Certification in Industrial Pharmaceutical Best Practice

The International Academy of Pharmaceutical Practice will provide Continued Professional Development/ Continuing education courses enabling Practicing Pharmacist to apply World Health Organisation Best Pharmaceutical Practice standards to ensure that safe, effective, and quality medicines are provided to patients worldwide.

These courses will outline the increasing importance of Biopharmaceutical Products which lists the changes required to be made in Product development and Manufacture to ensure that Patients receive Medication that meets the required standards of Quality, Safety and Efficacy. We shall highlight the essential practices requirements for Product Development, Manufacture, Quality Management  of Medicines to assure that All Patients worldwide have access to medicines that meet international standards that will prove affordable medication that will provide effective treatment .

All eLearning courses aim to contribute to the World Health Organization (WHO) objectives of improving Patient Safety by.

• Developing effective medicines which can offer effective Patient treatment .
• Provide effective and affordable medicines in a timely manner. The development /manufacture of covid -19 vaccine is  described in detail as an example of required future practice standards.
• Provide assistance in ensuring good distribution of effective and affordable medicines to ALL Global market.

1. New Developments in The Practice of Pharmacy CPD / CE

   

   This e-lecture identifies the principal drivers for change in the Practice of Pharmacy and proposes ways in which the Pharmacy workforce may adapt to changes in the practice standards to ensure that all Patients receive “Medication Without Harm” in line with the WHO directive 2020. This course identifies the additional skills required by the Pharmacy workforce for working in each of the sectors of pharmacy, and specifies the additional learning as part of the Continued Professional Development.

   Credits: 3 CPD / CME

   No. of Hours: 3 hrs

   Learning Objectives: 

   This training course introduces the skills required to be able to take advantage of the “New Developments in Pharmacy Practice" and to introduce the Four Principal changes required to be made to the Practice of Pharmacy in order to assure greater care and safety of Patients.
   The four Principal changes required in the Practice of Pharmacy are as follows.

   • Support the technology which has lead Development of Biopharmaceutical products that has led to development of the Covid-19 vaccine and Personalised medicine such as treatment for cystic fibrosis.  
   • Adopt the use of Artificial Intelligence, and Manufacturing Intelligence to provide information to allow for improved diagnosis and treatment.
   • To improve Quality and Safety of medicines in the Global supply chain by excluding adulterated and counterfeit medicines and providing traceability of the origin of medicines to identify the sources of those drugs that provide unexpected adverse events 
   • Improve the Affordability of essential drugs by rationalizing the manufacture and distribution of medicines and eliminating all non-value adding activity ensuring that lifesaving medicines are available to all.

   The IAPPS training program if followed will help to ensure the achievement of the above 4 objectives over the next decade

   Who Should Enroll:

   Registered pharmacist practitioners, pharmaceutical scientists, pharmacy technicians and other pharmacy support workforce cadres, pre-service students/trainees) working in a diversity of settings (e.g. community, hospital, research and development, industry, military, regulatory, academia and other sectors) with a diversity of scope of practice 

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2. Current Issues with the Medicine Supply Chain CPD / CE

   

   This course will review the potential treats to the Global Medicines Supply Chain and identify the measures necessary to exclude Counterfeit and adulterated medicines and improve delivery performance bay using Block chain technology and Vendor qualification to verify quality  and Enterprise Resource Planning to improve delivery performance of medicines and a clear understanding of the principals of supply chain management.

   Credits: 6 CPD / CME

   No. of Hours: 6 hrs

   Learning Objectives: 

   On completion of this course the delegate will have an understanding of

   • Stock shortages and the measures necessary to avoid
   • Measures necessary to exclude of counterfeit and adulterated medicines
   • The application of Block Technology and Track and trace to verify the origin of stock
   • The application of ERP software to carry out the processes of; Product requestioning Planning process - Procurement and Purchasing -Vendor qualification & Quality Management and controlled distribution to wholesalers.
   • The application of LIMS (Logistics Information Management Software) to manage stock in Hospital and Community Pharmacies

   Who Should Enroll:

   ALL Persons involved in the Practice of Pharmacy which should include – Pharmaceutical Production, Distribution, Wholesale, Hospital and Community Pharmacies who are Dispensing medicines to the patient

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3. Introduction to Drug Safety- Pharmacovigilance CPD / CE

   

   This training course is designed to give all Health care workers involved in the supply of medicines an introduction to the fundamentals of product safety and regulatory compliance. The interactive eLearning course on Drug safety will comprise of ;

   • Brief History of PharmacoVigilance and drug safety.
   • Differences between adverse event reporting in the clinical vs. post-marketing settings
   • How adverse events are assessed and reported
   • Relationship testing (causality)
   • Adverse event reporting formats
   • Periodic reporting

   and will include case studies of adverse events to illustrate the decision-making process and reasoning needed behind when and how to properly report incidents to regulatory authorities.

   Credits: 6 CPD / CME

   No. of Hours: 6 hrs

   Learning Objectives: 

   By the end of the course you should have an understanding of regulatory requirements for drug safety, and knowledge of how to collect, assess, report and analyze adverse events.

   Who Should Enroll:

   Almost everyone involved in drug development and marketing needs to know the basics of FDA’s regulations regarding drug safety.  Staff who will benefit include:

   • Drug safety and pharmacovigilance
   • Regulatory affairs
   • Clinical development
   • Executives (including C-Level) with any legal responsibility for drug safety

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4. The Convergence of Digital Technologies and Pharmaceutical Practice CPD / CE

   

   This eLearning training course will address the benefits of applying Digital technology to the electronically recorded health care records to improve diagnosis and treatment ,ensuring the effectiveness of medicinal treatment that is made available to all Patients who may require.

   Credits: 4 CPD / CME

   No. of Hours: 4 hrs

   Learning Objectives: 

   On completion of this course the delegate will have an understanding of how the application of  Artificial Intelligence- Machine Learning and Deep Learning to the Electronic health records ,that will provide Digital Healthcare solutions to enable the development of Personalized medicine, secure quality of medicines in the supply chain and facilitate the safe and effective treatment of patients.

   Who Should Enroll:

   ALL Persons involved in the Practice of Pharmacy which should include – Pharmaceutical Production, Distribution, Wholesale, Hospital and Community Pharmacies who are Dispensing medicines to the patient

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5. What you need to know about Pharmaceutical Quality Management Systems CPD / CE

   This course will provide the Essential Practice standards to ensure that medicines have been produced in accordance with the international Quality Management Standards to ensure patient safety.

   Significant increases of adulterated and counterfeit Drugs entering the medicines supply chain due mainly to a failure in the Quality management stem, which requires to be corrected by all persons responsible for the distribution of medicines.

   A Quality Management System (QMS) is a collection of processes focused on consistently achieving the quality objectives and are expressed as the organizational structure, policies, procedures, processes and resources needed to provide patients with a Quality Service.

   This course combines the technical requirements of Good Pharmaceutical Practice as stated in ICH Q10 with the business needs of ISO 9001 and applies them to the management of pharmaceutical products supplied to patients

   Credits: 4 CPD / CME

   No. of Hours: 4 hrs

   Learning Objectives: 

   This course has been prepared in accord with the latest WHO Good Pharmaceutical Practice standards for ensuring that all dispensed Medicines meet the required standards of Quality, Safety and Efficacy as defined by the WHO Annex 1 Quality Management covering a number of factors, which ensures the quality of medicines and Patient safety.

   Who Should Enroll:

   ALL Persons involved in the Practice of Pharmacy which should include – Product Development, Clinical assessment, Manufacturing, Distribution, Hospital and Dispensing medicines to the patient

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6. Principals and Techniques of the Quality Risk Management CPD / CE

   

   Principals and Techniques of the Quality Risk Management are required to determine if a Product or Process deviation presents a potential risk to the Patient and if so, how it  can be mitigated to ensure the  patients safety.

   This eLearning course provides the principles and tools which can be used to Manage the Risk to Quality of Medicines which can be applied to different aspects of pharmaceutical quality.

   This includes all aspects involved in the Development , manufacture and supply of drug substances to assure the Quality Safety and Efficacy of medicines for Patients

   Credits: 4 CPD / CME

   No. of Hours: 4 hrs

   Learning Objectives: 

   This course will provide an introduction to the skills and competencies required, to Assess and control out of specification and Product/Process deviation by Quality Risk Management. The candidate will learn how to asses and mitigate risk by using techniques such as Risk cause analysis and failure mode Effect analysis to identify and mitigate the potential risk.

   Who Should Enroll:

   Persons  involved in Pharmaceutical Processes – Product Development, Clinical assessment, Manufacturing , Distribution, Pharmacovigilance, and Dispensing medicines to the patient

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7. The Principals of Quality by Design CPD / CE

   

   The application of the Principals of Quality by Design will built QUALITY into a product from an understanding of the product and process and knowledge of the Critical to Quality attributes and Critical Process parameters involved in manufacturing the product to achieve the optimum Quality Target Product Profile.

   The lecture will review the systemic, knowledge and risk-based quality methodology used to ensure the consistency of product, and will provide a case study in which to demonstrate the application of the Quality By design principals, and will provide an assessors view of the measures proposed in the lecture “Regulatory Assessment requirements of Quality by Design data”.

   Credits: 3 CPD / CME

   No. of Hours: 3 hrs

   Learning Objectives: 

    This course will provide the key steps used in Quality by Design , and which will include the development of the API manufacturing process, Formulation of the Drug product and standards for batch release, the essential part of the process is to assure the control of quality by qualifying the following controlling factors for the product;

   • Quality Target Product Profile (QTPP)
   • Critical Quality Attributes (CQA)
   • Critical Process Parameters (CPP)
   • Design Space (DS)
   • Control Strategy
   • Process Analytical Technology (PAT)

   Who Should Enroll:

   All Staff involved in Pharmaceutical, Product Development, Clinical assessment, Manufacturing, Distribution, and Registration.

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8. Manufacturing Practice Update for producing Biopharmaceutical Products CPD / CE

   This course will detail the latest developments and techniques of Biotech production and provide an overview of current activities in genomics, in their translation into new drug that can deliver effective treatment.

   The recent demand on Pharma Companies to urgently produce an effective Covid-19 vaccine has required they apply the latest digital technology to current knowledge of the genomic structure of the virus , to ensure that the newly developed vaccine is produced in accordance with the appropriate Manufacturing Practice standards to ensure that the finished vaccine is compliant with the required  specification to ensure the efficacy of the new vaccine. 

   This course will detail the latest developments the techniques of Biotech production and provide an overview of current activities in genomics, in their translation into new drug discovery and the delivery of personalized medicine.

   Credits: 4 CPD / CME

   No. of Hours: 4 hrs

   Learning Objectives: 

   This eLearning Course will provide an overview of the following.

   • The Manufacturing Practice standards required to produce the new generation of Covid vaccine Biopharmaceuticals.
   • Use of Deep Learning in assessing the Pharmacogenomics when developing modern Biopharmaceutical Medicines.
   • Properties of Biopharmaceuticals .
   • The Biotechnology Manufacturing Process
   • Development of the Covid-19 vaccine
   • The facts about Bioequivalence of Biosimilar products

   Who Should Enroll:

   Pharmacists and Pharmaceutical Scientists needing to know about the development in Pharmaceutical Standards for the manufacture of Biopharmaceuticals

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