Webinar Duration: 60 minutes
RECORDED: Access recorded version only for one participant; unlimited viewing for 6 months (Access information will be emailed 24 hours after the completion of payment)
SPEAKER: Lamont M. Fulton
Pharmaceutical firms must establish clear process of selecting a Contract Manufacturing Organization to perform the selected task or need. It is incumbent on the Pharmaceutical firm, large or small, to develop a criteria for evaluating a CMO.
The CMO must perform per standards and meet the needs as a stated in supplier of services agreement. The contract should follow or use as a guideline, The FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements.
Thus a preliminary internal discussion within the Pharmaceutical firm should be conducted to study quality and reliability issues of all critical items under consideration before being outsourced to a CMO.
The CMO supplier must be evaluated and a set of protocols and direct communication channel created to ensure that any potential issues can be quickly addressed. The Selection of a CMO is not easy, however the road to a successful relationship can be achieved through appropriate assessment of your firm’s needs and the CMO ability to perform.
Why should you Attend: To assess your specific needs in the area of pre-formulation, to formulation, and pre-clinical research, as well as clinical research, including method development, scale-up, and manufacturing/commercialization of the drug product. It is imperative that those individuals responsible for these areas establish a clear list of objective to help identify potential CMO candidates.
The FDA recommends that Owners develop quality management principles and quality agreements to delineate the various types of activities in drug manufacturing operations, including processing, packing, holding, labeling operations, testing, and quality control operations.
All quality management folk (quality unit) should be involved with the selection and evaluation of a contract facilities compliance with CGMP. Thus those individuals involved with audits as well as contract negotiations should follow the FDA’s Guidance for Industry Contract Manufacturing Arrangements for Drugs: Quality Agreements.
Areas Covered in the Session:
– Identification of your (owner) needs
– List clear objective requirements (operations and activities)
– Meeting CGMP requirements (performing audit,)
– Following ICH guidelines:
– Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
– Q9 Quality Risk Management
– Q10 Pharmaceutical Quality System
– Establishing a partnership
– Identify roles and responsibility for owner and contractor (change controls)
– Finalizing Quality Agreement
Who Will Benefit:
– Quality Unit (Laboratory Control)
– Regulatory Affairs(Change Control, Documentation)
– Materials Management
– Facilities and Equipment
Mr. Lamont Michael Fulton is President of Regulatory Direction LLc and has over Forty years of Pharmaceutical experience (26 in regulatory affairs CMC).He has had roles as both Manager and Director of Chemistry Manufacturing and Controls (CMC) Regulatory and labeling at both Branded (Merck, SmithKline, Wyeth) and Generic drugs firm (Mylan). Prior to working as the leader to regulatory affairs departments, Mr. Fulton worked at the FDA as a Chemist reviewer in the center for drugs. While at the FDA, He also worked as an Analyst in the office of regulatory affairs and international office of policy, dealing with FDA/ICH regulations and guidance for global initiatives.
Mr. Fulton’s past experience in government and industry, including his current role as senior consultant, has allowed him the opportunity to develop relationship with various CMC partners (Pfizer, Johnson and Johnson, Bristol Myers Squibb, etc.). It has also afforded his consultancy the chance to assist and manage other multidisciplinary teams achieve approval for dozens of NDA’s, ANDA’s to the FDA, as well as provide help with several successful international drug applications to the EMEA, MHLW and ROW. The blended years of both pharmaceutical quality and regulatory affairs has provided Mr. Fulton with a perspective to determine appropriate filing strategy and provide regulatory impact of changes in post Marketing products.
Mr. Fulton has BA degree in Chemistry from Cheyney University of Pennsylvania; where he studied under Dr.Taylor on the nature of terpenes and its various derivative. Certificate of Pharmaceutical training from University of Maryland school of Pharmacy / FDA program. Mr. Fulton’s affiliations included; GPhA (Generic Pharmaceutical Association), ACS American chemical society) RAP (Regulatory Affairs Professional society), PDA (Parenteral Drug Association); Sigma Xi.