe systems
  • How USP 800 Hazardous Drug Handling coordinates with USP 795 and 797 compounding
  • Review of FDA violations in compounding pharmacies and pitfalls to avoid

Instructor Profile:

"Dr Sue Hudson Duran is a professor at Auburn University College of Veterinary Medicine and Adjunct Clinical Professor, Harrison School of Pharmacy, Auburn, Alabama. She has experience as a GMP pharmacist in pharmaceuticals, biologicals, nutraceuticals and food. She is an active member of the Auburn Food Systems Institute. She has been the safety officer at the College of Veterinary Medicine since 2000, serving to educate medical professionals in safe handling of drugs.

Best Practices for Effective Pharma Technology Transfer: From R&D to Clinical to Commercial (Duration: 90 Minutes)

This webinar discusses effective Pharmaceutical Technology Transfer procedures as they are currently practices by successful pharmaceutical and biopharmaceutical firms. It introduces compliant modular approach to technology transfer projects that covers multiple disciplines including Project Management, Analytical and Microbial Quality Control, Operations, Quality Assurance Safety, Engineering, Regulatory Affairs and other relevant areas. It provides guidance for creation of a powerful, effective and efficient governance team. In addition we will outline step-by-step joint quality review stage-gate approach that will help dissecting complex technology transfer exercises into manageable and compliant phases taking into consideration regulatory filing recommendations. We will also include discussion on Risk and Knowledge Management tools as they apply to Technology Transfer projects.

Objectives of the Presentation:

  • Effective project management of technology transfers
  • Appropriate governance of technology transfer projects
  • Modular approach introduction
  • Using risk management and knowledge management
  • Understanding of Joint Development and Technology Transfer Reviews
  • Regulatory filing and Pre-approval inspection preparedness

Instructor Profile:

Igor Gorsky has been a pharmaceutical industry professional for over 30 years. He held multiple positions with increasing responsibility at Alpharma, Wyeth and Shire. His over the years accomplishments include validation of all of the aspects of pharmaceutical and biotechnology production and quality management, technical support of multi-billion dollar drug product lines and introduction of new products onto the market. He had published articles and white papers in pharmaceutical professional magazines and textbooks. In addition he had been a presenter at Interphex.

Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory (Duration: 90 Minutes)

This 90 Min laboratory inspection webinar will discuss strategies to implement before your laboratory is about to undergo a pre-approval inspection or a general GMP inspection. It will help you gain an understanding of the key areas that are likely to be the subject of a laboratory inspection.

Objectives of the Presentation:

This laboratory inspection course is designed to provide participants with an understanding of the areas which are likely to be the subject of a laboratory inspection, whether it is a Pre-Approval Inspection or a general GMP inspection. By understanding the expectations, the participants will be able to develop a strategy to minimize issues should their laboratory be inspected.
  • Upon completion of this course the participant should:
  • Be familiar with the areas in which regulatory inspectors are likely to probe
  • Be aware of the general expectations for each of these areas
  • Develop an overall strategy to minimize the likelihood of issues arising during an inspection
Due to the diverse interests of the participants, questions will be actively solicited and addressed by the end of the webinar.

Instructor Profile:

Greg Martin is the President of Complectors Consulting, which provides consulting and training in the area of Pharmaceutical Analytical Chemistry. Mr. Martin has over 25 years experience in the pharmaceutical industry and was the Director of Pharmaceutical Analytical Chemistry (R&D) for a major PhRMA company for a number of years. Mr. Martin is the author of several papers in the areas of dissolution and analytical method validation, and was the past chair of the AAPS In Vitro Release and Dissolution Testing Focus Group.

New GS1 US Guideline - Pharmaceutical Industry Prepares for DSCSA Item-Level Traceability Requirements (Duration: 90 Minutes)

Members of the US Pharmaceutical Supply chain will begin to use the GS1 EPCIS suite of standards to comply with provisions of the DSCSA law due to be in effect on November 27, 2023. This training will review what is required, timelines for implementation and how to use the GS1 US Guideline to comply and prepare to share serialized data with your trading partners.

Objectives of the Presentation:

  • Learn why current solutions may not work moving forward
  • Be able to describe what your company needs to do to meet the next set of requirements
  • Understand the suite of standards the industry is using to comply with DSCSA
  • Understand key business processes and how to account for them using the guideline
  • Prepare to be able to respond to trading partner requirements if errors occur
  • Be able to create a RFP for enhancements to your current solution

Instructor Profile:

Robert Celeste has over 30 years of experience in the chemical, financial, pharmaceutical, medical device and retail industries with a focus on business process re-engineering, information management, standards development and usage. For the past 13 years, Bob was Senior Director, Healthcare with GS1, EPCglobal and GS1 US where he worked with the healthcare industry and regulators on the proper use of Traceability and Master Data Management standards and procedures.

Drug Safety and Pharmacovigilance: Effective Drug Safety Reporting and Surveillance (Duration: 90 Minutes)

This course provides a background to safety reporting. There is a refresher on the definitions and reporting requirements of AE, SAE, AR and SUSARs, within a clinical trial. We look at the sources of safety information and discuss the evidence that points to the causality of an event. The change in the regulatory environment is reviewed and the role of conditional approval and PASS and PAES studies is also discussed. The requirement of a DSUR (development safety update report) and PSUR (periodic safety update report) is covered.

Objectives of the Presentation:

  • Meet regulatory requirements for product safety
  • Signal detection algorithms and methods used
  • Hazard modeling
  • Collect, assess and report adverse events
  • DSURs and PSUR requirements
  • Identify differences between U.S. and European regulatory requirements

Instructor Profile:

Sue Fitzpatrick has more than 30 years' Pharmaceutical Industry experience. She has been responsible for the management and audit of CRAs, CROs and clinical trials in a wide range of therapeutic areas. As former Director and Head of Education and Training at the Institute of Clinical Research she was responsible for the provision of training courses for the industry and for postgraduate courses in collaboration with several UK Universities. Sue is an accredited teacher with Cranfield University and continues her collaborations but as a consultant trainer.

Risk of Presence of Objectionable Microorganisms in Biopharmaceutical Production (Duration: 60 Minutes)

Objectionable microorganisms are considered, if discovered, harmful to the patients. By identifying and controlling these microorganisms, and putting the appropriate controls in place early in the pharmaceutical manufacturing or medical device manufacturing processes, problems in the patients can be prevented. This webinar will review the regulations pertaining to objectionable microorganisms, agency expectations, methods to identify objectionable microorganisms, interpreting results, and controls to put into place. By knowing, where, when, why and how objectionable microorganisms exist, harmful consequences to the patients can be prevented.

Objectives of the Presentation:

  • Regulations pertaining to objectionable microorganisms
  • Knowing what microorganisms are considered objectionable
  • The importance of knowing what microorganism are there in your product
  • Identifying objectionable microorganisms
  • Sources of microorganisms in pharmaceutical manufacturing facility
  • How to determine if you have an objectionable microorganism
  • Tests to determine objectionable microorganisms
  • Methods to control and reduce the amount of objectionable microorganisms

Instructor Profile:

Carl Patterson, M.S. has completed twelve plus years in the biotechnology, pharmaceutical manufacturing and quality fields. He completed his Bachelor's of Science in Microbiology from the University of Texas. Also, has completed specialized certificates in biotechnology manufacturing, quality control, and quality assurance from UCSD, and has completed his Master's of Science in Biomedical Quality Systems from SDSU.

Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing (Duration: 60 Minutes)

This webinar will demonstrate Total Organic Carbon (TOC) feasibility, method validation and transfer from the laboratory to the manufacturing floor, as well as reviewing a feasibility study of multiple, difficult to oxidise or low solubility organic compounds.

Objectives of the Presentation:

  • Understand the Chemical Basis of TOC Analysis
  • Learn how to set limits based on TOC
  • Learn how to validate TOC as an analytical method for cleaning validation purposes
  • Understand possible interferences from sampling and analysis
  • Optimization of TOC recovery for difficult to oxidize or solubilise compounds
  • Learn appropriate uses of TOC throughout the validation life cycle
  • Benefits of at-line and on-line sampling

Instructor Profile:

Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing environmental monitoring and sterility testing. Her hard work allowed her to move into a supervisory role at Abbott Laboratories where she oversaw their quality control lab. In 1998, Ms. With over 20 years of total experience in the pharmaceutical and biotech industries, Ms. McElroy has gained extensive knowledge of quality assurance, process and cleaning validation, equipment qualification, sterilization, and GMP compliance auditing. Her knowledge, experience, and strong work ethic have made her a highly sought-after engineer in both the pharmaceutical and biotech industries.

Pharmaceutical Compressed Air - Quality GMP Standards and Requirements (Duration: 60 Minutes)

Compressed air is often overlooked as a potential source of clean room and product contamination. This webinar will give you an understanding of the different types of contamination inherent in compressed air and how to prevent each from affecting your particular system. A detailed description of a typical pharmaceutical compressed air system with its individual components is provided. Engineering schematics are included. All component functions are detailed with recommendations as to which component type is considered optimal.

Objectives of the Presentation:

  • Compressed Air - Importance of Quality
  • Pharmaceutical Compressed Air System Design
  • Contamination Types and Sources
  • Contamination Prevention
  • International GMP Testing Standards
  • Testing Methods and Specifications

Instructor Profile:

Roger cowan has 32 years of experience in pharmaceutical R&D, manufacturing and QA management. He has established his own Consulting Services LLC, (http://www.pharmaconsultation.com/), Presently he is a Independent consulting to the pharmaceutical industry primarily in the area of pharmaceutical. His specialties include: aseptic pharmaceutical manufacture, GMP facility audits, technical transfer, microbiology, environmental monitoring/contamination control, product sterilization, process development, process validation, clinical supply manufacturing, labeling and distribution, US /international regulatory requirements, regulatory submissions, and quality assurance/control.

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