Scientific Program

Conference Series Ltd invites all the participants across the globe to attend 6th International Conference and Exhibition on GMP, GCP & Quality Control Chicago, Illinois, USA.

Day 1 :

Keynote Forum

Robert P Bianchi

Prescription Drug Research Center, USA

Keynote: Government and industry response to the US opioid epidemic

Time : 09:30-10:00

GMP Summit 2017 International Conference Keynote Speaker Robert P Bianchi photo
Biography:

Robert P Bianchi is the President and Chief of Scientific and Technical Affairs at the Prescription Drug Research Center in Bradenton, Florida. Previously, he has spent 34 years in federal service as a Chemist at the FDA and DEA, including as Chief of the DEA’s Laboratory Operations Section, and the Director of the DEA Special Testing and Research Laboratory, where in-vitro studies were done more than 20 years ago. For the last decade, he has participated dozens of category 1 studies on abuse-deterrent opioid formulations, appeared as a panelist and presenter at abuse deterrent formulation and prescription drug abuse professional meetings. He has provided drug related consultations to more than thirty organizations/companies concerned about OTC and prescription drug abuse and has made numerous presentations to the treatment, pharmaceutical and law enforcement communities.

Abstract:

Prescription drug abuse has been declared an epidemic in America by the Centers for Disease Control and Prevention. According to the National Safety Council “Prescription Nation 2016”, the United States makes up 4.6% of the world’s populations but consumes 81% of the world supply of oxycodone. The FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs while assuring patient access. This is a responsibility shared with the pharmaceutical industry, treatment facilities, educational institutions, and Federal, state and local law enforcement agencies. Toward that end, the FDA issued Guidance for Industry in April 2015 under the title, "Abuse-Deterrent Opioids-Evaluation and Labeling", which contains the following statement:"The goal of the laboratory-based studies, Category 1, should be to evaluate the ease with which the potentially abuse-deterrent properties of a formulation can be defeated or compromised". The FDA also issued draft guidance for industry in March 2016 the “General Principles for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products”. This presentation will discuss abuse deterrent technology currently approved or in development and the required in vitro studies designed to evaluate extractability or tamperability. The FDA position on abuse deterrent delivery systems and the history of abuse deterrent opioid development will also be discussed. Studies on the efficacy of a new formulation to deter abuse will also be discussed.

GMP Summit 2017 International Conference Keynote Speaker Shane P Smith photo
Biography:

Shane P Smith is the Managing Director of ExtLe Solutions Limited, a company based in Cambridge in UK. He has over 30 years of experience in Industrial Analytical Chemistry, with well over half of that time spent in the Pharmaceutical sector. From 2004, he has worked for GlaxoSmithKline’s world class extractables and leachables team at Stevenage in the UK, managing projects for global cross-site project teams, and having ultimate responsibility for extractables and leachables sections of regulatory files submitted to agencies in North America, Europe and other territories. He has left GlaxoSmithKline in early 2016 to pursue a career as an Independent Consultant.

Abstract:

The subject of extractables and leachables has become an increasingly hot topic within regulatory agencies over recent years, especially with the increase of single use technologies in the manufacture of API/BDS and drug products. In addition, new guidance documents and pharmacopeial updates are driving the need for a thorough understanding of how extractables and leachables may affect the quality and efficacy of a drug product. This presentation will discuss key issues to consider whilst developing and executing a scientifically robust, and cost/resource effective GMP extractables and leachables strategy.

 

  • GMP in Food Industry | Current GMP Guidelines (cGMP) | Quality Assurance | Quality Control | Clinical Affairs & Regulatory Strategies Implementation
Location: Doubletree by Hilton Chicago North Shore
Speaker

Chair

Paul J Cummings

PJC Pharma Consulting Ltd, UK

Speaker

Co-Chair

Felix Amiri

Global Coalition for Sustained Excellence in Food & Health Protection (GCSEFHP), Canada

Session Introduction

Felix Amiri

Global Coalition for Sustained Excellence in Food & Health Protection (GCSEFHP), Canada

Title: Food industry Good Manufacturing Practices (GMPs) and the Safety, Security and Quality Assurance (SSQA) concept

Time : 11:20-11:40

Speaker
Biography:

Felix Amiri is the current food sector Chair of the Global Coalition for Sustained Excellence in Food & Health Protection (GCSE-FHP). He is a key contributor to the Safety, Security and Quality Assurance (SSQA) concept implementation manual published by Amiri Food Industry Support Services (AFISS). He also teaches International Food Safety Law and Regulations at Conestoga College. He has an in-depth knowledge of food safety and quality management systems. With more than 30 years of industry experience and an extensive knowledge of international standards, he serves as the Technical Director at AFISS, where he provides consulting services to various food companies. He also conducts system management and regulatory audits with SAI Global. Prior to his current role at AFISS, he worked in product development and quality management roles with various reputable companies, including Vese Food (Nigeria) Ltd., Unifine Richardson, Golden Valley Farms, Heinz (Martin Pet Foods) and YUM Brands.

Abstract:

The food industry has seen the adoption of different concepts and strategies for ensuring controlled and efficient implementation of GMPs. The evolution has continued from periods of no formalized systems to the introduction of highly sophisticated manufacturing management models. Many food companies have adopted well-known concepts such as: Total Quality Management(TQM); Strength, Weakness, Opportunity, Threat (SWOT) analysis; Failure Mode and Effects Analysis (FMEA) models; 6-S systems; Statistical Process Control (SPC); Statistical Quality Control (SQC); Six Sigma; Kaizen Methodologies; Lean Manufacturing; International Standards Organization (ISO) system; Hazard Analysis and Critical Control Point (HACCP) system; Global Food Safety Initiative (GFSI) Benchmarking system; et cetera. The overwhelming number of concepts has forced food companies to adopt them exclusively and in isolation. This creates both the necessity and the opportunity for the adoption of a synergy-building concept like SSQA. The SSQA model is a focused approach to managing GMPs, product safety, security and quality. The SSQA concept actively drives operations to search, recognize, investigate, adopt and expand upon winning ideas drawn from excellence-producing management approaches. The SSQA model is didactic, eclectic, organic and progressive. It brings together the theory and reality of product safety, security and quality assurance. SSQA directly and actively drives a collaborative engagement of all parties involved in the material supply, processing, distribution, utilization, regulation and independent assessment of operations with tools for ensuring and measuring success. Through a six-step implementation strategy, SSQA draws from other useful concepts and ensures resource utilization efficiency; effective implementation of programs, procedures and actions through the entire chain engagement process; team mobilization strategy; the tracking of exceptional success; failure analysis and control tracking; continuous analysis of realized effectiveness and efficiencies; and a HACCP system that addresses difficult-to-manage situations.

 

Sharmeen Reza

Cytel Statistical Software and Services Private Limited, India

Title: Quality control in statistical programming under GCP

Time : 11:40-12:00

Speaker
Biography:

Sharmeen Reza is the Director of Statistical Programming at Cytel Inc., a major functional service provider for pharmaceutical and biotech companies. Previously, she was the Biostatistical Programming Manager at Amgen. She has 20+ years of clinical background. On many occasions she gave presentations on quality control, trained new hires and helped them come up to speed. She has presented papers at conferences emphasizing the nature of collaboration in R&D and discussing statistical programming solutions.

Abstract:

Statistical programming to support clinical research and data analysis is vital in the drug discovery process. GCP is a prerequisite for any submission to regulatory authorities for drug approval and licensing. Quality control (QC) comes with different measures and tools following Standard Operating Procedures (SOPs), established by sponsor companies and/or Contract Research Organizations (CROs). The SOPs are mainly based on GCP guidelines. This presentation exhibits brief overview of QC in overall clinical trials, with focus on QC done right for statistical programming in a R&D environment. It gives relevant definitions, processes followed, reasons for QC, challenges faced, deviations and expectations. The topic also describes roles, expertise, requirements, documentation and responsibilities involved. Given a drug’s prospects, the impact of a solid QC process outweighs resource investments. Since quality is a key performance indicator and helps to select preferred partnership, pharmaceutical companies highly value CRO capabilities in conducting QC.

Chris Wubbolt

QACV Consulting LLC, USA

Title: Data integrity requirements for GxPs

Time : 12:00-12:20

Speaker
Biography:

Chris Wubbolt has provided quality assurance, compliance, and computer validation consulting services since 2001, specializing in establishing data integrity programs, performing data integrity audits, vendor audits, providing training, validation, and implementing six sigma based quality improvement processes. He has previously worked at Aventis Pasteur as Computer Validation Manager, working with GxP computerized systems. Prior to joining Aventis Pasteur, he worked at Johnson & Johnson’s McNeil Consumer Products Company in the National Quality Assurance Group and at Lancaster Laboratories. He was a contributing member of the GAMP Laboratory Systems Special Interest Group, which published the guidance document on validation of laboratory systems, as well as a chapter chair for DIA “Peach” guidance on computerized systems used in clinical research. He is a Certified Six Sigma Black Belt, has a Master’s degree in Quality Assurance and Regulatory Affairs and a BS in Physics and Computer Engineering. He was the previous President of both the New England Region Chapter Society of Quality Assurance (NERCSQA) and the Mid-Atlantic Region Society of Quality Assurance (MARSQA), and is currently the chairperson of the MARSQA computer validation committee.

Abstract:

This presentation will provide an overview of current regulatory requirements and guidance pertaining to data integrity. The presentation will review FDA, MHRA and other regulatory guidance related to data integrity. Approaches to performing data integrity assessments will be discussed and examples from audits and regulatory observations will be reviewed. Implementation of data integrity programs will also be reviewed. The following topics will be discussed at the conference: Review current regulatory data integrity requirements and guidance; approaches to conduct audits / assessments of data integrity programs; examples of data integrity observations and audit findings and; implementing data integrity programs.

 

Mayra Guzman-Kaslow

GK Regulatory, Compliance, & Engineering Consulting Corporation, USA

Title: Regualtory compliance & notified bodies inspection readiness

Time : 12:20-12:40

Speaker
Biography:

Mayra has two BS, (1) in Chemistry, and (2) in Chemical Engineering from the University of Puerto Rico, and a Master of Sciences, in Thermodynamics and Materials Sciences Engineering from the University of Cincinnati, OH. She is the President of GK Regulatory Compliance Corp., and the Chairman of GK Bio-Pharmaceuticals CMO - PR a premier Bio-Pharmaceuticals Contract Manufacturing Organization locaded in Vega Baja, PR. She has a track-record of accomplishment for consistently meeting goals and delivering a high level sustained performance, proven the ability to build strong customer/client relationship including conducting vendor audits and contract manufacturing oversight. She has been a key element in the Regulatory Compliance Readiness for Major Pharmaceuticals, APIs, Biotech, Biosimilars, CMOs.

Abstract:

“Inspection Readiness” is a site-preparation activity often done in anticipation of an upcoming third party audit, due diligence activity, FDA inspection, Notified Body inspection, or other Regulatory Agency inspection. FDA inspectors have a limited amount of time at a facility to gather a large amount of data and evaluate your respective product/facility/quality system. Similarly, pharmaceutical companies have a limited amount of time to make a positive impression with the inspection team, convey relevant information, and ensure a favorable outcome. Inspection Readiness is the best way to prepare for an onsite inspection. Inspection Readiness is not typically an activity that is done internally. Having an outside perspective is a critical component to effectively evaluating your quality systems, facilities, and personnel. Inspection Readiness is one of the best ways to utilize an outside resource. Experienced consultants that have worked with a variety of companies will give the best perspective. FDA inspections are assigned for many different reasons. Safety (risk to health) plays a major role in how FDA selects firms for inspections. Firms can estimate their likely risk status in terms of FDA’s regulatory interest. Once a firm is selected for inspection, how the inspection is conducted becomes a make-or-break situation. Inspections are designed to find problems. They are inherently uncomfortable for the people who host the investigator during the inspection. Predicting what an investigator will do during an inspection becomes helpful in how you manage a difficult situation to avoid a potentially disastrous and costly result. In order for Inspection Readiness to be effective, it must be objective and have the full support of senior management.

 

Rashid Mehmood

Surge Laboratories Private Limited, Pakistan

Title: Quality risk management system

Time : 12:40-13:00

Speaker
Biography:

Rashid Mahmood has a Master’s degree in Analytical Chemistry and MS in Total Quality Management. He has 13 years of experience in Pharmaceutical Quality Operations and has attended many international conferences as a keynote speaker. He has presented various talks in USA & China on Cleaning Validation, cGMP Guidelines and Quality Risk Management. Currently, he is working as a Senior Executive Manager Quality Operations for Surge Lab (Manufacturer of Microencapsulated APIs, Liquid & Dry Powder Parentrals) which is the best export oriented company in Pakistan.

 

Abstract:

In the pharmaceutical industry every product and every process will be associated with risks. To maintain product quality throughout the product life cycle, too much time and resources are allocated. Risk is described in – recent guidance as a combination of the probability of occurrence of harm and the severity of that harm. The Quality Risk Management (QRM) approach initiated by regulatory agencies with recognized management tools along with support of statistical tools in combination allows for a risk based approach to quality management, thus ensuring that resources are deployed in a timely and expeditious manner to areas that need them most. QRM improves risk awareness and accelerates detection of potential issues by analyzing and comparing existing data from a quality perspective to manage product quality, manufacturing processes, validation and compliance within a risk based Quality Management System. In addition quality risk management improves decision making if a quality problem arises. It should include systemic processes designated to co-ordinate, facilitate and improve science based decision-making with respect to risk. Quality Risk Management can be applied not only in the manufacturing environment, but also in connection with pharmaceutical development and preparation of the quality part of marketing authorization dossiers. The guideline applies also to the regulatory authorities in the fields of pharmaceutical assessment of the quality part of the marketing authorization dossier, GMP inspections and the handling of suspected quality defects. ICH Q9 - Quality Risk Management provides an excellent high level framework for the use of risk management in pharmaceutical product development and manufacturing quality decision making applications. It is a landmark document in acknowledging risk management as a standard and acceptable quality system practice to facilitate good decision-making with regard to risk identification, resource prioritization and risk mitigation / elimination, as appropriate