The Center for Professional Innovation & Education, Inc.
CfPIE Provides Highly Qualified Instructors: Our expert instructors deliver a unique blend of current industry experience with a deep understanding of adult learning principles.
Convenient Course Formats: You can choose from classroom or on-site training formats that accommodate both personal schedules and organizational concerns.
Industry-Recognized Certification: Our Certification Programs provide knowledge and credibility to individuals and their organizations, and programs can be tailored to specific personal interests and need.
RAPS & PharmaTrain Approved Courses: Attendees to our courses can earn Regulatory Affairs Certification (RAC) credits through the Regulatory Affairs Professionals Society (RAPS). All courses are approved by PharmaTrain.
Periodic Product Quality Reviews or Annual Product Reviews of drug products are required by the U.S., EU and Canada. If used effectively, these reviews can be a powerful Quality Assurance tool. The Product Review Process includes: Process Performance and Product Quality Monitoring, Corrective Action/Preventive Action, Change Management and Management Review which are enablers identified in ICH Q10, The Pharmaceutical Quality System. It also includes the ICH Q10 enablers of Knowledge Management and Quality Risk Management. Contemporary guidance suggesting that the Annual Product Review can support the concept of Continued Process Verification and Quality Metrics.
The purpose of the course is to educate the participant in the regulatory requirements for the Annual Product Review while demonstrating the power of the Periodic or Annual Product Review as a Quality Assurance and Quality Improvement tool.
This course will provide participants with an appreciation of the key quality considerations for EU regulatory dossier submissions for marketing approval, with an emphasis on elements where specific European requirements additional to ICH guidelines must be factored into the Common Technical Document (CTD). EU guidelines impacting drug substance and starting materials, as well as the use of the CEP (Certificate of Suitability) and ASMF (Active Substance Master file) filing routes will be covered, along with quality requirements applicable to specific types of drug product filing.
Challenges presented to the global dossier by key differences between EU and US regional quality/CMC requirements in the CTD, as well as through EU product information and labelling requirements will be analysed in detail. Other specific types of regulatory interactions involving quality submissions (e.g. method of sale ‘switching’, batch specific requests, QP Declarations) will be discussed also.
Upon completion of this course, each participant will have an in-depth overview and understanding of the medical marijuana industry starting with the business concept and ending with product sale. Tools, methods and techniques will be employed throughout the course topics to help ensure the planning and execution process is completed in a timely manner while avoiding the typical pit falls that increase cost and extend schedules. Generally acceptable good manufacturing practices and good engineering practices will be integrated throughout the course to provide a robust and repeatable process for compliance with maximum uptime to enable a return on investment. Employee training, building system commissioning and validation, security, cleaning, sanitization and other Standard Operating Procedures (SOPs) will be introduced.
Ever since major issues with Compound Pharmacy manufacturing came into the spotlight in late 2012, the FDA has been actively working to put regulation in place to prevent such occurrences from happening in the future. While this has been a good change for consumers, many Compound Pharmacies have been struggling to understand these new requirements and apply them to their facilities and processes. It is true that many of the principles and regulations are standard in the “Pharmaceutical Industry”, but Compound Pharmacy facilities do not necessarily fit in that category, and so some of these practices and requirements may not be familiar to them. It may be logical to hire consultants to come in to do the work, but many compound pharmacies do not find this cost effective. In addition, many find that implementation and changes can be easily made in house, once they understand the requirements and their intent.
Participants will learn what the FDA requirements are regarding . . .
This course will provide participants with an understanding of drug safety at the investigational stage and during the marketing phase. Adverse event identification and reporting requirements will be addressed, as well as FDA, EMA, Health Canada and ICH roles in the drug safety process. The course will also discuss international law/regulations, ICH guidelines, Pharmacovigilance, definitions and current regulatory issues.
Adverse Event reporting requirements specific to the US, Canada, Japan, and Europe will be discussed and compared in detail. Participants will be provided with templates for reporting requirements in each region covered.
Multiple exercises are included to reinforce the lecture material. Through the use of various scenarios, participants will learn how to assess and report AEs including SAEs.
Basic Methods (Day One). This section of the course will detail the basic and intermediate statistical concepts that are essential for professionals in the field. The first day emphasizes the principles of descriptive and inferential statistical applications and focuses on actual study examples, problem solving and interpretation of results. Throughout the course the participants are encouraged to ask questions and discuss examples relevant to their own work.
Advanced Topics (Day Two). This section of the course will go beyond the basics and cover more complex issues in laboratory investigations with examples.
This course is designed to provide participants with an understanding of the parameters for regulatory compliance, successful approaches to compliance, and meeting the concerns of regulators. Attendees will leave with a comprehensive set of tools for preparing regulatory initiatives, coping with challenges, and managing compliance.
Additional benefits of this class include:
•FDA authority and processes including 483s, Warning Letters, recalls, and other potential actions
•Update on FDA electronic submission procedures
•The benefits of a quality management system beyond the manufacturing environment
This course has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for 12 credits towards a participant's RAC recertification upon full completion.
Who Should Attend
This course is designed to provide attendees with a strong foundation for understanding the regulatory requirements of the US FDA. The content is ideal for those looking for an . . .
The European Union (EU) provides an attractive marketplace for medical device distribution. Development of requirements harmonized across the 27 member states should make it a straightforward process to get products approved in each country - but is it? This course works through the requirements for medical devices, the steps to obtain entry into the marketplace (including setting up a number of on-going procedures and relationships), and shares some lessons learned from the Course Director, who has over 20 years of experience with CE marking medical devices for distribution in the EU.
The course will introduce the Medical Device Directives (AIMD, MDD & IVDMDD), the meaning of the CE symbol and how & when to legitimately apply this mandatory mark of conformity, the significance of Notified Bodies, Competent Authorities, and Authorized Representatives. Additionally, the significance of the QMS, ISO 13485 and ISO 14971, and reference to ISO 14000 will be explained as necessary . . .
As users and regulatory agencies are becoming less ‘tolerant' of medical device failure, regulatory agencies are placing greater emphasis on post market surveillance as a way to improve risk management and protect public health. This course will review the regulatory expectations for post market surveillance and outline how to apply the requirements to medical devices. Topics include: complaint handling & vigilance systems, Medical Device Reports (MDR), implementation challenges, medical device tracking, impact of post approval studies, compliance requirements & meeting them, and complaint systems inspections.
Throughout the course, examples and case studies will help participants apply the concepts being covered.
Who Should Attend
This course will be of great value to medical device professionals involved in post market surveillance/complaint handling. It is primarily designed to benefit the following disciplines and personnel:
•Post Market Surveillance
•Complaint Assessment . . .
The guideline on "General Principals of Process Validation" was issued in May, 1987, and since then, medical device companies have struggled with the principals of process validation. Internationally, regulators believe through careful design and validation of the process and appropriate process controls, a manufacturer can establish a "high degree of assurance" that all manufactured units from successive lots will be acceptable. Successfully validating a process may reduce the dependence upon intensive in-process and finished product testing. More recently, with the introduction of risk management to medical devices, it is important to correctly apply the principles of risk management when implementing and maintaining process validation activities.
Newer products and processes pose additional challenges to organizations. New processes are more complex thereby making process validation more difficult. Using the tools developed in this course, participants will be able to . . .
The design of topically applied product formulation combines scientific knowledge in physics, chemistry, engineering and biochemistry and requires imagination and unique skills.
Throughout the design process, a thorough understanding of the fundamentals of skin structure, its pharmacology and mechanisms of delivery are paramount. In addition, knowledge of a formulation's physical properties, as well as ways of measuring its effects will provide for optimization of product development. Becoming knowledgeable with both aspects, one can extrapolate the possible interactions between a topically applied formulation and skin as a viable organ.
Over the past decade, both the pharmaceutical and cosmetic industries have gone through major changes that are primarily driven by consumer demand, aggressive market claims, regulatory issues and scientific breakthroughs.
This course provides participants with a thorough understanding of the topics listed above and will focus on methods needed . . .
The FDA and the FTC carefully monitor cosmetic products for non-substantiated and misleading claims. Regulatory agencies have increased their oversight of claims which mislead the consumer and result in the purchase of a product that will not deliver its promised benefit.
With the cosmetic industry striving to produce safer products, scientific resources must be highly focused on better testing products for their activity on the skin while simultaneously meeting all product claims. Establishing common criteria for justification of claims is a challenging aspect of product development since it needs to be customized for the purpose of use while matching the particular type of product.
This course is tailored to provide key aspects in the establishment of best practices for experimental design. Additionally, the program will cover methods for implementing a sound regulatory framework which will meet all government/agency requirements.
This GCP compliance training course provides a solid understanding of GCP requirements and a clinical compliance overview for clinical trials. The FDA supports clinical trial sponsors to use risk-based site monitoring. That's a plus for many sponsors, but you have to have the quality risk management system in place to make it work. This course teaches you how to ensure that your data and supporting documentation are completely accurate, factual and in the appropriate format for company and regulatory authorities. This will include practical knowledge on how to implement a risk-based monitoring approach to quality in clinical trials.
Attendees will gain experience in proven techniques for detecting, correcting and preventing clinical study deficiencies at domestic and international clinical sites by maximizing risk-based considerations. Included in the course work are practical examples and a roadmap for evaluating SOPs, consent forms, investigator brochures and source documents . . .
This GCP training course provides a solid understanding of GCP requirements and clinical quality assurance in detecting fraud and misconduct in clinical trials. Attendees will gain experience in detecting, correcting, and preventing clinical study misconduct and fraud at domestic and international clinical sites.
Additionally, attendees will learn how to ensure that their study conduct and supporting documentation is accurate and factual. The course will also address how to uncover misconduct, as well as, dealing with its consequences, while identifying proactive solutions to prevent further problems. Included in the course work are practical examples and a roadmap for evaluating study conduct, source documents, case report forms and other study documentation through presentation and interactive case studies.
Additionally, the course will cover methods to detect misconduct and deal with fraud in clinical trials by:
•Defining the basic requirements of Good Clinical Practices . . .
To formulate a successful sunscreen product for topical application requires a multidisciplinary approach. Factors need to be taken into consideration include the current market trends & demands, regulatory framework & compliance requirements, scientific learning on skin structure and function, UV-interacting chemistry & science, and appropriate delivery systems for optimal effectiveness and safety. This course will provide an overview of sunscreen regulations and technologies that enable the participants to design proper strategies for successful product development and marketing. In addition, small group discussion / workshops on real-life case studies will be conducted throughout the course to familiarize the participants with the complex regulatory framework and product labeling & advertising guidelines.
Regulatory agencies hold companies accountable for delivering high quality products that meet all established requirements and specifications. Suppliers and vendors play a key role in accomplishing these mandates and it is the company's responsibility to ensure their suppliers/vendors meet all regulatory specifications for the supplied materials, components, equipment and/or services.
For many years, industry has implemented procedures for selection, approval and qualification of suppliers and vendors. However, in many cases these protocols were not being implemented effectively or formally documented. Making these programs part of a risk-based quality system approach that the FDA and other regulatory agencies have come to expect from industry is critical. The course includes a process for selection, audit, approval and qualification of vendors/suppliers based on the material/equipment/service being delivered. These decisions must be documented and must be based on the impact . . .
In the eyes of regulatory authorities, the quality issues of biologics are definitely different from chemical drugs because of: (1) use of living source materials to produce the biologic, (2) increased complexity of biologic manufacturing processes and (3) increased complexity of the biologic molecules themselves. While chemical drugs can become generics, biologics products are best viewed as biosimilars, and not as bio-generics.
Biologics are highly susceptible to adventitious agent contamination – prions, viruses, mycoplasmas, and bacteria/fungi microbes. Risk control procedures – such as barriers to entry, testing to confirm absence, and inactivation/removal – are essential. Lessons can be learned from reported contaminations of biologic manufacturing processes. Compared to chemical drugs, biologics have a more complex process-related impurity safety profile, especially due to the living system-related impurities (e.g., host cell proteins, host cell DNA).
The content of this overview course will assist pharmaceutical, biotechnology, and CRO researchers and managers in understanding the requirements for a well-designed and successful ADME, PK/TK, and DM program conducted within a drug development logic plan and in compliance with ICH guidelines. The various types of ADME, PK/TK, and DM studies, which include in vitro metabolism and delivery, animal and human pharmacokinetics, protein binding, mass balance, tissue distribution, metabolite isolation and identification, and toxicokinetic support, will be discussed.
Study designs and potential results along with possible interpretations from each of the study types will be presented. The generation study reports and summaries, both of which are to be included in submissions to regulatory authorities for completed research experiments, will also be discussed.
Course Description - Course runs 9:00 to 5:00 both days
If you didn't write it down, it didn't happen! This is the position of the FDA and most regulatory agencies internationally. Good documentation is vital for doing business in the regulated world from discovery through marketplace. It is also important for due diligence and regulatory inspections, and is necessary for the success of your products and services. While the regulations tell you what you must do, they don't tell you how. Based on industry best practices, this course clarifies how to refine your existing system, create a new one, or prepare to transition from a manual system to electronic controls.
This course also addresses what documents you need to control, what documentation you need to support your actual system and how to keep your documents current and compliant.
Who Should Attend
Pharma, medical device, and biotech professionals who manage documents for all therapeutic product development and marketing . . .
This course provides practical guidance on cleaning validation regulatory compliance, in conjunction with process validation principles to facilitate reasonable and informed decision making and activity planning. Regulatory requirements and the latest industry practices will be included in the discussion to identify questionable practices that may be misdirected as well as the better practices that support and align with current process validation principles. The program will describe a risk-based approach for establishing an effective cleaning validation program, including the development of policies, master plans and the appropriate content for each study to be performed incorporating critical quality attributes and critical process parameters and process control. In addition, validation maintenance and life cycle aspects will be reviewed. Cleaning validation examples will be included from different sterile and non-sterile product types, and different types of dosage forms . . .
This two-day course will focus on the technologies used in pharmaceutical granulation compression and encapsulation including powder blending, dry and wet granulation, drying, compression and encapsulation. The course will focus particularly on the control technologies and how they interact with each other and on the product. It will be of benefit to scientists and technologists working in product development, manufacturing, production support, quality control and regulatory affairs.
This is a highly interactive course with plenty of opportunities for delegates to bring their own problems and topics of interest. On completing the course, attendees will have a thorough understanding of the technologies used to make tablets and capsules, and how these are applied to the control tablet and capsule manufacturing process.
Who Should Attend
This course has been created to assist those involved in all aspects of granulation, tableting and capsule technology. The course will be . . .
The course is designed to provide individuals with an in-depth awareness of the rules and procedures for filing variations and extensions. Understanding and applying the rules will ensure that you can file the variations successfully and avoid rejections.
The course will also provide the attendee with a thorough knowledge of the following topics:
•Overview of the different types of variations and the different procedures for a Marketing Authorisation in the EU
•The different types of variations (Type IA, Type IB, Type II)
•Variations involving product information
•How to deal with unclassified variations
Who Should Attend
This course is specifically designed for personnel in regulatory affairs of pharmaceutical and biotech companies who need to acquire basic knowledge or need to update their knowledge regarding filing variations.
This course will provide you with a comprehensive overview of filing variations, as well as addressing new regulations. . .
The Chemistry, Manufacturing & Controls (CMC) landscape of biologics is undergoing rapid development and constant change. Manufacturing processes now include transgenic plant cell cultures and transgenic animals. In addition to commercial recombinant proteins and monoclonal antibodies, there are now commercial cell-based medicines (cellular therapy) and DNA-based medicines (gene therapy). Biosimilars have been in the marketplace in Europe for almost a decade, and are now under review for commercial approval in the USA. Vaccine manufacturing has resurged due to the concerns of potentially pandemic mutated animal influenzas (e.g., swine flu, bird flu). Strategic international regulatory guidances have been adopted that are driving the entire pharmaceutical industry, including biologics, to a higher standard of performance, including Quality by Design (QbD), Quality Risk Management (QRM) and Pharmaceutical Quality System (PQS).
Therefore, it is most important for a biologic compa
This two-day course will explain the principles of dosage form design and how poor decisions at the design stage result in unstable processes and problem products. Product design should begin with identification of critical process and material parameters, but all too often this stage of the development is rushed and product yield and quality are compromised. Rectifying these problems retrospectively can be difficult and expensive. "Right first time" is the key to success.
This program will also identify the key elements of a successful product, along with some novel techniques which can be applied both as development and as troubleshooting tools. The course will benefit personnel working in formulation and product development, manufacturing, product support, and regulatory affairs. By achieving proper integration based on sound scientific principles, many development and production problems can be avoided. The course includes case studies of tablet formulation development and . . .
This two-day course is designed to provide individuals with a detailed understanding of the important regulatory guidelines involved in the development of a new product plan within the EU. The program will also cover effective strategies for correctly applying the current regulations to ensure that rejections are avoided.
The course will provide the attendee with a thorough knowledge of the following topics:
•How to develop a regulatory strategy
•How to deal with pricing and reimbursement issues in your development
•How to validate your regulatory strategy (scientific advice) and how to choose between centralized and national scientific advice
•When does your product qualify as an orphan medicinal product and what are the advantages if it does?
•How to deal with pediatric development plans
•What has to be considered for Advanced Therapy Medicinal Product and oncology medicinal products
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