19 Training Courses to Get to Know the Best Practices in Pharmaceutical Industry

Product ID: PACK70066

Instructor:  Meena Chettiar, Dr. Sue Hudson Duran, Igor Gorsky, Gregory Martin, Robert Celeste, Sue Fitzpatrick, Carl Patterson, Joy McElroy, Roger Cowan, Michael Esposito, Tim Sandle, Sara Zborovski, Gary Koesten, Angela K. Dunston, Kenneth Christie, Howard T C

This set of course is designed to provide you with an understanding of the multiple areas within the Pharmaceutical industry. You will get information about the requirements and best practices for the Pharma Industry which will include Effective Pharma Technology Transfer, Implementation of Pharma management system, manufacturing, Advertising and marketing of products, Inspection and safety guideline and so on.

Webinar Topics Included:

1. The Blue Print for Implementing Pharmaceutical and Medical Device Quality Management System under one Umbrella

In this webinar, the presenter with 1st hand proficiency in setting up and speaking the quality language of medical device and the Pharma world will provide unique tips for those companies that are making the transition from medical device to pharmaceuticals and vice versa or in to the fast growing world of drug coated medical devices also known as Combination Products.

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:
Ms. Chettiar has a very strong background in Quality in the FDA regulated industries. Ms. Chettiar received her M.S. in Regulatory Affairs for Medical Devices in Minnesota, USA, and M.A. SC in Chemical engineering from University of British Columbia in Canada and her B.S. and M.S in Applied Chemistry from the University of Madras, India.

2. USP 797/USP 795: Reviewing the Proposed Changes & How to Create and Manage a State of Control in Pharmacies

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, nutraceutical and food.

3. Best Practices for Effective Pharma Technology Transfer: From R&D to Clinical to Commercial

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

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. He worked in Production, Quality Assurance, Technical Services and Validation including an Associate Director of Global Pharmaceutical Technology at Shire Pharmaceuticals

4. Laboratory Inspection Readiness - Implementing GMPs for the Pharmaceutical Laboratory

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:
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

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 Pharma company for a number of years.

5. New GS1 US Guideline - Pharmaceutical Industry Prepares for DSCSA Item-Level Traceability Requirements

This webinar will review new materials in the guideline and help you prepare to comply with the 2023 requirements. There are additional requirements that have yet to be decided within the industry that you need to be aware of and follow as they are resolved by industry and the FDA.

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:
Bob 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.

6. Drug Safety and Pharmacovigilance: Effective Drug Safety Reporting and Surveillance

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.

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.

7. Total Organic Carbon Analysis for Cleaning Validation in Pharmaceutical Manufacturing

Total Organic Carbon (TOC) is a useful analytical method for cleaning validation studies, including design, qualification and routine monitoring. While there may be some confusion with the industry and regulatory bodies about the use of this analytical technique, it is widely used because of certain benefits. The basis of TOC as an analytical technique will be covered, involving the various technologies currently utilized. Cautions in sampling and analyses will be discussed, including the appropriate use of blank and controls.

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 Upon earning a degree in Zoology from North Carolina State University, Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing environmental monitoring and sterility testing.

8. Pharmaceutical Compressed Air - Quality GMP Standards and Requirements

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. Finally, a compilation of all FDA/EU GMP Guidance, USP/EP and ISO air standards are presented. Sampling and testing methodology for each of these specifications is discussed.

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.

9. Objectionable Microorganisms - Knowing What and Where You Can Find Them in Biopharmaceutical Manufacturing

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 patient can be prevented.

Objectives of the Presentation:

  • Regulations pertaining to objectionable microorganisms
  • Knowing what microorganisms are considered objectionable
  • The importance of knowing what microorganisms are 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.

10. Using a Learning Management System (LMS) to Develop Pharma Training Curricula

This course will describe the development of job position curricula in the Pharmaceutical industry using a Learning Management System (LMS) and provide you with the tools needed to create effective curricula.

Objectives of the Presentation:

  • Articulate what constitutes a Pharma curriculum
  • Distinguish a true Pharma curriculum from common misconceptions regarding Pharma curricula
  • Work effectively with peers and management to set up curricula for their organizations
  • Obtain details of employees’ job functions that are necessary for setting up curricula
  • Create curricula that are intuitive for employees
  • Demonstrate training compliance to auditors through the effective use of curricula

Instructor Profile:
Michael Esposito has over 30 years experience in the pharmaceutical industry and 17 years experience in GMP training and document management.

11. Problem Solving - Root Cause Analysis in Pharma Manufacturing

This topic will touch on investigations whether they are post-Audit, Deviation related, Complaints, etc. It will transition into determination of RCA, the many tools used during RCA & what they really are and how to use them to greater effect.

Objectives of the Presentation:

  • Relevant inspection steps in relation to Root Cause
  • How to use RCA to better effect
  • What RCA tools really are and their place in RCA
  • Why Human Error doesn’t exist
  • How to use your RCA to formulate better CAPAs

Instructor Profile:
Joy McElroy Upon earning a degree in Zoology from North Carolina State University, Joy McElroy made her debut in the pharmaceutical industry in 1992 at Pharmacia & UpJohn performing environmental monitoring and sterility testing

12. Effective Pharmaceutical GMP Audits and Self-Inspections

Regulators expect audits and self-inspections of the manufacturer to assure the quality of its own operations and those of its suppliers and contractors via repeated audits. Because of the extreme criticality of GMP audits and the potential consequences, many pharmaceutical manufacturers have adopted a program of internal GMP audits in order to find and correct areas where the firm is not in full compliance with the GMP regulations before an FDA audit occurs. This webinar will provide you with the knowledge, understanding, skills and confidence to audit all aspects of pharmaceutical manufacture and control, whilst retaining the cooperation and respect of the other auditors.

Objectives of the Presentation:

  • Understand the GMP context for pharmaceutical quality system lead auditors
  • Plan, conduct, report and follow-up an audit of a GMP PQS
  • Provide guidance for auditors of suppliers, contractors, CMO service providers, outsourced activities and self-inspectors
  • Drive continuous improvement of systems and processes
  • Drive continuous improvement of auditors and audit systems

Instructor Profile:
Carl Patterson, M.S. has completed twelve plus years in the biotechnology, pharmaceutical manufacturing and quality fields.

13. Fungal Contamination and Pharmaceutical Products Recall

Over the past decade, the number of pharmaceutical product recalls due to fungi has increased significantly, with many different product groups affected. Data suggests a link between product contamination and the process environment. A key concern is a lack of knowledge, even among microbiologists, about identifying fungi and understanding their origins. This webinar will explain different types of fungi, risks to products, guidance on identification, and a focus on remediation measures to remove, eliminate and to prevent fungi.

Objectives of the Presentation:

  • To learn about fugal risks
  • To appreciate the extent of pharmaceutical product recalls relating to fungi
  • To understand which types of medicinal products are most at risk
  • To learn about the common types of fungi associated with clean rooms
  • To understand the main points of contamination
  • To learn about monitoring techniques
  • To learn about good disinfection practices
  • To understand other remediation activities

Instructor Profile:
Dr. Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing.

14. Canadian Advertising and Marketing of Pharmaceuticals, Medical Devices and Natural Health Products

This webinar will provide attendees an overview of the relevant statutes, including the Competition Act, Food and Drugs Act and relevant regulations and information about the existence and operation of Canadian advertising pre-clearance agencies. The rules around advertising and marketing health products will be explained using examples, and hot topics in advertising and marketing will be covered, including the use of social media, testimonials and endorsements.

Objectives of the Presentation:

  • Introducing the general principles of advertising and marketing law in Canada such as the Competition Act , the Food and Drugs Act and Canadian Codes of Advertising Standards.
  • The prohibition on false and misleading advertising
  • The importance of product classification and the general rules around advertising and marketing drugs, natural health products and medical devices
  • Canada-specific considerations like advertising Pre-Clearance Agencies, Provincial legislation and oversight and Privacy legislation
  • The use of social media, Testimonials and Endorsements

Instructor Profile:
Sara Zborovski is a partner at the law firm of Davis LLP in Toronto. She assists companies regulated by Health Canada and the FDA obtain market access and in all areas of compliance.

15. Sterile Filtration of Pharmaceutical Products - Validation and Regulatory Requirements

It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs to differ based on the filtration requirement. This webinar will give you a comprehensive understanding of this important subject with an emphasis on the different types of sterilizing filtration available and their application to your particular system. For example, the application of sterile filtration to use-point compressed air is discussed in detail.

Objectives of the Presentation:

  • Sterile filtration – Importance of Quality
  • Sterility Assurance of Sterile Filtration
  • Sterile Filtration System Design
  • Discussion of Different Filtration Media Properties and Retention Mechanisms
  • Methods for Sterilization of Filters
  • Validation of Sterile Filter Systems
  • Microbial Retention Challenge Testing
  • Integrity Testing
  • Product Compatibility Testing
  • Extractable/Leachable Testing
  • Regulatory Requirements

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.

16. Licensing and Regulatory Compliance in Mail Order Pharmacy

This program discusses the advantages and pitfalls for pharmacy and pharmacist licensure in other states. Being licensed in multiple states potentially create issues of compliance especially when there is a conflict of law between the state where the pharmacy is located and the state the prescription medication is being delivered to.

Objectives of the Presentation:
The objectives of the Presentation are to give the participants a fair idea on:

  • Which states require non-resident licenses
  • Which states require a pharmacist to also be licensed in that state
  • The process for pharmacy licensure
  • Pharmacist license reciprocity to another state
  • Unique pharmacy laws that could create conflict of law
  • VIPPS and Vet-VIPPS certification
  • Other certification and accreditation bodies

Instructor Profile:
Gary is licensed as a pharmacist in FL, NY, TN, AL, AR, AZ, NE, MD, MS, LA, KY, OR, WV, and VA. Gary is also licensed as a Consultant Pharmacist in FL. He is a member of the American Society for Pharmacy Law.

17. GMP Data Integrity Best Practices and Regulatory Expectations for the Pharmaceutical Industry - A Review of the New MHRA GMP Data Integrity Definitions and Guidance Release in January 2015 & What to Expect from the FDA in the Future

In this webinar we will examine the issues surrounding data integrity lapses. We will examine the types, how to detect them, how to determine the root causes for these failures. We will examine how the Europeans have taken the issue seriously and are meeting the challenge face on by reviewing the new MHRA GMP Data Integrity Definitions and Guidance released in January 2015. The FDA approach has been less direct but still forceful. We will predict how they are going to tackle this issue in the future. The tools described will aid you in detecting, measuring, investigating and remedying the failures leading you to regaining the trust of your customers.

Objectives of the Presentation:

  • MHRA GMP data integrity definitions and guidance
  • How to examine your supply chain and development programs with the use of Quality Risk Management to identify the risk of data integrity lapses
  • The tell-tale signs that you have data integrity problems
  • To tell the difference between intentional and unintentional failures of data integrity
  • How to develop a remediation plan to decrease risk to an acceptable level in your operations
  • How to be proactive in areas the FDA is silent by learning from the Europeans and being ahead of the game
  • How regulatory agencies detect data integrity problems

Instructor Profile:
Angela K. Dunston has over 20 years of experience in manufacturing and laboratory quality and compliance in the pharmaceutical, biotechnology, and medical device (diagnostics) industries.

18. Best Practices for Effective Environmental Monitoring Program in Bio/Pharmaceutical Production

This course will focus on three major points: The regulatory requirements for environmental monitoring, Main issues with environmental monitoring programs such as monitoring locations and the justifications for them, the types of sampling, and the establishment of operational limits, the handling of excursions and what are some of the common deficiencies cited by regulatory auditors.

Objectives of the Presentation:

  • Review the current regulatory requirements and guidelines (CFR, EU GMPs, ISO, etc.) for environmental monitoring
  • Discuss the issues of sampling methods, selection of sampling sites and the justifications for them
  • Review the issue of contamination control as an important aspect of EM programs
  • Discuss the issue of action and alert limits, trending of data and the handling of excursions to them
  • What are the most common deficiencies cited by regulatory auditors when auditing environmental monitoring programs?

Instructor Profile:
Kenneth Christie has over 30 years of sterile manufacturing and regulatory GMP consulting experience in the areas of Quality Assurance and Validation Management in the pharmaceutical and biotechnology industries.

19. Mapping the ICH Q10 Quality System to ICH Q7A, Active Pharmaceutical Ingredients GMP and Part 210-211, Final Dosage GMP

The ICH Q10 Quality System Model is very general because it represents the consensus of several regulatory bodies. Therefore, each regulatory body regulation impacted by the ICH Q10 must be correlated to ICH Q10 and vice versa. Sometimes there is no direct correlation so what do you do? How about conflicts? Such issues will be discussed for potential solutions.

Objectives of the Presentation:

  • To assist the implementation of ICH Q10 by correlating directly to the primary regulation
  • Provide potential answers to conflicts between the regulation and ICH Q10
  • To analyze the ICH Q10 Quality System Model in order to provide the attendee with information and insight that increases their understanding of the related quality system principles
  • To explain the workings of the Quality System model so that it may be designed and implemented to be in effective

Instructor Profile:
Howard T Cooper has over 40 years’ experience managing, designing, developing, implementing, and mitigating GMP quality systems in the pharmaceutical, medical device, nutraceutical, & food industries.

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  • Recorded sessions will have a series of modules. Our experts have delivered the modules using PowerPoint Presentations
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  • Get unlimited access for Recorded links
  • Reference materials for Webinar Recording will be mailed to your registered e-mail id

Who will benefit?

  • 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
  • Veterinary compounding pharmacists
  • 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
  • Technical services
  • Manufacturing
  • Packaging Engineering
  • Serialization
  • Chemists
  • Laboratory Managers
  • IT/IS
  • Documentation
  • Operations
  • 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
  • Procurement
  • Clinical Research Professionals
  • Drug Safety Professionals
  • Pharmacovigilance Professionals
  • CROs
  • AROs
  • Any personnel that may be involved in safety reporting when conducting clinical trials or following the marketing authorization of a product
  • Disinfectant validation managers
  • Operations managers
  • Clean room managers & operators
  • Validation Engineers and Specialist
  • Quality system auditors
  • Microbiology analysts and technicians
  • LMS administrators
  • Training managers and their supervisors
  • Subject matter experts
  • Process Automation Staff
  • Product Development Analysts
  • New QA personnel involved with auditing for virtual companies
  • Contract manufacturing organizations
  • API suppliers
  • Excipient suppliers
  • Packing component suppliers
  • Service providers
  • Maintenance / engineer staff
  • Medical staff
  • Biotechnology
  • Healthcare
  • Academia
  • In-house legal department
  • Business development within any pharmaceutical, medical device or natural health product (dietary supplement) company which is advertising/marketing product in Canada
  • Those Pharmacy owners looking to expand their business into mail order pharmacy
  • Compliance Auditors and Management
  • Process Development Scientists and Management
  • Supply Chain and Logistics Managers
  • IT Management and Staff working in Regulated Areas
  • Equipment Vendors
  • Contract Research Organizations
  • Manufacturing and Laboratory contractors to the industry

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